Q Pharma Quality Manual
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DOCUMENT TYPE
DOC NO.
Qualit ality y Mana anagemen ementt Polic licy
QMP-0 MP-00 01
REVISION
1.0
TITLE
PAGE
Q Pharma Quality System Manual
1
ISSUED BY
EFFECTIVE DATE
of 32 SUPERCEDES
rJ Boatman
16 Feb 2007
CSSC QSM-001 iPT QSM-001
QUALITY MANAGEMENT POLICY QUALITY SYSTEM MANUAL QMP-001 Rev. 1.0 Prepared by
Date
(Signed)
01 Feb 2007
Reviewed by
Date
(Signed)
07 Feb 2007
Reviewed by
Date
Jeff Boatman, Director of Quality
Alexis Stroud, Compliance Manager
(Signed) Raymond Roggero, iPT Business Unit Manager
2/7/07
Reviewed by
Date
(Signed) Robert Lorence, CSSC Business Unit Manager
9 Feb 2007
Approved by
(Signed) Patrick Den Boer, President and CEO
Date
16 Feb 2007
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TABLE OF CONTENTS 0.
1.
2.
3. 4.
5.
6.
INTRODUCTION INTRODUCTION ........................................................ .................................................................................................................... ............................................................ .....4 0.1 General...............................................................................................................................4 0.2 Process Approach ................................................. .................................................... .............................................................4 .........4 0.3 Relationship Relationship with ISO 9004..................................... .................................................... ..........................................................5 ......5 0.4 Compatibility Compatibility with Other Management Management Systems................................. .............................. 5 SCOPE ............................................................ ........................................................... ....................6 .................... 6 1.1 General...............................................................................................................................6 1.2 Application.........................................................................................................................6 1.3 Exclusions..........................................................................................................................7 1.4 Organization.......................................................................................................................8 NORMATIVE REFERENCE............................. REFERENCE.......................................................................................... ............................................................. ............11 2.1 General.............................................................................................................................11 2.2 Model ................................................... ........................................................ ............................................................................ ....................11 11 2.2.1 Quality Processes ................................................................................................11 TERMS AND DEFINITIONS.................................................................... ................................. 12 QUALITY MANAGEMENT SYSTEM ................................................... .................................. 14 4.1 General Requirements............................................... Requirements............................................... ................................................... ....14 4.2 Documentation Documentation Requirements............................................ Requirements............................................ .............................................. 14 MANAGEMENT RESPONSIBILITY...................................................... RESPONSIBILITY...................................................... .................................. 17 5.1 Management Management Commitment................................................................ Commitment................................................................ ............................... 17 5.2 Customer Customer Focus ....................................................... ............................................................................................................. ........................................................17 ..17 5.3 Quality Policy ................................................ ................................................... ...............17 5.4 Planning ................................................. ....................................................... .......................................................................... ...................18 18 5.4.1 Quality Objectives................................................................................................18 5.4.2 Quality Management System Planning................................................................18 5.5 Responsibility, Responsibility, Authority, and Communications............................................................ Communications............................................................ .18 5.5.1 Responsibility and Authority................................................................................18 5.5.2 Management Representative................................................................................18 5.5.3 Quality Review Board (QRB)...............................................................................19 5.5.4 Internal Communications ....................................................................................19 5.6 Management Management Review ............................................. .................................................... ..........................................................19 ......19 5.6.1 General ................................................................................................................19 5.6.2 Review Inputs.......................................................................................................19 5.6.3 Review Outputs ...................................................... .................................................................................................... .............................................. 20 RESOURCE RESOURCE MANAGEMENT........................................ ........................................................... 20 6.1 Provision of Resources Resources .................................................. .................................................. 20 6.2 Human Resources Resources ................................................... ....................................................... .........................................................20 ..20 6.2.1 General ................................................................................................................20 6.2.2 Competence, Competence, Awareness, and Training ........................................................... ....20 6.2.3 Personnel Management .......................................................................................20 6.3 Infrastructure....................................................................................................................21 6.4 Work Environment........................................................ Environment........................................................................................................... ................................................... 21 6.4.1 Review..................................................................................................................21 2007 Q Pharma Inc. Unauthorized Unauthorized reproduction or distribution prohibited. prohibited. CONTROLLED DOCUMENT
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TABLE OF CONTENTS 0.
1.
2.
3. 4.
5.
6.
INTRODUCTION INTRODUCTION ........................................................ .................................................................................................................... ............................................................ .....4 0.1 General...............................................................................................................................4 0.2 Process Approach ................................................. .................................................... .............................................................4 .........4 0.3 Relationship Relationship with ISO 9004..................................... .................................................... ..........................................................5 ......5 0.4 Compatibility Compatibility with Other Management Management Systems................................. .............................. 5 SCOPE ............................................................ ........................................................... ....................6 .................... 6 1.1 General...............................................................................................................................6 1.2 Application.........................................................................................................................6 1.3 Exclusions..........................................................................................................................7 1.4 Organization.......................................................................................................................8 NORMATIVE REFERENCE............................. REFERENCE.......................................................................................... ............................................................. ............11 2.1 General.............................................................................................................................11 2.2 Model ................................................... ........................................................ ............................................................................ ....................11 11 2.2.1 Quality Processes ................................................................................................11 TERMS AND DEFINITIONS.................................................................... ................................. 12 QUALITY MANAGEMENT SYSTEM ................................................... .................................. 14 4.1 General Requirements............................................... Requirements............................................... ................................................... ....14 4.2 Documentation Documentation Requirements............................................ Requirements............................................ .............................................. 14 MANAGEMENT RESPONSIBILITY...................................................... RESPONSIBILITY...................................................... .................................. 17 5.1 Management Management Commitment................................................................ Commitment................................................................ ............................... 17 5.2 Customer Customer Focus ....................................................... ............................................................................................................. ........................................................17 ..17 5.3 Quality Policy ................................................ ................................................... ...............17 5.4 Planning ................................................. ....................................................... .......................................................................... ...................18 18 5.4.1 Quality Objectives................................................................................................18 5.4.2 Quality Management System Planning................................................................18 5.5 Responsibility, Responsibility, Authority, and Communications............................................................ Communications............................................................ .18 5.5.1 Responsibility and Authority................................................................................18 5.5.2 Management Representative................................................................................18 5.5.3 Quality Review Board (QRB)...............................................................................19 5.5.4 Internal Communications ....................................................................................19 5.6 Management Management Review ............................................. .................................................... ..........................................................19 ......19 5.6.1 General ................................................................................................................19 5.6.2 Review Inputs.......................................................................................................19 5.6.3 Review Outputs ...................................................... .................................................................................................... .............................................. 20 RESOURCE RESOURCE MANAGEMENT........................................ ........................................................... 20 6.1 Provision of Resources Resources .................................................. .................................................. 20 6.2 Human Resources Resources ................................................... ....................................................... .........................................................20 ..20 6.2.1 General ................................................................................................................20 6.2.2 Competence, Competence, Awareness, and Training ........................................................... ....20 6.2.3 Personnel Management .......................................................................................20 6.3 Infrastructure....................................................................................................................21 6.4 Work Environment........................................................ Environment........................................................................................................... ................................................... 21 6.4.1 Review..................................................................................................................21 2007 Q Pharma Inc. Unauthorized Unauthorized reproduction or distribution prohibited. prohibited. CONTROLLED DOCUMENT
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6.4.2 Safety....................................................................................................................21 6.4.3 Client Sites ................................................... .................................................... ........................................................22 ....22 6.4.4 Remote Offices ........................................... .................................................... ..........................................................22 ......22 PRODUCT REALIZATION REALIZATION .................................................... ....................................................................................................... ................................................... 22 7.1 Planning of Product Realization Realization Processes................................................................... ...22 7.2 Customer-Related Customer-Related Processes......................................... ................................................... 22 7.2.1 Determination Determination of Customer Requirements .......................................................... 22 7.2.2 Review of Customer Customer Requirements Requirements .................................................. ....................23 .................... 23 7.2.3 Customer Communications..................................................................................23 7.3 Design and Development Development.............................................. .............................................. ................................................... 23 7.3.1 Design and Development Planning Planning .................................................................. ...24 7.3.2 Design and and Development Development Inputs Inputs ............................................. ............................. 24 7.3.3 Design and Development Development Outputs ....................................................................... 24 7.3.4 Design and Development Development Review ..................................................................... ...25 7.3.5 Development Development Verification Verification .............................................. ...................................... 25 7.3.6 Project Completion Completion ............................................... ............................................... 25 7.3.7 Change Control....................................................................................................25 7.4 Purchasing........................................................................................................................25 7.4.1 Purchasing Purchasing Processes................................................... Processes ................................................... ....................................... 26 7.4.2 Purchasing Information.......................................................................................26 7.4.3 Verification Verification of Purchased Products................................... Products..................................................................... .................................. 26 7.5 Service Provision ............................................. .................................................... ................................................................26 ............26 7.5.1 Control of Service Provision................................................................................26 7.5.2 Validation of Service Provision Provision Processes Processes........................................ .......................................................... ..................27 27 7.5.3 Identification Identification and Traceability Traceability ................................................ ............................ 27 7.5.4 Customer Property...............................................................................................27 7.5.5 Preservation of Product.......................................................................................28 7.5.6 Control of Monitoring Monitoring and Measuring Measuring Equipment Equipment ........................................ ..............................................28 ......28 MEASUREMENT, MEASUREMENT, ANALYSIS, AND IMPROVEMENT IMPROVEMENT ........................................................ 28 8.1 General.............................................................................................................................28 8.2 Monitoring and Measuring ............................................... ............................................... 29 8.2.1 Customer Satisfaction Satisfaction .............................................. ............................................ 29 8.2.2 Internal Audits .....................................................................................................29 8.2.3 Monitoring and Measurement Measurement of Processes ........................................................ 29 8.2.4 Monitoring and Measurement Measurement of Product ................................................. ..........30 8.2.5 Control of Nonconforming Product.....................................................................30 8.2.6 Analysis of Data...................................................................................................30 8.3 Improvement....................................................................................................................31 8.3.1 Continual Improvement .......................................................................................31 8.3.2 Corrective Action.................................................................................................31 8.3.3 Preventive Action.................................................................................................31 REVISION HISTORY................................................................................ ................................. 32
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Quality System Manual 0.
INTRODUCTION
0.1
GENERAL
Page 4
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Q Pharma is a Life Sciences management company headquartered in Morristown, New Jersey. Q Pharma provides Top Management oversight and direction to its subsidiary organizations, consisting of CSSC Incorporated (“CSSC”), a validation and compliance consulting company integrated Pharma Technologies (“ iPT”), a drug sample accountability and regulatory consulting company Q Logistics, a pharmaceutical warehouse and order fulfillment company • •
•
This Quality System Manual specifies requirements and policies for Q Pharma to address customer satisfaction, to meet customer and applicable regulatory expectations, and to meet ISO 9001 requirements. 0.2
PROCESS APPROACH Q Pharma has adopted the ‘Process Approach’ in developing, implementing, and improving the effectiveness of quality systems to enhance customer satisfaction. This approach centers on the “Plan—Do—Check—Act” concept shown below. Plan – Establish objectives and processes to fulfill customer requirements in accordance with company policies. Do – Implement processes. Check – Monitor and measure process outputs against objectives and requirements and report the results. Act – Continuously improve process performance based on metrics. •
• •
•
CUSTOMER NEEDS
Manage Resouces
REQUIREMENTS (Input)
Information
Realize Product
Management Responsibility
PRODUCT (output)
Measure, Analyze, Improve
Continuous Improvement
Information CUSTOMER SATISFACTION
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Q Pharma uses this approach to implement, control, evaluate and improve its business processes and to provide direction and goals for its subsidiaries. Because Q Pharma’s subsidiaries work in different fields within regulated Life Sciences and are subject to different regulations, the Q Pharma Quality Management System is divided into those elements and processes which apply to all subsidiaries (which are managed directly by Q Pharma), and those that apply specifically to the field in which a subsidiary is engaged (described by the quality system of that subsidiary). Q-Pharma Top Management
Project Management
Document & Record Control
Subsidiary Management
Project Managers
Customer Data
Information Technology
Quality Management
Management Responsibility
Analysis & Improvement
Resource Management
Resource Allocation
Product Realization
Quality Assurance and Control
S U P P O R T PROCESSES COMPLIANCE • Internal Auditing • Regulatory • Safety
0.3
FACILITIES • Infrastructure
FINANCE • Accounts Payable • Accounts Receivable • Administaff Liason
SALES & MARKETING • Initial Definition of Customer Needs • Customer Satisfaction Liason
RECRUITING • Projects (PM) • Augmentation (Sales)
CORPORATE TRAINING • Internal • Customer • Industry certification
HUMAN RESOURCES • Outsourced vendor
RELATIONSHIP WITH ISO 9004 This Quality Manual specifically concentrates on policies that directly enhance customer satisfaction and address business needs. Management may refer to ISO 9004:2000, Quality Management Systems – Guidelines for Performance Improvements for guidance on continuous improvement of the Quality Management System.
0.4
COMPATIBILITY WITH OTHER MANAGEMENT SYSTEMS Q Pharma and its subsidiaries are engaged in a highly regulated industry, and its policies must conform to regulations and management systems specific to its business. Where beneficial to the objective of demonstrating leadership in Life Sciences, the Quality Management System may also incorporate applicable elements of 21 CFR 820, the U.S. Quality System Regulation for Medical Devices. • •
•
iPT
is also subject to compliance with 21 CFR Part 203 Q Logistics is also subject to compliance with 21 CFR Parts 203, 205, and portions of 211, as well as applicable state legislation for licensing and reporting Q Pharma and all subsidiaries may be subject to compliance with 21 CFR Part 11 (electronic records) and will determine the extent of compliance required based on current FDA guidance
Where a conflict exists between ISO 9001 and a federal regulation specific to the business of a Q Pharma subsidiary, the applicable regulation takes precedence. 2007 Q Pharma Inc. Unauthorized reproduction or distribution prohibited. CONTROLLED DOCUMENT
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1.
SCOPE
1.1
GENERAL
1.2
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1.1.1
The original copy of this Quality System Manual is maintained in the secure Document Master File storage area at the headquarters of Q Pharma, Inc. at 22 South Street, Morristown, N.J. 07960.
