GMP Manual
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GMP MANUAL Contents
GMP MANUAL Contents Pharmaceutical Quality System (PQS)
1.A
Preface
1.B
The road to a Pharmaceutical Quality System
1.C 1.C.1 1.C.2
Introduction to the PQS General requirements Documentation
1.D 1.D.1 1.D.2 1.D.3 1.D.4
Main elements of a PQS Management responsibility Resource management Manufacturing operations Evaluation activities
1.E 1.E.1 1.E.2 1.E.3 1.E.4
Essentials of a PQS Principles of a process Process mapping Responsibilities Key Performance Indicators (KPIs)
1.F 1.F.1 1.F.2 1.F.3 1.F.4
Practical implementation of a PQS Assistance for implementation Organizational aspects Process of developing documents Document hierarchy
1.G
Structure of a PQS quality manual – example
1.H
Correlation between GMP requirements (WHO) and ISO 9001:2000
1.I
References
2
Personnel
2.A
Place of work and job descriptions
2.B 2.B.1 2.B.2
Requirements of the personnel Qualification requirements Health requirements
Contents
1
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2.C 2.C.1 2.C.2 2.C.3 2.C.4 2.C.5 2.C.6 2.C.7 2.C.8
Training Purpose of training Responsibility for training Requirements profiles/learning objectives Training contents and target groups Training planning Carrying out Reviewing the training and the training system Documentation
2.D 2.D.1 2.D.2 2.D.3 2.D.4 2.D.5 2.D.6
Function owners subject to public law Qualified Person (QP) Head of Production Head of Quality Control Qualified Person in Accordance with Article 103 of Guideline 2001/83/EC Scientific Service in Charge of Information Medical sales representatives
3
Premises
3.A 3.A.1 3.A.2 3.A.3 3.A.4 3.A.5 3.A.6
Official Requirements Location, connection to other rooms Size, area, height Installation and supply of utilities Lighting, ventilation, air-conditioning Hygienic construction Room book and layout
3.B 3.B.1 3.B.2 3.B.3 3.B.4
Material flow, personnel flow and layout Material flow Personnel flow Layout Design concepts in FDA’s Sterile Drug Products Produced by Aseptic Processing guideline
3.C 3.C.1 3.C.2 3.C.3 3.C.4 3.C.5 3.C.6 3.C.7
Room classes General GMP Requirements for Premises GMP Requirements for Cleanrooms: Air Cleanliness Grades Corresponding FDA Determinations GMP Requirements for Premises Room-specific Allocation of Air Cleanliness Stipulations Cleanliness Zoning Concepts Converting GMP Stipulations into Reality
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3.D 3.D.1 3.D.2 3.D.3 3.D.4
Construction elements Walls Doors and windows Floors Ceilings
3.E 3.E.1 3.E.2 3.E.3 3.E.4
Barrier systems and isolators Protection concepts for maximized sterility assurance Pharmaceutical isolator technology Restricted access barrier systems (RABS technology) Application options for RABS and isolators
3.F 3.F.1 3.F.2 3.F.3 3.F.4 3.F.5
Building services Basic requirements for installation Heating Sanitary plumbing and sewage Electrical installations incl. IT-management and control systems Qualification
3.G 3.G.1 3.G.2 3.G.3 3.G.4 3.G.5 3.G.6
Heating Ventilation Air Conditioning (HVAC) Introduction Room ventilation systems Filters Principles for the design and planning of air conditioning ventilation systems Design criteria for the ventilation of premises Maintenance of air ventilation systems
3.H 3.H.1 3.H.2 3.H.3 3.H.4
Process Gases Quality Requirements Generation, Storage and Distribution System design Qualification and monitoring
3.I 3.I.1 3.I.2 3.I.3 3.I.4 3.I.5 3.I.6 3.I.7 3.I.8
Qualification of premises and air-conditioning systems Objectives of qualification Regulatory and normative fundamentals of qualification Project development and qualification Qualification Master Plan Qualification Plans and Qualification Reports Qualification checklists Requirements for measurement and test reports Requalification
3.J 3.J.1 3.J.2 3.J.3
Monitoring of HVAC systems Objectives of process monitoring Data management stipulations Air cleanliness and other room air data GMP Manual (Up14) © Maas & Peither AG – GMP Publishing
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3.J.4 3.J.5 3.J.6
Risks of microbiological monitoring Alarm and action limits Operation and maintenance
3.K
References
4
Facilities and Equipment
4.A
Introduction
4.B 4.B.1 4.B.2 4.B.3
Mechanical components Construction and installation materials GMP-compliant design characteristics Electrical and pneumatic components
4.C
Control
4.D 4.D.1 4.D.2 4.D.3
Facility concepts CIP (Cleaning in Place) Isolator technology Connected facilities
4.E 4.E.1 4.E.2 4.E.3
Examples of facility qualification, Design qualification Installation qualification Operational qualification
4.F 4.F.1 4.F.2 4.F.3 4.F.4
Technical documentation Necessity Scope and content Administration of the technical documentation Log book
4.G 4.G.1 4.G.2 4.G.3 4.G.4
Calibration Definitions Procedure Documentation Administration of scheduled calibration dates/ times
4.H 4.H.1 4.H.2 4.H.3
Maintenance Types of maintenance GMP-conforming maintenance Systems for maintenance
4.I 4.I.1 4.I.2 4.I.3 4.I.4
CIP (Cleaning in Place) Introduction CIP systems GMP-conforming design of CIP facilities Nozzle heads for container cleaning
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4.I.5 4.I.6
Measuring technology Realisation of cleaning systems
4.J 4.J.1 4.J.2 4.J.3 4.J.4 4.J.5 4.J.6 4.J.7 4.J.8 4.J.9 4.J.10 4.J.11
