Supply Chain Strategy - The Logistics of Supply Chain Management

‫بسم ال الرحمن الرحيم‬

Dr/ Ahmed M. Yousry Ragab QA officer Global napi pharmaceutical plant

2. Project initiation: 2.2 Developing the business case: Qualification is an essential part of a pharmaceutical manufacturer’s quality assurance system; it should demonstrate that facilities are suitable for their intended use and should also guarantee that the medicinal products are of an appropriate quality. Qualification is thus a basic factor for drug product safety. Our company, a pharmaceutical manufacturing plant is intending to buy a new tablet compression machine to increase the capacity of the solid dosage forms manufacturing department as these dosage forms were found to be the most profitable and desirable within the bigger market slice. As GMP (good manufacturing practice) requirements are legislative to our company for our products to be FDA approved and thus be able to be exported to highly pharmaceutical products consuming markets, qualification of equipment must be done as stated in chapter 3.34 of the GMP guide line states, manufacturing equipments should be designed, located and maintained to suit its intended purpose. Annex 15 to the EU GMP guideline specifies how this requirement must be implemented.  Identifying the business opportunity: Three of our major tablet products have been FDA approved following the European EMEA approval. We have a great chance to export a great number of batches yearly to the USA and the European pharmaceutical market achieving good sales and reasonable profit, together with the local market. The capacity of our solid dosage forms manufacturing department will not be able to satisfy the new requirement of production so top management have decided to buy a new tablet compression machine. Before buying the tablet compression machine the quality assurance department manager informed the production manager that such step needs to pass through all the stages of qualification as stated in the GMP manual and in the FDA and EMEA requirements manuals. Qualification procedure consists of 4 steps: Design qualification DQ Installation qualification IQ Operation qualification OQ Performance qualification PQ Production manager informed the QA department manager and the chairman that the new tablet compression machine is needed to start production within 3 months maximally starting from the 1st of April 2009 to satisfy the market needs, fulfill the assigned contracts and not to face penalties  Assessing the available options: The available options for Qualifying the tablet compression machine is to: 1Outsourcing the Qualifying process to an external company. 2Doing the qualification using company’s personnel, body of knowledge, experience, knowhow and time.

Quantifying the benefits: The benefits that may be derived from the right and complete qualification of the new tablet compression machine: Table 2.1 Business benefits Benefit Category

Benefit description New revenue generated

Financial

Reduce losses due to modifications after installation

Benefit Value About 70000000 LEs yearly N/A

Improved operational efficiency Enhance Quality of product FDA approval Greater market share EMEA approval Improved Customer satisfaction Increased customer retention

About 15000000 LEs yearly N/A N/A N/A About 40% N/A N/A N/A

Greater customer loyalty

N/A

Staff

Increased validation and qualification in-process knowledge

N/A

Exporting image

Effect on the image to the importer

N/A

Increased profit margin Operational Market

Customer

By using an outsourced company to do the qualification required we will lose the staff gains as they will not be able to do the upcoming qualifications as they didn’t afford the knowledge and the knowhow.

 Forecasting the costs: The costs will actually differs from the toll and the full manufacturing of the effervescent products. This will be described as follows. Table 2.2 Business costs Expenses type

Full project Costs

people

salaries

Physical

Project office Cultural change, lost work due to the taken hours from the project team

Organizational

We will not have any full timers in this project, all the project team members will be part timers with assigned tasks to perform, the overall hours cost of all the team, manager, review group will be of about 10000 LEs Overall cost of 5000 LEs

CAPEX

N/A

OPEX

OPEX

By using an outsourced company there will be no different types of costs, there will be only one fixed cost stated in the contract and is due payable only one time after the last stage of the qualification and after providing all the needed documents and certificates, by using an outsourced company, sources can be more controllable and within limits (stated in the contract) and no failures responsibilities or costs will be held by our company.

The top management ordered that the full implementation of qualification by the companies own personnel is more feasible than the outsourcing as the deliverables can be more controlled. Assessing feasibility: A feasibility studies may need to be undertaken to identify the likelihood of each solution satisfying the business problem or the opportunity. Table 2.3 Solution feasibility Solution Feasibility method of feasibility component rating By reviewing all models with all the new technologies on New the internet, asking companies to provide us with 9 technology complete description of the features provided in the compression machines. No new people were recruited or depended upon as we new 9 use already recruited staff having the knowledge that we people need. Few new processes will occur due to the little differences New 8 that will occur between this qualification process and the process last qualification done to the old compression machine. New Normal and within budget limits as no new assets needed 8 assets out of the project office needs. Identifying the risks: Summarizing the most apparent risks associated with the adoption of each solution. Table 2.4 Business risks Risk description Inability to recruit skilled resources Failure to choose reasonable machine Failure to provide complete design qualifications