1.1.2
The authority to establish the Q Pharma Quality System is contained in a letter from Patrick Den Boer, Chief Executive Officer, dated January 8, 2007, and stored in the Quality Manual section of the Document Master File.
1.1.3
It shall be the policy of Q Pharma to pursue, implement, champion, and advance systems and procedures that meet internationally recognized standards of excellence applicable to the business and pertinent to customer fulfillment. Such standards shall be pursued and followed regardless of any formal registration, certification, or recognition.
1.1.4
This Quality System Manual defines the policies that shall be adhered to in developing and executing business processes and procedures.
APPLICATION 1.2.1
The Quality Management System defined in this Quality System Manual, and implemented through the documentation and training described herein, shall guide Q Pharma personnel in their development and implementation of company processes.
1.2.2
Q Pharma is a company devoted to providing services in validation, project management, drug distribution and control, sample tracking, quality improvement, and compliance expertise to Life Science companies. Q Pharma’s core competency is in the Life Sciences field with specialization in compliance and distribution in regulated industries.
1.2.3
Q Pharma does not develop, produce, or market regulated Pharmaceuticals or Medical Devices. However, its core customer base is engaged in such business. Since these clients look to Q Pharma for assistance, Q Pharma must necessarily conduct its own business to the highest levels of quality and workmanship.
1.2.4
The ultimate mission of Q Pharma is to provide services that meet customer needs. The processes that Q Pharma deploys to implement the Quality Management System must take into account the actual requirements of each individual customer, and be flexible enough to utilize and capitalize on the customer’s own existing system when applicable.
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EXCLUSIONS Q Pharma has not fully implemented the following elements of ISO9001:2000 through its Quality Management System:
Sections
§7.3.1, Design and Development Planning §7.3.3, Design and Development Verification §7.3.4, Design and Development Review
Exclusion
Q Pharma shall plan and control the development of product and verify and review outputs against plans and client requirements for in-house development projects or when a Q Pharma subsidiary has contractual responsibility for Project Management.
Justification
Q Pharma subsidiaries may perform work where the client or a third-party retains control of development planning activities.
Exclusion
Reviews do not take place at predetermined stages but as appropriate to project scope and complexity.
Justification
Every project is unique and predetermined staged review may not always be appropriate.
Section
§7.3.6, Design and Development Validation
Exclusion
Q Pharma shall validate internal systems and software having a direct impact upon product quality.
Justification
Validation does not apply to work produced by CSSC; instead, such work is subject to client review, approval, and feedback. §7.3.6 does apply to systems development in support of i PT and Q Logistics operations.
Section
§7.4, Purchasing
Exclusion
Purchasing procedures shall be limited to fulfillment of business needs, vendor metrics, and customer satisfaction, unless specifically called out otherwise.
Justification
Q Pharma does not design products or market services that require rigorous specifications for purchased materials. While not “purchased” product per se , Q Logistics performs incoming and in-process inspections on drug product (customer property) shipped to and from customers.
Section
§7.5, Production and Service Provision
Exclusion
This section applies solely to service provision.
Justification
Q Pharma does not manufacture any product.
Section
§7.5.5, Preservation of Product
Exclusion
This section does not apply to CSSC and i PT.
Justification
CSSC and i PT products are services and corresponding documentation. Specialized handling, packaging, storage, and protection is not necessary to preserve the product.
Section
§7.5.6, Control of Monitoring and Measurement Equipment
Exclusion
Only equipment used in ongoing internal processes are subject to routine calibration and preventive maintenance.
Justification
Any Q Pharma metrology equipment used for client projects are calibrated and verified for that project at client expense and per specified client requirements.
Section
§8.3.2, Corrective Actions and §8.3.3, Preventive Actions
Exclusion
Q Pharma does not maintain separate processes for Corrective Actions and Preventive Actions but handles both under a single system.
Justification
Q Pharma has determined that the single-system approach, described in 21 CFR 820.100 (as authorized by §0.4 of this Quality System Manual) is appropriate to Q Pharma’s business. 2007 Q Pharma Inc. Unauthorized reproduction or distribution prohibited.
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ORGANIZATION Q Pharma shall define, maintain, plan, and staff an organization applicable to the Quality Management System and appropriate to current and projected customer needs. A Master Quality Organization Chart, approved by the President, shall supplement this Quality System Manual and be available to all persons in the company. This chart shall describe the key positions within the Quality Management System, their functional relationships, the names of personnel currently appointed to those positions, and any authorized alternates. 1.4.1
The President is responsible for appointing personnel to such key positions. Unless specifically otherwise required by procedures, such appointment is documented by the President’s approval of the Master Quality Organization Chart that reflects the appointment.
1.4.2
Other organizational charts, such as lists of all current personnel, team breakdowns, etc., are permitted but shall not contradict the Master Quality Organization Chart.
1.4.3
The definition, establishment, implementation, maintenance, and continuous improvement of the Q Pharma Quality Management System are the responsibility of personnel listed in this section. The President shall publish and keep current the Master Quality Organization Chart listing, at a minimum, the names of each individual currently filling each title and role described in this section. This chart shall be maintained with the original copy of this Quality System Manual, copies made available to all personnel, and obsolete copies archived. A single individual may have more than one title on either a permanent or ad hoc basis. Note: Q Pharma officers are captured on the Master Quality Organization Chart but their appointment is outside the scope of the Q Pharma Quality Management System. Officer responsibilities cannot be assigned temporarily and cannot be delegated. While every Q Pharma colleague and contractor is expected to implement the Quality Management System, QMS shaping, enforcement, and leadership is demanded of Top Management , who: • •
•
determine the overall business strategy, scope, and direction; are charged with overall responsibility to formulate, shape, establish, and implement policies for their specific organizations and functions; and have authority over compliance, policy implementation, resources, and issue identification and resolution to ensure that business directives and quality policies are adhered to.