Containment (personnel protection) in solids handling Significance Definition of terms Containment grades of products Measurement of the residue limits (OEL) Example of containment facility planning Containment weak points Containment systems for filling and emptying drums Container systems Filter systems Sampling Containment on equipment
4.K 4.K.1 4.K.2 4.K.3 4.K.4 4.K.5
Process control systems Definitions Features of process control systems How to use process control systems Carrying out a process control system project Qualification of process control systems
4.L 4.L.1 4.L.2 4.L.3 4.L.4 4.L.5 4.L.6 4.L.7 4.L.8 4.L.9
Hygienic (sanitary) design when using solids Introduction Surfaces Material: stainless steel Connections Hoists and roller conveyors Pneumatic conveyor system Dosing systems Platforms and stands Clean room installations
5
Pharmaceutical Water
5.A 5.A.1 5.A.2 5.A.3 5.A.4
Water types Potable water Purified water Highly purified water Water for injection
5.B 5.B.1 5.B.2 5.B.3
Generation of pharmaceutical water Purified water (PW) Water for injection (WFI) Purification of pharmaceutical water treatment systems GMP Manual (Up14) © Maas & Peither AG – GMP Publishing
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5.C 5.C.1 5.C.2 5.C.3 5.C.4 5.C.5 5.C.6 5.C.7
Distribution and storage of pharmaceutical water Loop Fixtures Measuring technique Formation of biofilms Rouging Buffering of ultra pure water Loop with subloops
5.D 5.D.1 5.D.2 5.D.3 5.D.4 5.D.5 5.D.6 5.D.7 5.D.8
Qualification of water supplies Introduction Risk analysis Design qualification Installation qualification Operational qualification (OQ) Transfer to the user Process validation/performance qualification (PQ) Qualification report
5.E 5.E.1 5.E.2 5.E.3 5.E.4 5.E.5 5.E.6
Operation of water supplies Procedures to reduce microbial counts Maintenance of a water supply Calibration of measuring systems Change control Requalification Decommissioning/uninstalling
5.F 5.F.1 5.F.2 5.F.3 5.F.4
Pure steam systems Physical principles Quality requirements for pure steam Pure steam generation Pure steam distribution system
6
Qualification
6.A 6.A.1 6.A.2 6.A.3 6.A.4 6.A.5 6.A.6 6.A.7 6.A.8
Official requirements Legal aspects of qualification Documentation of the qualification Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Qualification of established facilities Requalification
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Preparation of the qualification Commissioning Sequence Qualification team Responsibilities Qualification by external service providers Risk analysis
6.C 6.C.1 6.C.2 6.C.3 6.C.4 6.C.5
Qualification documentation Qualification master plan Qualification plan Qualification report Labeling of the qualification status SOP – “Qualification of facilities and equipment”
6.D 6.D.1 6.D.2
Design qualification (DQ) User requirements (user specifications) Technical specification
6.E 6.E.1 6.E.2
Installation qualification (IQ) Examples of IQ plans Example: Fluid bed equipment
6.F 6.F.1 6.F.2
Operational qualification(OQ) Examples of OQ plans Example: Fluid bed dryer
6.G
Performance qualification (PQ)
6.H 6.H.1 6.H.2 6.H.3 6.H.4 6.H.5
Special cases of qualification Retrospective qualification Requalification Content of a review Maintenance of the qualified status Qualification of simple equipment
7
Process Validation
7.A 7.A.1 7.A.2 7.A.3 7.A.4 7.A.5
Official requirements Regulative aspects Principles of process validation Types of process validation Maintaining the validated status Documentation of process validation
7.B 7.B.1 7.B.2
Validation – a key element of quality management What is the significance of validation? How is validation defined?
Contents
6.B 6.B.1 6.B.2 6.B.3 6.B.4 6.B.5 6.B.6
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7.B.3 7.B.4 7.B.5 7.B.6 7.B.7
Who must perform validation? What faults can occur during validation? What are the benefits of validation? Current trends in process validation Process validation from the viewpoint of the FDA
7.C 7.C.1 7.C.2 7.C.3
Validation planning and procedure Process validation approaches Prerequisites and responsibilities Scope of Validation
7.D 7.D.1 7.D.2 7.D.3 7.D.4 7.D.5
Validation documentation Structure and archiving Validation master plan Validation protocol Validation report Documentation examples
7.E 7.E.1 7.E.2 7.E.3 7.E.4
Process Validation and Product Lifecycle Quality by Design Process Analytical Technology (PAT) Maintaining the validated state Process validation as a three-stage life cycle model
7.F
References
8
Cleaning Validation
8.A
Official requirements
8.B 8.B.1 8.B.2 8.B.3
How to validate cleaning procedures Optimization of cleaning procedures Compilation of cleaning instructions Validating manual and automated cleaning procedures
8.C
Cleaning validation master plan
8.D 8.D.1 8.D.2
Establishing the scope of validation Bracketing: determination of critical substances Matrixing: determination of equipment-specific validation protocols
8.E 8.E.1 8.E.2 8.E.3
Acceptance criteria and limit calculation Calculation of active pharmaceutical ingredient residues Calculation of cleansing agent residues Determination of the microbial status
8.F 8.F.1 8.F.2
Sampling procedures Swab test Rinse test
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8.F.3 8.F.4 8.F.5
Other procedures Selection of the appropriate sampling procedure Microbiological testing of surfaces
8.G 8.G.1 8.G.2