Risk likelihood

Risk impact

Low

High

low

High

high

low

Action required to mitigate the risks Complete the required staff members and training Thorough market analysis/collection of user requirements Analysis of the old compression machine and adding the features you need to be present and the imperfections needed to be absent

Solution ranking: Table 2.4 Solution Ranking Assessment Solution1 (full criteria manufacturing)

Solution 2 (Toll manufacturing)

Costs people Physical Organizational

6 5 9

7 5 6

9

9

7

9

9 9

5 6

6 6 5

8 6 8

Benefits increased revenue Reduced expenditure Improved efficacy Enhanced Quality RISKS Resources technology organizational

Total score 71 69 The table shows that the recommended solution will be the implementation of the qualification by the companies own efforts. Documenting the issues: Table 2.5 Business issues Issue description Required capital expenditure funds have not been budgeted Qualification procedures in the GMP manual are not enough Not enough experience within our midline personnel More time is needed to perform complete-steps qualification

issue priority

Action required to resolve the issue

high

Request for approval

low medium low

Request for more detailed procedures from the FDA and the EMEA Ask the advice of the higher management line personnel More time is asked from the project sponsor

List of assumption: 1. There will be no change in the GMP requirements. 2. There will be no change in the FDA requirements. 3. There will be no change in the EMEA requirements. 4. There will be stability in the purchasing, quality assurance and engineering department. 5. Additional resources will be available from the business as required.

2.3 Under taking the feasibility studies: Through undertaking a detailed assessment of a current business problem or opportunity: Table 2.7 Business requirements Business opportunity Project requirement Design, install, operate,  Complete and fully document design qualification measure the performance of a  Complete and fully document installation new compression machine in qualification conformance with the GMP  Complete and fully document operational manual, the FDA requirements, qualification the EMEA requirements  Complete and fully document performance qualification Identifying the solution risks: Listing the apparent risks associated with the implementation of each solution. Table 2.8 Solution risks Risk description Features and options are many and we cannot clearly define what exactly we do need The FDA requirements define certain qualities and options that we cannot afford Upon completing operational qualification, the work produced isn’t meeting the goals Upon completing the performance qualification it is discovered that the premises in the manufacturing room are not enough or stable Documents provided from the manufacturing site were not enough/complete/right

Risk likelihood

Risk impact

Action required to mitigate the risks

Low

low

Define precisely the main and primary features needed

Medium

high

low

High

high

medium

Define precisely the budget offered to buy the compression machine on basis of the future revenues expected Review the goals u need with the manufacturing and the RandD department, perform factory acceptance test at the manufacturers premises.

high

Review the premises needed by the machine from the start of the purchasing stage and these premises must be completed by the time the machine parts reach the factory.

low

The manufacturing company is asked to send a soft copy of the documents via the mail before the hard copy to review them by the quality department and the engineering department before accepting them or asking for modifications

Prioritizing the solution risks: Risk description Upon completing the performance qualification it is discovered that the premises in the manufacturing room are not enough or stable The FDA requirements define certain qualities and options that we cannot afford Upon completing operational qualification, the work produced isn’t meeting the goals

Risk likelihood

Risk impact

Action required to mitigate the risks

high

high

Review the premises needed by the machine from the start of the purchasing stage and these premises must be completed by the time the machine parts reach the factory.

Medium

high

Define precisely the budget offered to buy the compression machine on basis of the future revenues expected

low

High

Documents provided from the manufacturing site were not enough/complete/right

medium

low

Features and options are many and we cannot clearly define what exactly we do need

Low

low

Review the goals u need with the manufacturing and the RandD department, perform factory acceptance test at the manufacturers premises. The manufacturing company is asked to send a soft copy of the documents via the mail before the hard copy to review them by the quality department and the engineering department before accepting them or asking for modifications Define precisely the main and primary features needed

Solution feasibility: Table 2.10 Solution feasibility Full manufacturin Criteria g score 1 Quality of 9 deliverables Change control Work within budget Achieving requirement s Achieving process understandi ng Retrieving knowledge expertise Total Score

Weigh total

Weight total X Score

Toll manufacturin g score2

Weigh total

Weight total X Score

30

270

8

30

240

9

15

135

7

15

105

6

15

90

9

15

135

9

30

270

8

30

240

9

20

180

6

20

120

9

20

180

6

20

120

7

20 1265

140

9

20 1140

180

2.4 Establishing the terms of references: After the identification of the business case and the feasibility studies for the preferred solution the definition of the scope can be established Identifying the project vision: To complete and document an overall qualification of a new tablet compression machine The project objectives: To deliver a stepwise complete and documented qualification of a new tablet compression machine according to the GMP/FDA/EMEA requirements in a period starting from the 1 st of April 2009 till the end of June 2009.