1. The President (and Chief Executive Officer) is responsible for establishing the strategic vision and business strategies of the company and is ultimately responsible for ensuring customer satisfaction through the establishment, communication, and 2007 Q Pharma Inc. Unauthorized reproduction or distribution prohibited. CONTROLLED DOCUMENT
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implementation of policies; providing leadership and company vision; and establishment of company quality goals and objectives and evaluation of the company quality improvement processes. The President determines the company quality structure and communicates this through organizational charts and Quality Management Policies, including this Quality System Manual. 2. The Chief Financial Officer (CFO) is responsible for overseeing all company finances. These duties typically include the establishment of, implementation of, and adherence to, controls involving the transfer and safeguarding of all company funds. Other duties include ensuring the fair and accurate reporting of financial activities to regulatory authorities and lending institutions, the proper raising of capital to fund business activities, the proper allocation of the company’s financial resources to support its activities, and ensuring the prompt resolution of billing issues with clients and vendors. 3. The Chief Information Officer (CIO) is responsible for overseeing all electronic records used by Q Pharma personnel in support of the Quality Management System. These duties include the preservation, control, retrieval, and archival of electronic records and providing the tools and infrastructure necessary to create and use electronic records. The CIO has primary responsibility for forecasting electronic record resource requirements and ensuring that adequate systems are acquired, deployed, and maintained. 4. The Vice-President of Sales and Marketing (VPSM) directs, establishes, maintains, and plans the overall policies and goals for the business development department; identifies potential business partners and negotiates agreements; generates and nurtures partner relationships for collaborative service offerings to industry; and ensures that the Q Pharma customer feedback program is effectively implemented. 5. Each Q Pharma subsidiary is headed by a Business Unit Manager , responsible for overseeing company operations on a day-to-day basis, including assignment of resources and management and identification of anticipated resource needs and qualifications to meet future customer requirements; customer relations, including prioritization and issue resolution; contract development and review; and establishment and enforcement of compliance, training, and evaluation policies. The Business Unit Manager ensures that Q Pharma’s technical and regulatory personnel receive an accurate and detailed scope of work for client projects and communicate with clients to ensure that their project needs are fully and properly documented. 6. The Vice-President of Project Management (VPPM) is responsible for ensuring the qualifications of project managers to meet customer and deliverables requirements through training in management tools, processes, and metrics; shaping the scope and curriculum of management training; recruiting and procuring skilled personnel; collecting, evaluating, and affecting improvement of company-wide management 2007 Q Pharma Inc. Unauthorized reproduction or distribution prohibited. CONTROLLED DOCUMENT
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metrics; oversight of internal training processes; and developing Project Management as a standalone product for customers. 7. The Director of Quality is responsible for development and implementation of the Q Pharma Quality System; shaping and establishing quality standards of products and performance; tracking, review, and approval of internal documentation and, where specified, customer deliverables; internal auditing and corrective actions; internal quality training and metrics; and development of quality services as a standalone product for customers. Unless otherwise directed by the President, the Director of Quality is also the Management Representative, responsible for the implementation of the Quality Management System irrespective of other duties. Management Representative duties are further discussed in §5.5.2. In addition to Top Management, the following persons play key roles within the QMS: 1. The Compliance Manager is responsible for enforcing company and client standards on Q Pharma personnel through audits and reviews of activities, records, and deliverables; maintaining compliance with government and industry quality, regulatory, and safety standards through employee training and communication; and initiating corrective actions. 2. The Purchasing Manager is responsible for oversight of the company purchasing system, including enforcement of purchasing procedures and verifying that purchase requirements are sufficiently clear and appropriately authorized. Subsidiaries may employ Regional Directors to supervise projects and personnel from remote offices. Regional Directors report to a Business Unit Manager, but because of their geographical distance, they may also assume responsibilities delegated from Project Management, Finance, and Sales and Marketing; and may have functional delegation of Compliance and Quality Assurance duties. 1.4.4
Q Pharma Organizational Structure President Q Pharma
Chief Financial Officer
VP Sales & Marketing
Dir. of Project Management
Purchasing Manager
Chief Information Officer
Dir. of Quality Mgmt Rep
CSSC Business Unit Manager
i PT Business Unit Manager
Q Logistics Business Unit Manager
Compliance Manager Regional Directors
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1.4.5
When a position in the Quality Management System is open, undesignated, or otherwise not being fulfilled as the responsibility of a specific individual, the next-higher manager assumes ad hoc responsibility for that task, with one exception: there must always be a specific person assigned as the Management Representative.
1.4.6
Other positions under the Quality Management System may be required as documented by Controlled Documents implementing Quality Management System. Such documents shall describe the position and its authorities and responsibilities, as well as describing how appointments to that position shall be documented.
1.4.7
Unless otherwise specified, appointment to a position within the Quality Management System shall be designated by inclusion on the Master Quality Organization Chart.
2.
NORMATIVE REFERENCE
2.1
GENERAL Q Pharma is engaged in the business of providing services and expertise to highly regulated industries, in which both customers and the regulatory agencies that oversee them demand quality and continuous improvement. The Quality Management System is intended to meet the expectations that regulatory agencies have of Q Pharma’s clients.
2.2
MODEL The Q Pharma Quality Management System is based upon the structure and guidelines of ISO9001:2000. These documents are widely used as benchmarks for industry and government agencies throughout the world. To align the QMS with expectations of its clients, Q Pharma and its subsidiaries may also adopt and incorporate elements of ISO13485 and 21 CFR 211 and 820. 2.2.1
Quality Processes The primary processes Q Pharma employs to achieve its quality goals are listed in Sections 4 through 8 of this Quality System Manual, and are described in the following Quality System Process documents: Project Management Process (QSP-001) Quality Management Process (QSP-002) Management Responsibility Process (QSP-003) Resource Management Process (QSP-004) Analysis and Improvement Process (QSP-005) iPT Product Realization Process (QSP-006) CSSC Product Realization Process (QSP-007) Q Logistics Product Realization Process (QSP-008) • • • • • • • •
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TERMS AND DEFINITIONS
Contract Review A pre-defined process for reviewing and approving the terms of a Contract to ensure that it is appropriate to the organization and the task it applies to, sufficiently specific to ensure that its implementation will produce the desired results, and in compliance with regulatory and business requirements and guidelines. Deliverable The output of a Project, especially the specific, released documentation provided to the customer to demonstrate the outputs. ISO9001 The International Quality Standard, established by the International Organization for Standardization, defining a standardized and widely accepted Quality Management System. The Q Pharma Quality Management System is modeled after ISO9001:2000, which emphasizes tracking of customer satisfaction and improvement of customer perception based on meeting customer needs and requirements. Master Quality Organization Chart A list of key employees with specific responsibilities and authorities described in the Q Pharma Quality Management System. The Master Chart is a supplement to this Quality System Manual. Operation An ongoing process fulfilling a defined service to a customer. Like a Project, an Operation has defined processes to meet documented customer requirements, but Operations are not temporary. Operations Manager A manager charged with ensuring the performance of a customer fulfillment operation. Product The output Q Pharma provides to its customers: project activities and deliverables, drug distribution and records, and drug sample tracking and audit reports. Project A temporary endeavor undertaken to produce a defined set of outputs; see also Deliverable. Project Manager (PM) A manager with Project Management training and expertise, assigned to lead a Q Pharma Project. See also Project Representative .
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Project Representative A colleague responsible for interfacing and communicating with a client regarding a specific project or Statement of Work. When a Project Manager is assigned, the PM is usually also the Project Representative. Purchase Order (PO) Documentation of purchase requests and approvals. When an executed PO is accepted by a vendor, it constitutes a Contract and is therefore subject to Contract Review. Quality Management Policy (QMP) Controlled Documents that describes the overall Quality Management System, defining the major processes and policies for ensuring quality. Consisting of this Quality System Manual and its policy supplements, QMPs constitute the Q Pharma Tier 1 (top-level) document hierarchy. Quality Management System (QMS) The documented processes used by Q Pharma to identify customer needs, ensure that provided services fulfill those needs, and to provide the tools, metrics, and oversight necessary to continually improve processes and customer satisfaction. Quality Record Data, whether electronic, paper, or in other durable format, that provides evidence of conformance of a process with the Quality Management System. Quality Review Board (QRB) The group of Top Management charged with review and implementation of Corrective and Preventative Actions and oversight and improvement of the Q Pharma Quality Management System. Quality System Process (QSP) A Controlled Document that describes a major process within the Quality Management System. QSPs constitute the Tier 2 (high-level) document hierarchy. Restricted Document A document whose content is not under strict revision and approval control, but whose location and access is controlled for business reasons (primarily to simplify and standardize uniform access methods). Examples include Guides, Work Instructions, training courses, and general organization charts. Standard Operating Procedure (SOP) A Controlled Document that described a specific procedure within a major process; this includes Work Instructions , detailed descriptions of how to perform a task for a particular process or client. SOPs form the foundation of the Tier 3 (mid-level) document hierarchy.