Analytical procedures Requirements for method validation Selection of the appropriate analytical procedure
8.H 8.H.1 8.H.2 8.H.3
Documentation Validation protocol Validation report Other documents
8.I 8.I.1 8.I.2 8.I.3 8.I.4 8.I.5
Maintenance of the validated status Changes and deviations Change control Revalidation New products and equipment Deviations
8.J
Cleaning validation documentation (example)
8.K
References
9
Computer System Validation
9.A
Introduction and terminology
9.B 9.B.1 9.B.2 9.B.3 9.B.4 9.B.5
Legal aspects Europe USA PIC/S Electronic signatures and electronic records ISPE GAMP® 5 – Good Automated Manufacturing Practice
9.C 9.C.1 9.C.2 9.C.3
System life cycle The “V model” Software development Configuration and customisation
9.D 9.D.1 9.D.2
System classification and risk management System classification according to ISPE GAMP®5 Risk management
9.E 9.E.1 9.E.2 9.E.3 9.E.4
Validation of computerised systems Validation organisation Validation plan Specifications (user requirements/technical specification) Unit, integration, system and acceptance tests GMP Manual (Up14) © Maas & Peither AG – GMP Publishing
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9.E.5 9.E.6 9.E.7 9.E.8
Validation report Data migration and start-up Examples Retrospective validation
9.F 9.F.1 9.F.2 9.F.3 9.F.4 9.F.5 9.F.6 9.F.7 9.F.8 9.F.9
Operation of computerised systems System description User training Standard operating procedures (SOPs) Access and security Data backup and archiving Contingency plans Change management and error reporting Periodic review Retirement of computerised systems
9.G 9.G.1 9.G.2 9.G.3
External service providers Relocation of activities Service level agreement Auditing of suppliers and service providers
9.H
References
10
Considerations on Risk Management
10.A 10.A.1 10.A.2 10.A.3 10.A.4 10.A.5 10.A.6
Introduction and Principles Advantages of Risk Management Considerations on the Risk-Based Approach Regulatory Environment Objectives Science-Based Approach Summary
10.B
Basic Consideration on Implementing Risk Management Into a Process Areas of Hazards Prerequisites Use of Knowledge and Experience Consideration on Manual Operations Elements of Risk Management Implementation of a Risk Management Process Commitment of Management Project Team Analysis of Existing Risk Management Approaches Standardization of Methods and Tools Considerations on Risk Based Behavior Additional Training Required?
10.B.1 10.B.2 10.B.3 10.B.4 10.B.5 10.B.6 10.B.7 10.B.8 10.B.9 10.B.10 10.B.11 10.B.12
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10.C 10.C.1 10.C.2 10.C.3 10.C.4 10.C.5 10.C.6
Details on Using Risk Management Principles as Behavior Application to the QM System The Team Assessment Criteria Procedure to Determine Conclusions Evaluation on Individual Topics (Detailed Evaluation) Using Risk Management Example on Process Validation
10.D
Methodologies to be Used to Facilitate Risk Management
10.E
Using Process Mapping
10.F 10.F.1 10.F.2
Using a Fishbone Diagram Create a Fish Bone Diagram Advantages and Disadvantages
10.G
Informal Use of Risk Management
10.H 10.H.1 10.H.2 10.H.3 10.H.4 10.H.5 10.H.6
Fault Tree Analysis (FTA) Basic Principles Objective: What a FTA Can Do and Where to Use It How to Run the Process of a FTA Prerequisites for an FTA Execution of an FTA Advantages and Disadvantages of an FTA
10.I 10.I.1 10.I.2 10.I.3 10.I.4 10.I.5
Failure Mode Effects Analysis (FMEA) Objectives and Areas of Application General Items on the FMEA Process Implementation of FMEA in a Project Advantages and Disadvantages of an FMEA Application Example of a Modified FMEA
10.J 10.J.1 10.J.2 10.J.3
Hazard Analysis of Critical Control Points (HACCP) Prerequisite and Result to be Expected Advantages and Disadvantages Application Example
10.K
Conclusion
11
Production
11.A 11.A.1 11.A.2 11.A.3
Sanitation Organisational prerequisites Sources of contamination Responsibilities and implementation
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11.B 11.B.1 11.B.2 11.B.3 11.B.4 11.B.5
Personnel hygiene Clothing Code of Conduct Hand disinfection Health requirements Training
11.C 11.C.1 11.C.2 11.C.3
Production hygiene Sources of contamination Cleaning Disinfection
11.D 11.D.1 11.D.2
Sanitation programme Organisation of room cleaning Documentation
11.E 11.E.1 11.E.2 11.E.3 11.E.4 11.E.5 11.E.6
Environmental monitoring General Sampling plan Establishment of limits and frequencies Methods Investigation areas Evaluation
11.F
GMP in the production process
11.G 11.G.1 11.G.2 11.G.3 11.G.4
Weigh-in Legal requirements Weigh-in principles Weigh-in procedure Documentation
11.H 11.H.1 11.H.2 11.H.3 11.H.4
Identification Handling of labels Labelling of starting materials Labelling of equipment and containers Labelling of rooms
11.I 11.I.1 11.I.2 11.I.3 11.I.4
In-process control Objectives Organisation and responsibilities Carrying out Documentation and evaluation of data
11.J 11.J.1 11.J.2 11.J.3
Prevention of cross-contamination Causes of cross-contamination Measures to prevent cross-contamination Manufacture of critical products
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Deviations Definition Procedure Responsibilities Measures Failure investigation report Evaluation of measures SOP “deviations” – (example) Check-list for deviation handling
11.L 11.L.1 11.L.2 11.L.3 11.L.4 11.L.5
Reworking Definitions Procedure Rework/Reprocessing of rejected products Rework of returned products Rework of products that have not been rejected