Scope: The project is to start at April 2009 and ends at June 2009. Table 2.11 project deliverables Deliverables Components Purpose of the equipment/facility Legal requirements: laws/regulations/standards Design requirements: technical data/construction and workmanship/accessories and spare parts(balance, code readers, components)/materials of product contact part Requirements of the installation: dimensions, environmental conditions (rooms, energy, utilities, HVAC, safety, environment) Performance data: list of products(specification, in particular dimensions, special features)/description of the sequence of operation (flowchart, variability of the process conditions)/ pulse frequencies, quantity produced/setting-up Design times Qualification Facilities for control, regulation and measurement Requirements for maintenance, cleaning, and care Evidence for functionality of equipment Requirements for the accompanying documentation: technical document, CE certificates of conformity, calibration and gauging certificates, operating instructions, certificates of materials, spare parts list, quality certificates for software, documents for training and instruction of staff Customer service Necessary supplementations and modifications following award of contract Installation schedule at premises of contract giver Documents that verify the installation of equipments, pipes, supply facilities and instruments following check against current engineering drawings and specifications Documents that verify compilation and Installation comparison of operating procedures as well Qualification as maintenance requirements of the supplier Documents that record the requirements for calibration Documents of verification of construction materials Operation QUALIFICATION PROTOCOL:

Description

To conform and document the conformance of the design with the gmp/FDA/EMEA requirements

To conform and document the correct implementation of the aforementioned requirements when assembling and setting up of the facility

To conform and document



Function of the equipment/facility with cross reference to necessary operating instructions or company internal operating procedures



Cross reference to risk analysis



Requirements for calibration



Parameters and associated acceptance criteria to be checked



Directions for carrying out and evaluating the test including the necessary procedures

Qualification

QUALIFICATION REPORT:

Performance Qualification



Calibration status



Results of the qualification tests carried out



Comprehensive interpretation and evaluation of all tests



Evaluation of deviations



Release of equipment following successful completion of qualification

Results of the first pilot batch of the product A against the batch record Results of the first pilot batch of the product B against the batch record Results of the first pilot batch of the product C against the batch record

That the facility is functioning on the basis of established parameters and within defined limits

To demonstrate and document that facilities and equipments as connected together can perform effectively and reproducibly based on the approved process method and product specification

Description of the project organization: Listing the customers who are intended to use the deliverables produced by the project. Table 2.12 project organization Customer

Customer representative

Production department (internal)

Production staff members who will use the tablet compression machine

FDA registration office (external)

FDA registration officer who will audit the Qualification documents

EMEA registration office (external)

EMEA registration officer who will audit the qualification document

Quality Assurance department (internal)

Quality assurance personnel who will document control these documents

Project stakeholders: Listing the persons or entity outside the project that have a key interest or stake in the project. Table 2.13 Project Stakeholders Stakeholders interest Stakeholders CEO

Alignment with company vision

Financial controller

Alignment with company budget

EMEA

Alignment with EMEA requirements

Government body

Compliance with the ministry of health legalization and standards and requirements

FDA

Alignment with FDA requirements

Roles: Identifying the roles required to undertake the project Table 2.14 project roles Resource Role Organization name Giving technical Engineering information about Engineering supervisor engineering issues Giving technical information about Production pharmaceutical Production supervisor manufacturing issues Assessing information given and ask for Quality Quality information needed assurance assurance and state the supervisor requirements needed to be fulfilled Collect needs and requirements, perform market Purchasing purchase search, do feasibility section head studies, contact manufacturers Project Charter organization:

Assignment status

Assignment date

assigned

1-APR-2009

Assigned

1-APR-2009

Assigned

1-APR-2009

Assigned

1-APR-2009

Project plan Milestones: Table 2.16 Project milestones Milestone title Date Ordering the End of April 2009 compression machine Installation of the End of May 2009 compression machine Operating the Mid of June 2009 compression machine Production of the End of June 2009 first three pilot batches Project dependencies: Table 2.17 dependencies Project activity Impact on Ordering the Receiving the compression equipments machine Installation of the Completing the equipments IQ Producing the 1st Completing the pilot batch OQ

Resources Plan: Table 2.18 Project resources Role Start date Installation engineer 1-APR-2009 Production pharmacist 1-APR-2009 Purchasing section 1-APR-2009 head QA supervisor 1-APR-2009

Description The creation of the purchase order/ordering the premise from the manufacturer The assembly of the equipment in the production room Testing the variables of the machine and its ability to achieve required results Analyzing the produced product against limits