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Tidbit
A communications tool used by Q Pharma, whereby training and informational e-mails are copied to a dedicated ‘Tidbit’ folder and are available for subsequent employees to review. Top Management Officers, Directors, and Business Unit Managers; those managers whose core responsibilities cannot be delegated. Validation In this document, Validation has three distinct meanings: The validation services CSSC provides to its clients Validation of internal processes and systems, e.g. the Q Pharma computer network Validation of iPT and Q Logistics practitioners (e.g. records of state licensing authorizing transfer of drug samples) • • •
4.
QUALITY MANAGEMENT SYSTEM
4.1
GENERAL REQUIREMENTS Q Pharma establishes, documents, implements, maintains, and continually improves a Quality Management System in accordance with the requirements of ISO 9001:2000. To implement its Quality Management System, Q Pharma: identifies the processes needed for the Quality Management System and their application throughout the organization; determines the sequence and interaction of these processes; determines criteria and methods required to ensure the effective operation and control of these processes; ensures the availability of resources and information necessary to support the operation and monitoring of these processes; monitors, measures, and analyzes these processes; and takes action necessary to achieve planned results and continual improvement. •
• •
•
• •
Q Pharma manages its processes in accordance with ISO9001:2000; see QSP-002, Quality Management Process. 4.2
DOCUMENTATION REQUIREMENTS Q Pharma subsidiaries develop, review, and control large numbers of documents on behalf of their clients. Such documents constitute the ultimate deliverable “product” produced by Q Pharma. Therefore, the development and control of such documents do not fall under Q Pharma document control procedures, but instead are handled under each respective subsidiary’s QSP for Product Realization. This section therefore deals with internal documentation describing and supporting the Q Pharma 2007 Q Pharma Inc. Unauthorized reproduction or distribution prohibited. CONTROLLED DOCUMENT
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Quality Management System. 4.2.1
General The Q Pharma Quality Management System includes: documented Quality Policies and Objectives (this Quality System Manual and supplements); documented procedures required by ISO 9001:2000; documents needed to ensure the effective planning, operation, and control of the processes identified in the Quality Management System; and records required by the Quality Management System. •
• •
•
The hierarchy of Controlled Documents is represented in the following diagram:
TIER 1 & I E S E S Quality L I C C T I V O P Management J E O B Policies & Supplements TIER 2 Quality System Processes
E S S S C E O P R
TIER 3 SOPs, WIs, Specifications, Protocols and Controlled Forms
S R E D U E O C P R
TIER 4 Training Materials, Employee Job Descriptions, Work Templates, Logs, Guides, Electronic Forms
E D I C T S T R E N T S R E C U M D O
QUALITY RECORDS Data, completed Forms, executed Protocols
4.2.2
Quality System Manual This Quality System Manual, including its supplements, is established to define: the scope of the Quality Management System, including exclusions (§1.3) from the regulatory requirements of ISO9001:2000; the major processes used in the Quality Management System, and the Quality System Procedures that describe them; and the interactions between the major processes of the Quality Management System; and the Quality Policies, Objectives, and Organization, establishing the quality goals and directives of Q Pharma Top Management. •
•
• •
This Quality System Manual may be supplemented by Quality Policy Supplements, which will describe policies, guidelines, and objectives for specific issues and designate personnel and authorities related to quality. The Quality System Manual is a public document; its Quality Policy Supplements are not.
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Control of Documents Documents required for the Quality Management System are identified and controlled per SOP-001, Generation and Control of Documents , which describes: review of documents for adequacy and approve them prior to issuance for use; revision of documents as needed; identification of specific individuals responsible for the review and approval of Controlled Documents, so that the review and approval is performed by persons with knowledge in and responsibility for the subject matter of the document; assurance that document revisions are identifiable to ensure that only current documents are distributed and used; ensuring that relevant documents are available at all locations where they are used or required, and that they are legible and readily identifiable; preventing the use of obsolete or rescinded documents; maintaining a history of revisions, approvals, and issuance of each Controlled Document; and instituting approval and control systems appropriate to the criticality of the document. • • •
•
•
• •
•
Controlled Documents are maintained by the Q Pharma Compliance Department; forms and protocols are a special type of document and are Controlled Documents until they are used, at which time they become Quality Records. Restricted Documents are those not required to be under full approval and control but for convenience still need to have centralized and limited access, such as Templates and Training Materials, or which provide recommended or example directions supplementing a controlled procedure, such as a Guide. Restricted Documents are revised and maintained by the applicable Q Pharma subsidiary and department, and may optionally be published by the Q Pharma Compliance Department for convenience. 4.2.4
Control of Quality Records Quality Records are kept to provide evidence of conformity to the requirements and effective operation of the Quality Management System. Quality Records are to be legible, identifiable, and retrievable for a predetermined period of time; requirements for the identification, storage, retrieval, retention, and disposition of Quality Records are defined in QMP-004, Document and Data Control Policy, and further described in procedures for each Q Pharma subsidiary. Records resulting from services provided to clients, and not directly documenting or implementing the Quality Management System, are considered Customer Property for the purposes of this Manual and are described in §7.5.4.
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MANAGEMENT RESPONSIBILITY
5.1
MANAGEMENT COMMITMENT
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Q Pharma provides evidence of commitment to developing and implementing the Quality Management System through the following methods:
5.2
5.1.1
Top Management communicates to personnel at all levels the importance of meeting customer and regulatory requirements. Such communications include training, employee meetings, and the company newsletter.
5.1.2
The President establishes the Quality Policy and Quality Objectives in QMP-002 per §5.3 and 5.4.1.
5.1.3
The Quality Review Board conduct management reviews per §5.6.
5.1.4
Business Unit Managers ensure the availability of necessary resources by forecasting and reviewing workloads per QSP-004, Resource Management Process.
CUSTOMER FOCUS Each subsidiary’s Business Unit Manager ensures that customer needs and expectations are determined per each subsidiary’s Product Realization Process, translated into requirements, and met with the aim of achieving customer satisfaction per §7.2.1 and 8.2.1.
5.3
QUALITY POLICY The President of Q Pharma defines and approves QMP-002, Quality Policy and Objectives . QMP-002 considers: the purpose of Q Pharma’s business and the need for policies and objectives to be appropriate to that purpose; the need to be committed to meeting requirements of, and continuous improvement of, the Quality Management System; the need to provide a framework for establishing and reviewing Quality Objectives; the means by which Quality Policies and Quality Objectives are to be elaborated into goals for each subsidiary; the need to be communicated and understood within the company; and the need to be reviewed and, when necessary, modified for continuing pertinence. •
•
• •
• •
The Quality Policy is a Tier 1 Controlled Document and will be available to all colleagues.
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PLANNING 5.4.1
Quality Objectives In establishing Quality Objectives, the President of Q Pharma ensures that they are measurable, consistent with the Quality Policy, and reflect a commitment to continual improvement. Quality Objectives, and progress in meeting those objectives, are reviewed as part of Management Review.