11.M 11.M.1 11.M.2 11.M.3 11.M.4 11.M.5 11.M.6 11.M.7 11.M.8 11.M.9
Warehouse and logistics Regulatory requirements Stock management system Responsibilities Personnel Storage areas Storage conditions Sanitation and pest control Material Flow Process Flow
11.N 11.N.1 11.N.2 11.N.3 11.N.4 11.N.5
Transportation Requirements for logistic service providers Transportation challenges and monitoring devices Cool/Cold Chain Distribution Temperature Profiles Transportation Risks
11.O
References
12
Sterile Production
12.A 12.A.1 12.A.2 12.A.3 12.A.4
Introduction Manufacturing of terminally sterilised products Aseptic processing Sterilisation procedures GMP regulations, standards and guidelines
Contents
11.K 11.K.1 11.K.2 11.K.3 11.K.4 11.K.5 11.K.6 11.K.7 11.K.8
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12.B 12.B.1 12.B.2
Air Lock Concepts Personnel locks in the clean area Material locks
12.C 12.C.1 12.C.2 12.C.3 12.C.4 12.C.5
Manufacture of terminally sterilised products Introduction Manufacturing a batch Washing processes Filling Validation
12.D 12.D.1 12.D.2 12.D.3 12.D.4 12.D.5 12.D.6
Sterilisation processes Introduction Normative background of sterilisation Sterilisation methods Steam sterilisation Dry heat sterilisation Radiation sterilisation
12.E 12.E.1 12.E.2 12.E.3 12.E.4 12.E.5
Aseptic processing Room requirements Monitoring Personnel Sterile filtration Validating aseptic processing (media fill)
12.F 12.F.1 12.F.2 12.F.3 12.F.4
Freeze-drying The concept of freeze-drying Freeze dryer design Process monitoring and control Qualification and process validation in freeze-drying
12.G 12.G.1 12.G.2 12.G.3
Testing for Sterility Introduction Parametric release Sterility Test
12.H 12.H.1 12.H.2 12.H.3 12.H.4 12.H.5 12.H.6 12.H.7 12.H.8
Testing for Endotoxins Introduction Methods for detection of endotoxins Tests According to Pharmacopeia Action Limits Gel-Clot Test Photometric Methods Elimination of Interfering Substances Out of Specification (OOS)
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12.I 12.I.1 12.I.2 12.I.3
Testing for Leakage and for Particles Testing for Leakage Testing for Particles Operating Procedure
12.J 12.J.1 12.J.2 12.J.3 12.J.4 12.J.5 12.J.6 12.J.7 12.J.8 12.J.9
Microbiological monitoring Introduction Sources of contamination Room classification Monitoring program Level Methods and equipment Sampling Measures if levels are exceeded Organism identification
12.K
References
13
Packaging
13.A 13.A.1 13.A.2 13.A.3 13.A.4 13.A.5
Packaging material Responsibilities Contents Materials Protection against counterfeit medicinal products Packaging material testing
13.B 13.B.1 13.B.2 13.B.3 13.B.4 13.B.5 13.B.6 13.B.7 13.B.8 13.B.9 13.B.10 13.B.11 13.B.12 13.B.13
Packaging process Allocation of packaging material Line clearance Labelling Control functions Release for production In-process controls Cleaning primary containers Labelling Variable data Imprints Reconciliation Safety features Completion of a packaging process
13.C 13.C.1 13.C.2 13.C.3
Qualification of a packaging line Master qualification plan Design qualification (DQ) Installation qualification (IQ)
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13.C.4 13.C.5
Operational qualification (OQ) Performance qualification (PQ)
14
Laboratory Controls
14.A 14.A.1 14.A.2 14.A.3
Sampling Requirements Sampling plan (instructions) Notes for the sampling process
14.B 14.B.1 14.B.2 14.B.3
Reagents Labeling Usage and stability Documentation
14.C 14.C.1 14.C.2
Standards and reference substances Definition of different standards and their areas of use Handling, storage and stability
14.D 14.D.1 14.D.2
Qualifying laboratory instruments Qualification protocols and reports System suitability test (SST)
14.E 14.E.1 14.E.2 14.E.3 14.E.4
Calibration in the lab Definitions Calibration instructions and record Examples Decision
14.F 14.F.1 14.F.2 14.F.3 14.F.4
Validation of analytical methods Principles Definitions of the parameters Documentation Revalidation
14.G 14.G.1 14.G.2 14.G.3 14.G.4 14.G.5 14.G.6
Stability testing ICH guidelines for stability tests Storage and storage conditions Analyses Reduction of the study design Stability testing in the marketing phase Defining the retest period for an active pharmaceutical ingredient and the shelf life for a drug product through evaluation of stability data (ICH Q1E) Decision tree for data evaluation for retest period or for APIs or drug products (excluding frozen products) Procedure for statistical analysis Examples of the statistical evaluation of stability data
14.G.7 14.G.8 14.G.9
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Out-of-specification results Significance Definitions FDA OOS Guidance Example for handling of an OOS result Trend tracking
14.I 14.I.1 14.I.2
Raw data documentation Principles Single sheet documentation system
14.J 14.J.1 14.J.2 14.J.3 14.J.4
Batch release Certification by a Qualified Person and release in accordance with EC GMP Guidelines Responsibility for issuing the release Publication of release Release procedures in practice
14.K 14.K.1 14.K.2 14.K.3 14.K.4
Microbiological testing Total microbial count Specified microorganisms Testing frequencies Miscellaneous tests
14.L 14.L.1 14.L.2 14.L.3 14.L.4 14.L.5 14.L.6 14.L.7 14.L.8 14.L.9