Is impacted by

Criticality

Date

Completing design qualifications

High

May 2009

Receiving the equipments

High

June 2009

Completing the IQ

High

June 2009

End date Jun-2009 Jun-2009 May-2009

%effort Part time Part time Part time

Jun-2009

Part time

Financial Plan: Table 2.19 Project finance Expenses type

Full project Costs

people

salaries

Physical

Project office Cultural change, lost work due to the taken hours from the project team

Organizational

We will not have any full timers in this project, all the project team members will be part timers with assigned tasks to perform, the overall hours cost of all the team, manager, review group will be of about 10000 LEs Overall cost of 5000 LEs

CAPEX

About 3000 LEs

OPEX

OPEX

Quality plan: Table 2.20 Project processes Process Time management

Description A check list of the project steps is monthly revised

Cost management

A financial consultant review the monthly project expenses

Quality management

Quality assurance revise the steps of project by the view of Quality

Change management

The Changes that Would occur in other departments as the production department and the warehousing

Risk management Issue management Procurement management Acceptance management

A risk plan is made for the project steps the project team monthly issue the project steps The project team monthly issue the requirements of the procession in that project The team define certain acceptance limits for each step in the project

Communications management

A Certain method for the communication of the team members and other departments is developed

List of all project considerations: Project Risks: Table 2.21 Project risks Risk description Upon completing the performance qualification it is discovered that the premises in the manufacturing room are not enough or stable The FDA requirements define certain qualities and options that we cannot afford Upon completing operational qualification, the work produced isn’t meeting the goals

Risk likelihood

high

Medium

Risk impact

Action required to mitigate the risks

high

Review the premises needed by the machine from the start of the purchasing stage and these premises must be completed by the time the machine parts reach the factory.

high

Define precisely the budget offered to buy the compression machine on basis of the future revenues expected

low

High

Documents provided from the manufacturing site were not enough/complete/right

medium

low

Features and options are many and we cannot clearly define what exactly we do need

Low

low

Review the goals u need with the manufacturing and the RandD department, perform factory acceptance test at the manufacturers premises. The manufacturing company is asked to send a soft copy of the documents via the mail before the hard copy to review them by the quality department and the engineering department before accepting them or asking for modifications Define precisely the main and primary features needed

Project issue: Table 2.22 Project issues Issue description Required capital expenditure funds have not been budgeted Qualification procedures in the GMP manual are not enough Not enough experience within our midline personnel More time is needed to perform complete-steps qualification

issue priority

Action required to resolve the issue

high

Request for approval

low medium low

Request for more detailed procedures from the FDA and the EMEA Ask the advice of the higher management line personnel More time is asked from the project sponsor

2.5Appointing the project team: A team is appointed for this project that is formed of: 1. Project team leader (QA department manager). 2. Production supervisor pharmacist. 3. Engineering department supervisor. 4. Quality assurance supervisor. 5. Purchasing department section head. Setting up the project office: The project team have to meet once weekly for the discussion of the last update in the project status.  Office equipment: 1- Desktop computer. 2- Phone. 3Printer and photocopier. 4Internal phone line. 5Internet access point. 6Intranet access point.  Communication Equipment: Video conference tools must be present for the dealing with the machines and the equipments and material suppliers, also is required for the dealing with the mother companies for more and easy information transfer. 3. Planning phase: 3.2Creation of the project plan: The project milestones: Table 3.2 Project milestones Milestone Completion of user requirements specifications (URS) Choosing the best offer from the best supplier

Description Milestone date Compiling up of all the 20 April 2009 pharmaceutical and technical requirements for the equipment After performing a thorough 30 April 2009 market analysis, market surveys. Offers are received, reviewed. Then feasibility study is done to choose from different suppliers, the

Completion of the Factory Acceptance Tests (FAT) Delivery of the equipments to the manufacturing plant

Completion of Site Acceptance Tests (SAT) Completion of the installation Qualification Completion of operation qualification

Completion of performance qualification

supplier chosen is asked to send the machine specifications, then a design review is done to compare between specifications and requirements. If the result of the design review is acceptable, a contract is signed Tests to confirm acceptance at the suppliers premises The release of the machines from the receiving marine and the approval of entrance to the manufacturing plant through the governmental side Tests done to confirm acceptance after delivery to the pharmaceutical manufacturing plant Tests done to confirm the right and complete assembling and setting up of the facility Tests done to ensure that the facility is functioning on the basis of established parameters and within defined limits Tests done to ensure that the facilities, systems and equipments as connected together can perform effectively and reproducibly based on the approved process method and product specification.