5.4.2
Quality Management System Planning Q Pharma’s Quality Plan is documented in and implemented through the Quality Management System. The Management Representative ensures that changes to the Quality Plan are conducted in a controlled manner to ensure the integrity of the Quality Management System.
5.5
RESPONSIBILITY, AUTHORITY, AND COMMUNICATIONS 5.5.1
Responsibility and Authority The Q Pharma Master Quality Organization Chart is an attachment to this Quality System Manual. It identifies major functions and cross-functions within Q Pharma and identifies the managers responsible for each. Other organization charts may exist with more or less detail, for example complete listings of all employees and their reporting structure, but they must not contradict the Master Chart. The Master Quality Organization Chart is referenced within various Controlled Documents to define who has specific responsibility for tasks, reviews, and approvals with the Quality Management System. The Master Quality Organization Chart is a Quality Record approved by the President. Copies will be made available to all colleagues. •
•
•
5.5.2
Management Representative The President of Q Pharma appoints the Management Representative who, irrespective of other duties, has responsibility and authority for: ensuring that processes of the Quality Management System are established, implemented, and maintained; reporting to Top Management on the performance of the Quality Management System, including needs and opportunities for improvement; ensuring the promotion of customer requirements throughout the organization; and acting as liaison with external parties on matters relating to the QMS. •
•
• •
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Quality Review Board (QRB) Management review of the Quality Management System is conducted by the Q Pharma Quality Review Board, consisting of the President, Management Representative, Business Unit Managers, Compliance Manager, and for issues impacting company finances or information systems, the CFO and/or CIO. More than one position may be filled by a single individual as specified by this Quality System Manual. QRB is led by the President or other designated independent manager and is responsible for: reviewing and resolving identified Corrective and Preventative Actions; establishing and tracking company quality policy and objectives; determining and providing resources based on Business Unit Manager input; reviewing and making improvements to the Quality Management System; ensuring that Customer Expectations are being met; and follow-up on previous QRB actions to ensure that decisions are being effectively implemented. • • • • • •
The QRB will meet at least annually. Interim QRB meetings may also be held as appropriate to assure ongoing corrective actions or in conjunction with other management meetings, e.g. resource allocation or staff meetings; such meetings do not require formal documentation. The Management Representative shall establish agendas for QRB meetings and maintain records of discussions, plans, actions, and follow-up. 5.5.4
Internal Communications The President identifies communications processes to ensure effective communications of the Quality Management System, including quality plans, objectives, and changes.
5.6
MANAGEMENT REVIEW 5.6.1
General The Top Management of Q Pharma will review the Quality Management System to ensure its continuing suitability, adequacy, and effectiveness. This review will be held at least annually, with new Quality Objectives established annually. Records of these reviews shall be maintained by the Management Representative.
5.6.2
Review Inputs Management will review the following: audit results, including internal audits, customer or third party audits, project reviews, and audits by any regulatory bodies; customer feedback, including complaints, surveys, and customer communications; performance and conformity metrics; Corrective and Preventive Actions; •
• • •
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follow-ups to past Management Reviews; employee suggestions; and other recommendations for improvement.
Review Outputs The outputs from Management review are decisions and actions related to: improvements of the Quality Management System and its processes; improvements in the quality of Q Pharma services and deliverables; and changes in resource allocations. • • •
6.
RESOURCE MANAGEMENT
6.1
PROVISION OF RESOURCES Management of each Q Pharma subsidiary regularly reviews resource needs based on projected workload. The necessary organizational resources are provided to implement and maintain the Quality Management System and its effectiveness and enhance customer satisfaction. The VicePresident of Project Management assists in identifying and recruiting qualified personnel, and during management review, Top Management evaluates the need to adjust resource levels to accommodate quality issues and business strategy; see QSP-004, Resource Management Process .
6.2
HUMAN RESOURCES 6.2.1
General Personnel performing work affecting quality shall be competent on the basis of applicable education, training, skills, and experience.
6.2.2
Competence, Awareness, and Training This Quality System Manual defines roles and duties for Q Pharma Top Management. Other positions within the company whose performance affects quality are defined through Job Descriptions. Q Pharma: identifies competency needs by evaluating the duties defined in Job Descriptions; provides training to satisfy those needs; measures the effectiveness of the actions taken through testing and evaluation of job performance; ensures that colleagues are aware of the relevance and importance of their activities and how they contribute to the achievement of Quality Objectives; and maintains records of education, training, skills, and experience. • • •
•
•
6.2.3
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Q Pharma does not maintain a dedicated Personnel department but outsources those functions to a third-party Human Resources vendor. Permanent employees must follow policies of both the third-party HR vendor and Q Pharma; contract employees are subject only to Q Pharma policies. 6.3
6.4
INFRASTRUCTURE 6.3.1
The Chief Information Officer determines, provides, and maintains infrastructure related to process equipment (hardware and software) and supporting services such as communications.
6.3.2
For personnel based in permanent facilities (Morristown and Florham Park, NJ), Q Pharma Top Management determines the needs for and approves buildings, workspace, and associated utilities. Actual procurement, installation, and maintenance of infrastructure are the responsibility of external services under the direction of Q Pharma or subsidiary management.
WORK ENVIRONMENT 6.4.1
Review Annual reviews of the Quality Management System will include an evaluation of the work environment, its adequacy, and opportunities for improvement, including Infrastructure Health and Safety Housekeeping Work ethics • • • •
6.4.2
Safety The Q Pharma Compliance Manager has overall responsibility for maintaining a safe work environment and correcting unsafe conditions and practices, and acts as the central point of contact for compliance with government and regulatory agencies on safety matters.
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Client Sites Except as otherwise noted in QMP-005, Consultant and Contractor Policy , and QMP003, Safety Policy Manual , infrastructure and responsibility for safety at client sites rests with client representatives. Each colleague is required to adhere to safety instructions and guidelines established by Q Pharma clients.
6.4.4
Remote Offices Regional Directors are responsible for infrastructure and safety at their locations.
7.
PRODUCT REALIZATION Q Pharma subsidiaries are service companies; they do not design or manufacture any material goods. Q Pharma’s product is the training, systems design, validation, drug distribution, sample accountability, and other efforts and expertise it provides and especially the documentation it delivers. Product Realization therefore focuses on the processes Q Pharma employs to determine customer needs, provide the services necessary to fulfill customer needs, and formally document that effort and its result; see the Product Realization Process QSP specific to each subsidiary.