Pharmacopoeias Structure of Pharmacopoeias General considerations Development of Monographs European Pharmacopoeia (Ph Eur) British Pharmacopoeia (BP) United States Pharmacopeia (USP) Japanese Pharmacopoeia (JP) International Pharmacopoeia (Ph Int) Harmonization
14.M
References
15
Documentation
15.A 15.A.1 15.A.2 15.A.3 15.A.4 15.A.5 15.A.6
Official Requirements Basic Principles of Documentation GMP-relevant Documents Requirements of the US GMP Regulations Document Management System Creating Documents Controlling and monitoring documents
Contents
14.H 14.H.1 14.H.2 14.H.3 14.H.4 14.H.5
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15.B 15.B.1 15.B.2 15.B.3
GMP-conforming documentation Handwritten entries Archiving Master-SOP – “GMP-conforming documentation”
15.C 15.C.1 15.C.2 15.C.3 15.C.4 15.C.5
Batch documentation Manufacturing instructions/record Packaging instruction and batch packaging record Electronic batch recording Testing procedures and test protocol Batch record review
15.D 15.D.1 15.D.2 15.D.3 15.D.4 15.D.5 15.D.6 15.D.7 15.D.8 15.D.9 15.D.10
Standard operating procedures (SOPs) Compilation Approval and implementation Training Usage Review Changes Withdrawing an operating procedure Administration Archiving Example of an SOP “Compilation and administration of operating procedures”
15.E 15.E.1 15.E.2 15.E.3 15.E.4 15.E.5
Site Master File Introduction History Focus of recent update (PE 008-4) Regulatory requirements Guidelines for structure, contents and extent
15.F 15.F.1 15.F.2 15.F.3 15.F.4 15.F.5
Annual product review / Product quality review Documents required for an annual product review Annual product review report Collaboration with a contract manufacturer Example: annual product review Master-SOP for the annual product review
15.G
References
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Research and Development
16.A
General conditions and legal requirements
16.B 16.B.1 16.B.2 16.B.3 16.B.4 16.B.5 16.B.6 16.B.7
Development phases and GMP requirements Formulation development Analytical development Manufacturing and testing of stability samples Packaging development Process development Cleaning verification and validation Process optimization: Basic principles for process validation Up scaling to pilot plant and production scale Handover to other manufacturing sites
16.B.8 16.B.9 16.C 16.C.1 16.C.2 16.C.3
Interfaces to GLP and GCP GLP – Good Laboratory Practice GCP – Good Clinical Practice Interfaces between the areas regulated by GMP and those regulated by GCP
16.D 16.D.1 16.D.2 16.D.3 16.D.4 16.D.5 16.D.6
Manufacture and control of clinical samples Prerequisites for the approval of clinical investigations Manufacturing of clinical samples and comparator drugs Packaging and labeling Control and release of investigational medicinal products Storage and shipment of investigational drugs Returns, recalls and destruction of clinical samples
16.E
Documentation and recording of changes during development
16.F
Development report
16.G 16.G.1 16.G.2 16.G.3 16.G.4 16.G.5 16.G.6 16.G.7
Quality by design (QbD) Introduction The Regulatory Framework The New Quality Paradigm Applying Quality by Design Implementing Quality by Design Application Examples Outlook
16.H
References
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17
Contractors and Suppliers
17.A 17.A.1 17.A.2 17.A.3 17.A.4 17.A.5 17.A.6 17.A.7 17.A.8
Contract manufacture Reasons for contract manufacture Procedure for assigning manufacturing contracts Duties of the contract giver Duties of the contract acceptor Contract manufacturer agreement Audits of contract manufacturers SOP for assigning manufacturing contracts Framework contract for contract manufacture and quality control
17.B 17.B.1 17.B.2 17.B.3 17.B.4 17.B.5 17.B.6
Contract Analysis Introduction Legal background Selection of an external testing laboratory Liability limitation contract Certificate of Analysis Transfer of the test to the contract laboratory
17.C 17.C.1 17.C.2 17.C.3 17.C.4 17.C.5 17.C.6 17.C.7 17.C.8 17.C.9
Suppliers Introduction Definitions Quality systems Records Contracts and quality agreements Supplier review and controls Supplier audits Re-evaluation of Suppliers GMP MANUAL Cross References to Suppliers
17.D
References
18
Inspections
18.A
Principles
18.B 18.B.1 18.B.2 18.B.3 18.B.4
Inspection procedures System-based Product-based Procedure-based Area-based
18.C 18.C.1 18.C.2
Inspectors Technical qualification requirements Personal requirements
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18.D 18.D.1 18.D.2 18.D.3 18.D.4
Organization of inspections Inspection planning Inspection preparation Carrying out the inspections Evaluation and documentation
18.E 18.E.1 18.E.2 18.E.3 18.E.4 18.E.5
Self-inspection Purpose of self-inspection Carrying out the self-inspection Self-inspection documentation Errors and remedial action Follow-up activities
18.F 18.F.1 18.F.2 18.F.3
Inspection of contract manufacturers Purpose of the inspection of contract manufacturer Carrying out inspections of contract manufacturer Handling of changes and deviations
18.G 18.G.1 18.G.2
Inspection of suppliers Purpose of the supplier inspection Carrying out the supplier inspection
18.H
Questionnaire for preparing GMP-inspections
18.I 18.I.1 18.I.2 18.I.3
Inspection of API manufacturers Preparation of the inspection Type of inspection Inspection questionnaire
18.J
References
19
Quality Unit
19.A
General This chapter will be part of a later update.