15 May 2009 5 Jun 2009

10 Jun 2009

12 Jun 2009

24 Jun 2009

29 Jun 2009

The project activity: Table 3.3 Project Activities Phase Activity Project planning Complete URS

commissioning

Complete DQ

Description Complete a document which defines all the users’ pharmaceutical and technical requirements for the equipment. The job is put out to tender, quotations are compared, decisions are made, the order is place and final acceptance is carried out Completion and documentation of all the design qualification requirements

Perform FAT

Tests to confirm acceptance at the suppliers premises

Perform SAT

Tests done to confirm acceptance after delivery to the pharmaceutical manufacturing plant To conform and document the correct implementation of the aforementioned requirements when assembling and setting up of the facility To conform and document That the facility is functioning on the basis of established parameters and within defined limits To demonstrate and document that facilities and equipments as connected together can perform

Perform IQ

Perform OQ

Perform PQ

Sequence After the procurement decision have been taken by the top management

After completion of the URS and its approval by all the users

After commissioning step has been completed and original documents have been delivered by the manufacturer After commissioning step has been completed and after the approval of the manufacturer After the delivery of the whole facility and its installation During the installation of the facility

After performing and completion of the IQ

After performing and completion of the OQ

effectively and reproducibly based on the approved process method and product specification

Project tasks: Table 3.4 Project tasks Phase Activity Project planning Complete DQ

Task  Involving different areas of the company to produce informal requirement profile of the new facility  Describe requirements , process, product capacity  Describe the agreement with the contract acceptor regarding implementation and handling  Describe the requirements of the contract giver for the scope of supply and service  Transfer requirement profile into user requirements

Sequence 1st

2nd

3rd

4th

5th

 Qualify and test user requirements

6th

 Thorough market analysis is done to know what offers are available

7th

 Performing supplier qualification

8th

 User requirements are dispatched to suitable supplier  Supplier compile technical specification on the basis of the used requirements and forward this to the prospective customer Then these Technical

9th

10th

specifications are compared with the user requirements and the GMP requirements. If the technical specification corresponds with the user requirements;  factory acceptance test 11th is done to make sure that the user requirements are compiled with at the manufacturers premises

Perform SAT

Perform IQ

 review the documentation of the design phase

12th

 Purchase contract is concluded

13th



Completion and documentation of all the Tests done to confirm acceptance after delivery to the pharmaceutical manufacturing plant  Implementation of the design qualification requirements when assembling the facility is documented in IQ 

Visual examination is done to the delivered components to ensure fault free workmanship, correct assembly, correct

1st

1st

2nd

setup, correct implementation of all utility connections and connection with upstream and downstream machines All deviations during installation is documented to be assessed for the need of a defect list with responsibilities and deadlines, the results are then listed in a final report and comprehensively checked once again

3rd

 Method of testing and acceptance criteria must be defined prior to start

1st



Perform OQ

Perform PQ



Practical tests are done to check each function in detail



Implementation of disinfectants and maintenance work should be checked at this stage

 Results of the first pilot batch of the product A against the batch record  Results of the first pilot batch of the product B against the batch record  Results of the first pilot batch of the product C against the batch record

2nd

3rd

1st

2nd

3rd

Project efforts: Table 3.5 Project effort Task  Involving different areas of the company to produce informal requirement profile of the new facility  Describe requirements , process, product capacity  Describe the agreement with the contract acceptor regarding implementation and handling  Describe the requirements of the contract giver for the scope of supply and service  Transfer requirement profile into user requirements 

Qualify and test user requirements

 Thorough market analysis is done to know what offers are available 



3 hours



2 hours



3 hours



3 hours



5 days



4 hours

Performing supplier qualification

 User requirements are dispatched to suitable supplier  Supplier compile technical specification on the basis of the used requirements and forward this to the prospective customer Then these Technical specifications are compared with the user requirements and the GMP requirements. If the technical specification corresponds with the user requirements;  factory acceptance test is done to make sure that the user requirements are compiled with at the manufacturers premises  review the documentation of the design phase 

Efforts  5 hours



1 day



3 days



2 days



1 day



7 days



2 days

Purchase contract is concluded

 Completion and documentation of all the Tests done to confirm acceptance after delivery to the pharmaceutical manufacturing plant  Implementation of the design qualification requirements when assembling the facility is documented in IQ  Visual examination is done to the delivered components to ensure fault free workmanship, correct assembly, correct setup, correct implementation of all utility connections and connection with upstream and downstream machines  All deviations during installation is documented to be assessed for the need of a defect list with responsibilities and deadlines, the results are then listed in a final report and comprehensively checked once again

 Method of testing and acceptance criteria must be defined prior to start

3 days



3 days



4 hours



3 days



1 day

 Practical tests are done to check each function in detail



3 days

 Implementation of disinfectants and maintenance work should be checked at this stage



1 day

 Results of the first pilot batch of the product A against the batch record

 1 day

 Results of the first pilot batch of the product B against the batch record



1 day

 Results of the first pilot batch of the product C against the batch record



1 day

Project resources. Table 3.6 Project resources Task  Involving different areas of the company to produce informal