7.1
PLANNING OF PRODUCT REALIZATION PROCESSES Q Pharma subsidiaries plan and develop processes needed for product and deliverables realization. Planning of these processes is consistent with the Q Pharma Quality Management System. In planning these processes, Q Pharma subsidiaries determine, as appropriate: quality objectives and deliverables requirements; the need to establish processes and documentation, and provide resources specific to the project or operation; verification, monitoring, and evaluation activities, specific to the project or operation and the criteria for deliverables acceptance; and records necessary to demonstrate that the realization of processes and the resulting output meet requirements. • •
•
•
7.2
CUSTOMER-RELATED PROCESSES 7.2.1
Determination of Customer Requirements Each subsidiary of Q Pharma determines: requirements specified by the customer, including requirements for delivery; requirements not specified by the customer, but necessary for the customer’s stated intended use; and statutory and regulatory requirements. • •
•
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The role Q Pharma plays in these activities varies from customer to customer, and is overseen by Q Pharma sales and the pertinent Business Unit Manager. Q Pharma policies shall determine the criteria to identify and document the customer’s expectations regarding the extent to which Q Pharma is responsible for determining deliverables requirements; see QPM-005, Consultant and Contractor Policy . 7.2.2
Review of Customer Requirements Q Pharma reviews customer requirements and conducts contract review prior to the commitment to provide services (e.g., submission of proposals, acceptance of contracts, agreeing to project changes) and ensures that: project, operations, and deliverables requirements are clearly defined; contract requirements differing from those previously expressed (e.g. work outside that described in a proposal) are resolved; and Q Pharma has the ability to meet the stated requirements. • •
•
When customer requirements are changed, Q Pharma ensures that relevant documentation is changed (e.g., through written change notices). Q Pharma communicates changes to relevant personnel to ensure that they have been made aware of the changed requirements. 7.2.3
Customer Communications Q Pharma determines and implements effective arrangements for communication with customers in relation to: project and operational progress, issues, and status; inquiries and contracts; changes, including the projected need for changes; and customer feedback, including customer complaints. • • • •
Q Pharma encourages and utilizes unsolicited feedback from customers by providing contact information through its status reports, proposals, and web site. 7.3
DESIGN AND DEVELOPMENT Q Pharma is primarily a project-oriented company; whether writing validation protocols at CSSC, preparing to receive drug products from a new client at Q Logistics, or designing a database interface at iPT, both new and changed processes are treated as a development project with defined scope, inputs, outputs, and verifications unless the customer contractually specifies otherwise.
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Design and Development Planning Q Pharma plans and controls the development of its project activities, operations, and documentation deliverables and determines: development processes and schedules; appropriate review and verification activities; and responsibilities for activities. • • •
Note: The extent of development planning to be employed is commensurate with project complexity and Q Pharma’s defined role per §7.2.1.
Interfaces between different planning teams (e.g., Q Pharma team and client team) are managed by Project Managers or Project Representatives to ensure effective communication and clarity of responsibilities. Planning output is updated as the project progresses. 7.3.2
Design and Development Inputs Inputs relating to project and deliverables requirements are defined and documented per each subsidiaries relevant product realization process. These include: required skills and experience of the team; functional and performance requirements of client systems undergoing development or validation (as applicable); milestones and other expectations mandated by the client; regulatory and legal requirements, when appropriate per §7.2.1; applicable information derived from previous similar projects; and any other requirements essential for project development. • •
• • • •
Sales and the Business Unit Manager (or as delegated to the assigned Project Manager or Representative) review inputs for adequacy and work to resolved incomplete, ambiguous, or conflicting requirements throughout the project, from proposal and contract through initiation and changes. 7.3.3
Design and Development Outputs Outputs of project development activities are documented in the form of project plans to enable verification that inputs have been met. These outputs assure that projects: meet the input requirements; provide appropriate information for operations; and contain or reference acceptance criteria to identify that deliverables and milestones have been met. • • •
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Design and Development Review The extent of reviews is commensurate with project complexity. For small projects, the Project Representative’s assessment of progress and issues on the project status report may be sufficient, where larger projects require scheduled review with team participation and formal minutes.
7.3.5
Development Verification Verification of project development is performed for each project to ensure that the outputs meet the inputs. Verification activities include: comparison of project activities to baseline cost and schedule estimates or mandates; evaluation of project deliverables for adequacy and conformance to inputs; and customer review and feedback. • • •
The results of this verification are recorded. 7.3.6
Project Completion Each Q Pharma subsidiary will define the process for completing a design and development project. For example, a CSSC validation project is synonymous with the development project, both of which end when the final contracted document is delivered; while an iPT development project generally ends with the transfer of a new client, system, or process into routine, ongoing services supporting client operations.
7.3.7
Change Control Changes to development project and ongoing operational services scope are identified, documented, and controlled through a formal change notification process defined in the pertinent subsidiary’s Product Realization QSP. Changes are verified and approved prior to implementation, including necessary contract reviews. Records of changes and resulting necessary actions are maintained.
7.4
PURCHASING Q Pharma does not manufacture products or provide services that typically require rigorous purchasing requirements. This section applies to those products and services for which a clear impact upon the quality of Q Pharma’s services has been identified. For example, components ordered for a validated computer network will require a higher level of scrutiny. The basic purchasing instrument employed at Q Pharma is the Purchase Order, which is processed electronically. It is used primarily for business purposes, to simplify and expedite ordering and make approving managers accountable for disbursement of company funds. A key 2007 Q Pharma Inc. Unauthorized reproduction or distribution prohibited. CONTROLLED DOCUMENT
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use of Purchase Orders is to evaluate and hire short-term specialist contractors. Contractors hired for routine operational work (e.g. keypunchers) are typically hired through a temporary employment agency. 7.4.1
Purchasing Processes Q Pharma has established purchasing processes to ensure purchased materials and services conforms to requirements. For critical products, Q Pharma: evaluates and selects suppliers based on their ability to supply product in accordance with Q Pharma requirements; reevaluates suppliers based on their previously demonstrated cost, capabilities, and performance; and defines the type and extent of control to be exercised depending upon the potential impact on the quality of Q Pharma’s services. •
•
•
7.4.2
Purchasing Information Purchasing documents contain information describing the goods and services to be purchased, including where appropriate requirements for approval of equipment prior to installation or deployment. Approving managers and the Q Pharma Purchasing Manager ensure the adequacy of specified requirements prior to Purchase Order approval.
7.4.3
Verification of Purchased Products Purchased products are verified upon receipt against Purchase Order requirements, and mistakes and ambiguities resolved. Procedures exist to track problems with received goods and services and to establish metrics to assist in management reviews of vendor performance. When the quality of Q Pharma’s services is potentially impacted by the purchased product, detailed verification procedures will be specified either as part of the Purchase Order or any Control Notification required to deploy the equipment (e.g., introducing computerized equipment into a validated system), as appropriate.
7.5
SERVICE PROVISION 7.5.1
Control of Service Provision Q Pharma provides services under controlled conditions including, as appropriate: information that describes the key characteristics of outputs and deliverables; availability of adequate written procedures; suitable equipment, including data/word processing and communications systems; project and operations monitoring and evaluation tools and processes; and defined processes for conducting validation, sample tracking, warehousing, and other • • • • •
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primary project categories, including review and release of deliverables. 7.5.2
Validation of Service Provision Processes Q Pharma validates processes where the resulting output is not verified by subsequent inspection and monitoring. Q Pharma policies shall identify processes subject to validation and general requirements; written plans shall document the scope of validation and define success in terms of predetermined objectives and parameters.
7.5.3
Identification and Traceability Q Pharma identifies products by unique tracking numbers and tracks the drafting, editing, review, revision, and release of deliverables through unique revision numbering; identification of physical materials such as drug product is performed by a combination of Q Pharma-generated tracking numbers and product identification provided by the client. The identification of client deliverables are separate from the systems used to identify and track internal quality documents to preclude mix-ups between the two.