19.B 19.B.1 19.B.2 19.B.3 19.B.4 19.B.5
The “Qualified Person” according to Directive 2001/83/EC Introduction Legal background of the European “Qualified Person” regulations Qualification and experience Duties and responsibilities Qualified Person and Pharmaceutical Quality Systems
19.C 19.C.1 19.C.2 19.C.3 19.C.4
Change Management Principles of Change Control Boundary Conditions Regulatory aspects Conducting the Change Control Procedure
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19.C.5 19.C.6
Evaluating the Change Control System Documenting the Change Control
19.D 19.D.1 19.D.2 19.D.3 19.D.4 19.D.5 19.D.6 19.D.7 19.D.8
Corrective and Preventive Actions (CAPA) Introduction Regulatory Background Definitions Organizational Integration Documentation and Tracking Efficacy and Sustainability Efficient Implementation Sample SOP “CAPA System“
19.E
References
20
Continual Improvement
20.A
Preface
20.B 20.B.1 20.B.2 20.B.3 20.B.4 20.B.5 20.B.6 20.B.7
Six Sigma Definition What it is / what it does / how it works Goals/Objectives/Benefits Implementation Tools Variations Examples
20.C 20.C.1 20.C.2 20.C.3 20.C.4 20.C.5 20.C.6 20.C.7
Statistical Process Control (SPC) Definition What it is /what it does / how it works Goals/Objectives/Benefits Implementation Tools Variations Examples
20.D 20.D.1 20.D.2 20.D.3 20.D.4 20.D.5 20.D.6
Process Analytical Technology (PAT) Definition The Role of PAT in Pharmaceutical Manufacturing Regulatory Perspective and Guidances PAT instrumentation Application of PAT in a GMP environment Examples of PAT Applications
20.E
References
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21
Active and Inactive Ingredients
21.A 21.A.1 21.A.2 21.A.3 21.A.4 21.A.5 21.A.6 21.A.7 21.A.8 21.A.9 21.A.10 21.A.11 21.A.12 21.A.13 21.A.14 21.A.15 21.A.16 21.A.17 21.A.18 21.A.19
GMP for Active Pharmaceutical Ingredients (APIs) Introduction Quality management Personnel Buildings and facilities Process equipment Documentation and records Materials management Production and in-process controls Packaging and identification labelling of APIs and intermediates Storage and distribution Laboratory controls Validation Change Control Rejection and re-use of materials Complaints and Recalls Contract manufacturers, including laboratories Agents, brokers, traders, distributors, repackers, and relabellers Specific guidance for APIs manufactured by cell culture/fermentation APIs for use in clinical trials
21.B 21.B.1 21.B.2 21.B.3 21.B.4
GMP for APIs – considerations on special topics Materials management Production and maintenance Re-use and recovery of materials Interaction with brokers
21.C 21.C.1 21.C.2 21.C.3 21.C.4 21.C.5 21.C.6 21.C.7
Excipients Introduction Regulatory aspects and guidance documents Safety, toxicological, and precedence of use issues Compendial monographs Excipient Master Files and other filings Applicability of ICH guidance to excipients Other aspects critical to the marketing of excipients
21.D
References
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22
Biologics
23
Medical Devices
23.A 23.A.1 23.A.2 23.A.3 23.A.4
Introduction Definition Types of medical devices Regulatory background Process approach to a Quality Management System
23.B 23.B.1 23.B.2 23.B.3 23.B.4 23.B.5 23.B.6
Quality Management System (QMS) Management responsibility Quality manual Quality policy Quality planning Management review Audits
23.C 23.C.1 23.C.2 23.C.3 23.C.4
Personnel General Training Health, hygiene, practices, and clothing Consultants and contractors
23.D 23.D.1 23.D.2 23.D.3 23.D.4 23.D.5 23.D.6 23.D.7 23.D.8 23.D.9 23.D.10
Design control General Design planning Design input Design output Design review Design verification Design validation / Clinical evaluation Design transfer Design changes Design history file
23.E
Human factors
23.F
Statistical techniques
23.G
Risk management
23.H 23.H.1 23.H.2
Document and record control Control of documents Control of records
23.I 23.I.1 23.I.2
Production and process controls Manufacturing materials Automated processes
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23.I.3 23.I.4 23.I.5
Sterile products Changes Material acceptance procedures
23.J 23.J.1 23.J.2
Identification and traceability Identification Traceability
23.K 23.K.1 23.K.2 23.K.3
Buildings, facilities and equipment Buildings and facilities Environment Equipment
23.L
Validation
23.M 23.M.1 23.M.2
Purchasing/supplier control Purchase orders Quality agreements
23.N 23.N.1 23.N.2
Packaging and labeling Packaging Manufacturer’s information
23.O 23.O.1 23.O.2 23.O.3 23.O.4 23.O.5
Handling, storage, distribution, installation and servicing Handling Storage Distribution Installation Servicing
23.P 23.P.1 23.P.2 23.P.3 23.P.4
Nonconformance, Corrective Action and Preventive Action Definitions CAPA System Nonconforming product Advisory notice, device correction or product recall
23.Q 23.Q.1 23.Q.2
Customer complaints Complaint evaluation Complaint investigation
23.R
Combination products
23.S
References
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A
Empty Register
B
Empty Register
C
EU Directives and Guidelines
C.1
EU GMP Guide: Introduction
C.2
Commission Directive 2003/94/EC
C.3
Commission Directive 91/412/EEC
C.4
Part I Basic Requirements for Medicinal Products
C.4.1
Chapter 1: Pharmaceutical Quality System
C.4.2
Chapter 2: Personnel
C.4.3
Chapter 3: Premises and Equipment
C.4.4
Chapter 4: Documentation
C.4.5
Chapter 5: Production
C.4.6
Chapter 6: Quality Control
C.4.7
Chapter 7: Outsourced Activities
C.4.8
Chapter 8: Complaints and Product Recall
C.4.9
Chapter 9: Self Inspection
C.5
Part II Basic Requirements for Active Substances used as Starting Materials
C.6.1
Annex 1 Manufacture of Sterile Medicinal Products
C.6.2
Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use
C.6.3
Annex 3 Manufacture of Radiopharmaceuticals
C.6.4
Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
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C.6.5
Annex 5 Manufacture of Immunological Veterinary Medicinal Products
C.6.6
Annex 6 Manufacture of Medicinal Gases
C.6.7
Annex 7 Manufacture of Herbal Medicinal Products
C.6.8
Annex 8 Sampling of Starting and Packaging Materials