Resources position QA manager and QA supervisor

requirement profile of the new facility  Describe requirements , process, product capacity  Describe the agreement with the contract acceptor regarding implementation and handling

 Describe the requirements of the contract giver for the scope of supply and service

QA supervisor Production supervisor, engineering supervisor, purchasing section head

Purchasing section head QA supervisor

 Transfer requirement profile into user requirements  

Qualify and test user requirements

 Thorough market analysis is done to know what offers are available



Performing supplier qualification

QA supervisor, engineering supervisor, production supervisor

Purchasing section head

Purchasing section head Purchasing section head

 User requirements are dispatched to suitable supplier  Supplier compile technical specification on the basis of the used requirements and forward this to the prospective customer Then these Technical specifications are compared with the user requirements and the GMP requirements. If the technical specification corresponds with the user requirements;  factory acceptance test is done to make sure that the user requirements are compiled with at the manufacturers premises  review the documentation of the design phase

Supplier to purchasing to QA supervisor, production supervisor, engineering supervisor

Production supervisor, engineering supervisor, QA supervisor

QA supervisor, QA manager

Purchasing section head 

Purchase contract is concluded

 Completion and documentation of all the Tests done to confirm acceptance after delivery to the pharmaceutical manufacturing plant  Implementation of the design qualification requirements when assembling the facility is documented in IQ

QA supervisor Production supervisor Engineering supervisor Engineering supervisor, production supervisor, QA supervisor

 Visual examination is done to the delivered components to ensure fault free workmanship, correct assembly, correct setup, correct implementation of all utility connections and connection with upstream and downstream machines

QA supervisor, engineering supervisor

 All deviations during installation is documented to be assessed for the need of a defect list with responsibilities and deadlines, the results are then listed in a final report and comprehensively checked once again

QA supervisor

 Method of testing and acceptance criteria must be defined prior to start

Production supervisor, QA supervisor

 Practical tests are done to check each function in detail

Production supervisor, QA supervisor, engineering supervisor

 Implementation of disinfectants and maintenance work should be checked at this stage

Production supervisor, QA supervisor

 Results of the first pilot batch of the product A against the batch record

Production supervisor, QA supervisor

 Results of the first pilot batch of the product B against the batch record

Production supervisor, QA supervisor

 Results of the first pilot batch of the product C against the batch record

Production supervisor, QA supervisor

Project dependencies: Table 3.7 Project dependencies Activity Depend on Completion of user Requisition of user requirements specifications requirements (URS) Choosing the best offer from Completion of user the best supplier requirements Completion of the Factory Performing feasibility study, Acceptance Tests (FAT) supplier qualification, comparing between technical specifications and user requirements Delivery of the equipments to Completion of FAT and the manufacturing plant signing contract Completion of Site Delivery of the equipments Acceptance Tests (SAT) Completion of the installation Delivery of the equipments Qualification Completion of operation Completion of the installation qualification Qualification Completion of performance Completion of operation qualification qualification Assumptions: The project will not change in the scope. The resources identified will be available upon request Approved funding will be available upon request Creation of the resources Plan: The list of resources: Human resources Engineering department: Engineering supervisor Purchasing department: Purchasing section head Production Department: Production supervisor Quality assurance Department: Quality assurance supervisor Quality assurance manager Equipments printer laptop desktop Internet access point Microsoft windows Microsoft office Materials paper ink electricity

Dependency type End to start End to start End to start

End to start End to start End to start End to start End to start

Labor Listing: Table 3.8 labor listing Role

No

Project manger

1

Engineering supervisor

1

Purchasing section head

1

QA supervisor

1

Production supervisor

1

Summarized Responsibilities Delivering the approved solutions to meet the full requirements of the customers Provide technical support Purchasing, supplier qualification, commissioning, feasibility studies Fulfilling qualification requirements Provide technical support, pharmaceutical production knowledge

Summarized Skills

Start date

End date

Time management, Cost management Quality management People management

1st of April 2009

30th of Jun 2009

Installation experience Technical problem solving Commissioning experience, feasibility study experience

1st of April 2009

30th of Jun 2009

1st of April 2009

15th of May 2009

Experience in qualification, solid dosage form pharmaceutical production Experience in challenging tests, broad knowledge of the compression machines variables

1st of April 2009

30th of Jun 2009

1st of April 2009

30th of Jun 2009

Equipment Listing: Table 3.9 equipment listing Item No Purpose Printer and 1 To print and photocopier photocopy needed documents

laptop

1

desktop

1

Internet access point

1

Intranet access point

1

Microsoft windows suite Microsoft office package

2 2

For the project manager to follow up and manage the project from inside and outside the office For the QA supervisor to manage the data acquired and to produce the required documents. For the purchasing supervisor to perform complete market analysis and to get in touch with different suppliers For emailing work colleagues asking for information to be provided or work to be done For the desktop and the laptop For the desktop and the laptop