7.5.4
Customer Property The customer property Q Pharma is most involved with is intellectual property; Q Pharma may be privy to or in possession of customer plans, specifications, strategies, designs, and other highly confidential materials. Q Pharma takes every reasonable precaution to safeguard customer property and defines Q Pharma obligations regarding intellectual property in its proposals and, where appropriate, separate Confidentiality Agreements. Generally, customer property is returned to the client at the conclusion of a project unless agreed otherwise. Other types of Customer Property include: Drug product, samples, and marketing materials provided by the customer for distribution and tracking by Q Logistics. Q Logistics provides both physical and procedural safeguards to ensure that property can only be accessed and dispositioned by authorized personnel. Equipment owned by the client, used by CSSC personnel in the conduct of client projects (e.g. metrology equipment). Such equipment may be located at client sites or Q Pharma facilities during the course of the project. CSSC colleagues shall follow client policies and procedures whenever using such equipment and exercise exceptional care and control over such materials to avoid loss and damage, including taking appropriate physical security measures. Paper and electronic records provided by a client, used by iPT to track, audit, and report on client representative’s inventory and regulatory compliance. Such records are stored to preclude unauthorized loss, damage, and alteration and to provide expedient and accurate retrieval. •
•
•
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In the event that Q Logistics should be contracted to handle controlled substances, a separate operation plan shall be developed and executed to identify and fulfill all requirements for product safekeeping and tracking. 7.5.5
Preservation of Product When Q Pharma provides products to clients, they shall be uniquely identified to preclude mix-ups with other products or previous revisions. Control numbering shall be employed that positively identifies products that have been formally released to the client. Where the client does not provide or dictate control numbering, Q Pharma subsidiaries shall have procedures for generating and tracking control numbers internally. Q Logistics drug inventory shall be stored under stated environmental conditions, demonstrated by ongoing monitoring and, where appropriate, environmental qualification. Q Logistics procedures shall specify the steps and notifications necessary when Out of Specification conditions occur.
7.5.6
Control of Monitoring and Measuring Equipment Q Pharma does not maintain metrology devices for use in client validation projects. Q Logistics does maintain calibrated equipment for environmental monitoring of controlled environments to ensure conformance with customer requirements, but such equipment is calibrated and checked by outside laboratories. Q Pharma may keep an inventory of metrology equipment for use client projects, but such equipment is not generally maintained in a ready-to-use state. Where a client prefers to use Q Pharma equipment, the proposal (or subsequent change order) shall specify the equipment and the terms for returning the equipment to useable status.
8.
MEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.1
GENERAL Q Pharma defines, plans, and implements monitoring, analysis, and improvement processes to assure conformity of services and deliverables with client expectations and achieve continual improvement of its services and the Quality Management System. This includes the determination and use of applicable metrics and methodologies; see QSP-005, Analysis and Improvement Process.
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8.2
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MONITORING AND MEASURING 8.2.1
Customer Satisfaction Q Pharma monitors information relating to customer perception of Q Pharma subsidiaries (as regards to meeting their requirements) as a primary measure of Quality Management System performance. Customer satisfaction is evaluated through two separate lines of responsibilities: The cognizant project or operations manager has direct responsibility for tracking customer satisfaction and managing client expectations for projects and operations under their charge. Each Business Unit Manager takes personal responsibility for reviewing and improving customer perception and maintaining and improving client relationships. While specific tasks may be delegated to individuals, the Business Unit Manager cannot delegate overall responsibility. •
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8.2.2
Internal Audits Q Pharma conducts internal audits to determine whether the Quality Management System conforms to the requirements of ISO9001:2000 and is effectively implemented and maintained. Q Pharma develops the audit plan annually, taking into account the status and importance of the activities to be audited and the results of previous audits. The audit plan is reviewed after each audit and updated if needed. The internal audits: shall have defined criteria, scope, frequency, and methods, where appropriate; must be performed by personnel other than those who have direct responsibility for the activity being audited; are reviewed by Top Management, who assign appropriate follow-up actions and determine if previous follow-ups have been effective in remediation of deficiencies identified during previous audits; and are to be followed by timely corrective actions and verification that corrective actions were implemented. • •
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Responsibilities and activities for internal audits and the identification and implementation of corrective actions are conducted per QSP-005. 8.2.3
Monitoring and Measurement of Processes Q Pharma applies suitable methods for monitoring of Quality Management System processes. These methods demonstrate the ability of processes to achieve planned results. Corrective actions are taken when planned results are not achieved to ensure continued project and operational conformity with requirements. 2007 Q Pharma Inc. Unauthorized reproduction or distribution prohibited.
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8.2.4
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Monitoring and Measurement of Product Each Q Pharma subsidiary reviews product against customer, industry, and regulatory requirements, including best practices and regulatory agency expectations, to verify that requirements for deliverables are met. These Quality Control reviews are conducted by the pertinent subsidiary Business Unit Manager or Regional Director (or, more typically, delegated to a qualified manager or dedicated quality resource). Records are maintained documenting reviews and the authority responsible for release to customers. Deliverables may not be released until all specified activities have been satisfactorily completed, unless otherwise approved and authorized by the customer. The level of verification and depth of review is commensurate with Q Pharma’s defined role as per §7.2.1. •
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8.2.5
Control of Nonconforming Product Q Pharma ensures that products that do not conform to requirements are uniquely identified and controlled to prevent unintended release to customer. Where premature distribution of incomplete deliverables is necessary in order for the client to answer questions or facilitate discussion, procedures shall dictate means of controlling and uniquely identifying deliverables as such to preclude mix-ups. Non-conforming products are corrected and subject to re-verification to demonstrate conformity to requirements. Where authorized in writing by a customer, Q Pharma subsidiaries may accept or release nonconforming product through a formal concession process (e.g. a Material Review Board).
8.2.6
Analysis of Data Q Pharma determines, collects, and analyzes appropriate metrics to determine the suitability and effectiveness of the Quality Management System and to identify improvements that can be made. This includes data generated by monitoring activities and other relevant sources to provide information concerning: customer satisfaction, especially perception of meeting requirements; conformity of product and deliverables to requirements and the amount of corrective actions required; trends of processes, including opportunities for preventative actions; and supplier performance. • •
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2007 Q Pharma Inc. Unauthorized reproduction or distribution prohibited. CONTROLLED DOCUMENT
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8.3
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IMPROVEMENT 8.3.1
Continual Improvement
Q Pharma improves the effectiveness of the Quality Management System through the use of the Quality Policy and Objectives, audit results, analysis of data, Corrective and Preventative Actions, and Management Review per QSP-005, Analysis and Improvement Process . Note: As authorized in §1.3, Q Pharma does not consider Corrective Actions and Preventive Actions as separate processes, but rather handles both through a single Corrective and Preventive Action process. 8.3.2
Corrective Action Q Pharma takes corrective action to avoid and eliminate the cause of nonconformities in project deliverables, customer product, and Quality Management System processes. Procedures for corrective action define requirements for: reviewing nonconformities, including customer complaints; determining the cause of nonconformities; evaluating the need for actions to ensure that nonconformities do not recur, including training; determining and implementing the appropriate corrective actions; recording the results of actions taken; and management review of corrective actions. • • •
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8.3.3
Preventive Action Q Pharma identifies appropriate preventive actions to avoid and eliminate the causes of potential nonconformities to preclude occurrence. Procedures for preventive actions define requirements for: determination of potential nonconformities; evaluating the need for actions to prevent occurrence of nonconformities; determining and implementing actions needed; recording results of actions taken; and management review of preventive actions. • • • • •
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