C.6.9
Annex 9 Manufacture of Liquids, Creams and Ointments
C.6.10
Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
C.6.11
Annex 11 Computerised Systems
C.6.12
Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products
C.6.13
Annex 13 Investigational Medicinal Products
C.6.14
Annex 14 Manufacture of Medicinal Products Derived from Human Blood or Plasma
C.6.15
Annex 15 Qualification and Validation
C.6.16
Annex 16 Certification by a Qualified Person and Batch Release
C.6.17
Annex 17 Parametric Release
C.6.18
Annex 18 Good Manufacturing Practice for Active Pharmaceutical Ingredients
C.6.19
Annex 19 Reference and Retention Samples
C.7
Glossary
C.8
Part III – GMP related documents
C.8.1
Explanatory Notes on the preparation of a Site Master File
C.8.2
Quality Risk Management (ICH Q9)
C.8.3
Pharmaceutical Quality System (ICH Q10)
C.8.4
Internationally harmonised requirements for batch certification GMP Manual (Up14) © Maas & Peither AG – GMP Publishing
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C.8.5
New Rules on Importing Active Pharmaceutical Ingredients into the European Union
C.8.5.1
Importation of Active Substances for Medicinal Products for Human Use Questions and Answers Version 1.0
C.9
Note For Guidance on Quality of Water for Pharmaceutical Use
C.10
Compilation of Community Procedures on Inspections and Exchange of Information
C.10.1
Conduct of Inspections of Pharmaceutical Manufacturers or Importers
C.10.2
Outline of a Procedure for Co-Ordinating the Verification of the GMP Status of Manufacturers in Third Countries
C.10.3
Guideline on Training and Qualifications of GMP Inspectors
C.10.4
Guidance on the Occasions when it is Appropriate for Competent Authorities to Conduct Inspections at the Premises of Manufacturers of Active Substances Used as Starting Materials
C.10.5
The Issue and Update of GMP Certificates
C.10.6
A Model for Risk Based Planning for Inspections of Pharmaceutical Manufacturers
C.10.7
Procedure for dealing with serious GMP non-compliance or voiding/suspension of CEPS thus requiring co-ordinated administrative action
C.11
EU Directives on Medical Devices
C.11.1
Council Directive of 20 June 1990 on the approximation of the laws of the member states relating to active implantable medical devices (90/385/EEC)
C.11.2
Council Directive of 14 June 1993 concerning medical devices (93/42/EEC)
C.11.3
Directive of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (98/79/EC)
C.12
Directive 2001/83/EC of the European Parliament and of the Council
C.13
Guideline on Real Time Release Testing
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D
USA: CFR and FDA Guidelines
D.1
Code of Federal Regulations
D.1.1
21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
D.1.2
21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals
D.1.3
21 CFR Part 11 Electronic Records; Electronic Signatures
D.1.4
21 CFR Part 820 Quality System Regulation
D.2
Guidance for Industry Process Validation: General Principles and Practices
D.3
Guide to Inspections of High Purity Water Systems
D.4
Guide to Inspections of Validation of Cleaning Processes
D.5
Guide to Inspections of oral solid dosage forms pre/post approval issues for development and validation
D.6
Guide to Inspections of Validation Documentation
D.7
Guide to Inspections Computerized Systems in Drug Establishments (2/83)
D.8
Guide to Inspections of Pharmaceutical Quality Control Laboratories
D.9
Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
D.10
Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice
D.11
Guidance for Industry PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
D.12
Guidance for Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application
D.13
Guidance for Industry Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting
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D.14
Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations
D.15
Guidance for Industry cGMP for Phase 1 Investigational Drugs
D.16
Federal Food, Drug, and Cosmetic Act (FD&C Act)
D.17
Pre-Approval Inspections
E
ICH-Guidelines
E.1.A
ICH Q1A(R2): Stability Testing of New Drug Substances and Products
E.1.B
ICH Q1B: Stability Testing: Photostability Testing of New Drug Substances and Products
E.1.C
ICH Q1C: Stability Testing for New Dosage Forms
E.1.D
ICH Q1D: Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
E.1.E
ICH Q1E: Evaluation of Stability Data
E.2
ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology
E.3.A
ICH Q3A(R2): Impurities in New Drug Substances
E.3.B
ICH Q3B(R2): Impurities in New Drug Products
E.3.C
ICH Q3C(R5): Impurities: Guideline for Residual Solvents
E.4
ICH Q4: Pharmacopoeias
E.4.A
ICH Q4A: Pharmacopoeial Harmonisation
E.4.B
ICH Q4B: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
E.4.B.1
ICH Q4B Annex 1: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Residue on Ignition/Sulphated Ash – General Chapter
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E.4.B.2
ICH Q4B Annex 2: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations – General Chapter
E.4.B.3
ICH Q4B Annex 3: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles – General Chapter
E.4.B.4.1
ICH Q4B Annex 4A: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Microbiological Examination of Non-Sterile Products: Microbial Enumerations Tests – General Chapter
E.4.B.4.2
ICH Q4B Annex 4B : Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms – General Chapter
E.4.B.4.3
ICH Q4B Annex 4C: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products: Acceptance Criteria For Pharmaceutical Preparations and Substances for Pharmaceutical Use –General Chapter
E.4.B.5
ICH Q4B Annex 5: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test – General Chapter
E.4.B.6
ICH Q4B Annex 6: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units –General Chapter
E.4.B.7
ICH Q4B Annex 7: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test – General Chapter
E.4.B.8
ICH Q4B Annex 8: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test – General Chapter
E.4.B.9
ICH Q4B Annex 9: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability – General Chapter GMP Manual (Up14) © Maas & Peither AG – GMP Publishing