Specification high speed black and white laser printer integrated with high speed economical photocopier Light weight, high speed processor

Start date 1st of April 2009

End date 30th of Jun 2009

1st of April 2009

30th of Jun 2009

High speed, with LCD screen

1st of April 2009

30th of Jun 2009

512 kbps, secured

1st of April 2009

30th of Jun 2009

100 Mbps, secured

1st of April 2009

30th of Jun 2009

Vista

1st of April 2009 1st of April 2009

30th of Jun 2009 30th of Jun 2009

Start date 1st of April 2009 1st of April 2009 1st of April 2009

End date 30th of Jun 2009 30th of Jun 2009 30th of Jun 2009

2007

Material listing: Table 3.10 Material Listing Item Component Amount paper Pack of 500 sheets 2 Laser printer filling cartridge Ink cartridge

Cartridge enough for 1000 papers Cartridge enough for 1000 papers

1 1

Resources schedule: Table3.11 Resources schedule Attached in a separate paper

3.4 Creation of the financial plan: Forecast of the costs: Listing the labor within the project and specifying their unit cost: Table 3.12 labor costs Role Unit cost Project manger 300L.E Per day/ 37.5 per hour Engineering supervisor 80L.E Per day/ 10 per hour Purchasing section head 160L.E Per day/ 20 per hour QA supervisor 80L.E per day/ 10 per hour Production supervisor 80L.E per day/ 10 per hour Listing the Equipment required for the project: Table 3.13 Equipment costs Equipment item Printer and photocopier laptop desktop Internet access point Microsoft windows package Microsoft office package

Unit cost 1500 L.E 4500 L.E 2000 L.E 48 L.E per month 350 L.E 300 L.E

Listing any administration costs that are Associate with the costs of the project: Table 3.15 Administrative costs Material Items Unit cost Paper package of 500 sheets each 19 L.E each Laser printer filling cartridge 150 L.E each Ink cartridge 150 L.E each The expenses Schedule is prepared the months from Feb. till sep. 2008:

Table 3.17 Expenses schedule: Attached in a separate paper.

Month Jun.

Jul.

Aug.

Sep.

Week Expenses type Labor Project manger Engineering supervisor Assistant technician (mechanical) Assistant technician For utilities Researcher for the new product formulae Production supervisor Registration specialist Equipment Compression machine with the associated tools power consumption Preparation machine with the associated tools power consumption Single Punch machine for the researches with the associated tools power consumption Separate PC for the effervescent production room Special HAVAC System for the Production rooms power consumption Administration Fees

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

Total m

1200 640

1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 1200 640 640 640 640 640 640 640 640 640 640 640 640 640 640 640

3 1

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

160

3

160

160

160

160

160

160

160

160

160

160

160

160

1

264

264

264

264

264

264

264

264

264

264

264

264

264

264

264

264

8

640

640

640

640

640

640

640

640

640

640

640

640

640

640

640

640

1 6

120

120

120

120

120

120

120

120

1

120

120

120

120

120

120

120

120

1

120

120

120

120

120

120

120

120

1

80

80

80

80

120

120

120

120

Registration of the single product regulatory fees The taxes and fees for the entrance of the machines in the production plant Shipment fees Hosting of the foreign consultants fees Total

20000

6

1

5 2000

2000 2000 2000

24984 4984 4904 4904 3264 3264 3184 3184 3424 3424 3424 3424 3424 3424 3424 3424

8

3.5Creation of the quality plan: First of all the identification of the deliverables and the quality criteria for the project and the identification of the quality targets; Table 3.19 Quality targets Quality targets Project requirements Project deliverables Quality criteria Quality standards Complete and right 1. Design Review the FDA requirements compression machine qualification deliverables to GMP requirements qualification 2. Installation check that all the EMEA qualification requirement are requirements 3. Operation present and all qualification protocols are 4. Performance completed: qualification  DQ tested and reviewed  IQ tested and reviewed  OQ tested and reviewed  PQ tested and reviewed Quality assurance plan is under taken to provide the customer with assurance for the quality targets specified above will be met. Table 3.20 Quality Assurance Plan Q.A Plan Technique Description Frequency Under taking the quality We will review the quality Monthly review deliverables by: Monthly review the project deliverables. Appointing the project manager who is responsible for the quality of the deliverables produced by the project. Under taking the change Will undertake and review the Throughout the project control changes that may occurs in the manufacturing plant for the installation and the performance of the machines in there specified rooms Under taking the review for Review of the validation of Throughout the project. the quality validation. installation and performance and operation also the validation of cleaning in the methods of cleaning of the of the machines after each product.