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E.4.B.10
ICH Q4B Annex 10: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis – General Chapter
E.5.A
ICH Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
E.5.B
ICH Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of R-DNA Derived Protein Products
E.5.C
ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
E.5.D
ICH Q5D: Derivation and Characterisation of Cell Substrates used for Production of Biotechnological/Biological Products
E.5.E
ICH Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process
E.6.A
ICH Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
E.6.B
ICH Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
E.7
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients combined with GMPs for APIs: „How to do“ Document by Cefic/APIC Interpretation of the ICH Q7 Guide
E.7.1
Chapter 1: Introduction
E.7.2
Chapter 2: Quality Management
E.7.3
Chapter 3: Personnel
E.7.4
Chapter 4: Buildings and Facilities
E.7.5
Chapter 5 Process Equipment
E.7.6
Chapter 6: Documentation and Records
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Chapter 7: Materials Management
E.7.8
Chapter 8: Production and In-Process Controls
E.7.9
Chapter 9: Packaging and Identification Labelling of APIs and Intermediates
E.7.10
Chapter 10: Storage and Distribution
E.7.11
Chapter 11: Laboratory Controls
E.7.12
Chapter 12: Validation
E.7.13
Chapter 13: Change Control
E.7.14
Chapter 14: Rejection and Re-use of Materials
E.7.15
Chapter 15: Complaints and Recalls
E.7.16
Chapter 16: Contract Manufacturers (including Laboratories)
E.7.17
Chapter 17: Agents, Brokers, Traders, Distributors, Repackers, and Relabellers
E.7.18
Chapter 18: Specific Guidance for APIs Manufactured by Cell Culture/ Fermentation
E.7.19
Chapter 19: APIs for Use in Clinical Trials
E.7.20
Chapter 20: Glossary
E.8
ICH Q8 (R2): Pharmaceutical Development
E.9
ICH Q9: Quality Risk Management
E.10
ICH Q10: Pharmaceutical Quality System
E.10.1
Quality Implementation Working Group on Q8, Q9 and Q10 Questions & Answers
Contents
E.7.7
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F
PIC/S Guidelines
F.1
PIC/S PI 006-3: Recommendations on Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation
F.2
PIC/S PI 007-6: Recommendation on the Validation of Aseptic Processes
F.3
PIC/S PI 011-3: PIC/S Guidance Good Practices for Computerised Systems in Regulated “GXP” Environments
F.4
PIC/S PI 023-2: Aide-mémoire Inspection of Pharmaceutical Quality Control Laboratories
F.4.1
Annex to PIC/S PI 023-1 Aide-Memoire for Inspections of Pharmaceutical Quality Control Laboratories
F.5
PIC/S PE 008-4: Explanatory notes for pharmaceutical manufacturers on the preparation of a Site Master File
F.6
PIC/S PI 009-3: Aide-mémoire Inspection of Utilities
F.7
PIC/S PI 028-1: Aide-mémoire GMP Inspection Related to Packaging
F.8
PIC/S PI 032-2: Recommendation GMP Annex 1 Revision 2008, Interpretation of Most Important Changes for the Manufacture of Sterile Medicinal Products
F.9
PIC/S PE 009-9: Guide to Good Manufacturing Practice for Medicinal Products – Intro
F.10
PIC/S PE 009-9: Guide to Good Manufacturing Practice for Medicinal Products – Part I
F.11
PIC/S PE 009-9: Guide to Good Manufacturing Practice for Medicinal Products – Part II
F.12
PIC/S PE 009-9: Guide to Good Manufacturing Practice for Medicinal Products – Annexes
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G
GMP of other Regions
G.1
WHO Guidelines
G.1.1
Quality assurance of pharmaceuticals
G.1.1.1
1. WHO good manufacturing practices: main principles for pharmaceutical products
G.1.1.2
2. WHO good manufacturing practices: starting materials
G.1.1.3
3. WHO good manufacturing practices: specific pharmaceutical products
G.1.1.4
4. Inspection
G.1.1.5
5. Hazard and risk analysis in pharmaceutical products
G.1.1.6
6. Sampling operations
G.1.2
WHO TRS 908 (2003), Annex 9: Guide to good storage practices for pharmaceuticals
G.1.3
WHO TRS 957 (2010), Annex 5: Good distribution practices for pharmaceutical products
G.1.4
WHO TRS 961 (2011), Annex 9: Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products )
G.2
Canadian Regulations
G.2.1
Good Manufacturing Practices (GMP) Guidelines – 2009 Edition, Version 2 (GUI-0001)
G.2.2
Canada: Good Manufacturing Practices (GMP) Guidelines – Annexes
G.2.2.1
Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines – Selected Category IV Monograph Drugs (GUI-0066)
G.2.2.2
Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines – Schedule D Drugs, (Biological Drugs) (GUI-0027)
G.2.2.3
Annex 3 to the Current Edition of the Good Manufacturing Practices Guidelines – Schedule C Drugs (GUI-0026)
G.2.2.4
Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines – Veterinary Drugs (GUI-0012)
G.2.2.5
Annex 5 to the Current Edition of the Good Manufacturing Practices Guidelines – Positron Emitting Radiopharmaceuticals (PER’s) (GUI-0071)
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G.2.2.6
Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines – Drugs Used in Clinical Trials (GUI-0036)
G.2.2.7
Annex 14 to the Current Edition of the Good Manufacturing Practices Guidelines – Schedule D Drugs, Human Blood and Blood Components (GUI-0032)
G.3
Japanese Regulations
G.3.1
MHW Ministerial Ordinance No. 2,1961: Regulations for Buildings and Facilities of Pharmacies, etc.
G.3.2
MHLW Ministerial Ordinance No. 136,2004 : Standards for Quality Assurance for Drugs, Quasi-drugs, Cosmetics and Medical Devices
G.3.3
MHLW Ministerial Ordinance No. 179, 2004: Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs
G.4
Chinese Regulations
G.4.1
China Good Manufacturing Practice for Drugs (2010 Revision)
G.4.2
China: Good Manufacturing Practice (2010 revision) Annex 1 to Annex 5 Technical Reviewed by ISPE
G.4.2.1
Annex 1: Sterile Medicinal Products
G.4.2.2
Annex 2: Active Substances Used As Starting Materials
G.4.2.3
Annex 3: Biological Medicinal
G.4.2.4
Annex 4: Blood Products
G.4.2.5
Annex 5: Chinese Medicine Preparations
H
Information
H.1
GMP Abbreviations
H.2
GMP Glossary
H.3
Adresses
H.4
References
GMP Manual (Up14) © Maas & Peither AG – GMP Publishing
www.pda.org/bookstore
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