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 Quality control plan. Q.C is defined as the curative steps taken to eliminate the any variance in the quality of the deliverables produced from the quality target sets. Table 3.21 Quality control Plan Q.C Plan Technique Description Frequency Phase review At the end of each project At the end of each project phase the formal phase review mile stone will be undertaken Documentation review Review all the project Throughout the project. documentation at the end of each phase 3.6 Creation of the risk plan: The plan is created through the identification of the risks and the categories of the risks. Referring to the table number: 3.22 Risk List 3.23 Risk likelihood 3.24 Risk Impact The table 3.25 of the risk priority could be obtained

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 Creation of the risk schedule: Table no: 3.26 Risk Priorities: Risk ID

Likelihood

Impact

Priority

Rating

1.1

20

80

50

medium

1.2

20

100

60

medium

1.3

40

60

50

medium

2.1

60

80

70

high

2.2

40

60

50

medium

2.3

80

80

80

high

3.1

60

40

50

medium

3.2

40

40

40

low

3.3

40

40

40

low

4.1

60

60

60

medium

4.2

60

60

60

medium

4.3

40

100

70

high

5.1

20

80

50

medium

5.2

20

80

50

medium

5.3

60

80

70

high

6.1

20

80

50

medium

6.2

20

60

40

low

6.3

20

80

50

medium

7.1

60

60

60

medium

7.2

60

60

60

medium

7.3

60

60

60

medium

8.1

20

40

30

low

8.2

40

40

40

low

8.3

80

80

80

high

9.1

20

60

40

low

9.2

40

100

70

high

9.3

20

80

50

medium

10.1

60

80

70

high

10.2

20

100

60

high

11.1

60

80

70

high

11.2

60

80

70

high

11.3

40

60

50

medium

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By sorting the upper tables the High rating of the risk priority are: Risk ID Likelihood Impact Priority 2.1 60 80 70 2.3 80 80 80 4.3 40 100 70 5.3 60 80 70 8.3 80 80 80 9.2 40 100 70 10.1 60 80 70 10.2 20 100 60 11.1 60 80 70 11.2 60 80 70

Page 40

Rating high high high high high high high high high high

A Risk Schedule as follows: In the table 3.27: Risk Preventive Rating ID action

high

high

high

high

high

high

Action resource

Action date

2.1

Clearly identify the business benefits

Project sponsor

20-Mar2009

2.3

Clearly identify the business benefits

Project sponsor

20-Mar09

4.3

Specify certain accountant for the recording of the project spent

Project manger

20-Mar09

5.3

Review after each step the output obtained and comparing with the customer requirement

Project manger

After each step

8.3

9.2

Tracing the delivery of the procurement and there arrivals Review after each step the output obtained and comparing with the customer requirement with the addition of the obvious and clear market survey of the product

Project manger

Project manger

Action resources

Action date

Project manger

20-Mar2009

Project manger

20-Mar09

Project manger

15-Mar09

Quality assurance officer

During each step

20-May -09

weekly inquiry from the supplier by the status of the orders

Project manger

Starting from 1apr-2009

After each step

In process control for the project steps to insure that the project output will reach the customer requirements

Quality assurance officer

During each step

Page 41

Contingent Actions Measure the actual business benefits achieved by the project Measure the actual business benefits achieved by the project Outsourcing of a finance company for the monitoring of the project budget In process control for the project steps to insure that the project output will reach the customer requirements

Ratin g

high

high

Ris k ID

Preventive action

10. 1

Through the weekly meetings

10. 2

Weekly report to the stakeholders

high

11. 1

high

11. 2

Action resourc e

Action date

Contingent Actions

Action resources

The establishment Starting of the intranet Project from the for the ease of Project manger first of communicatio manger march n through the team members The attendance of Starting stakeholders Stakeholders Project from the representative representative manger first of s in the s march weekly meetings

Testing the staff at the beginning of Out sourcing Starting the project for or hiring partProject from the the timers for the manger first of assurance of project time march the only Qualification in the project Ensuring the overcoming presence of the shortage Starting all the of the Project from the equipments equipments manger first of at the through the march beginning of outsourcing or the project hiring

Page 42

Action date

At the beginnin g of April

Starting from the first of march

Project manger

At the beginnin g of April

Project manger

At the beginnin g of April

3.7Creation of acceptance plan: The first step is to identify the acceptance criteria through defining first the milestones and the deliverables then the identification of the standers to meet the customer acceptance. Table no. 3.28 Acceptance Milestones Milestones Deliverables Milestone title Description Name Description Ordering the The approval of the Complete design The design compression machine purchasing manger qualification qualification is a and the CEO on the document that purchasing of the verify the compression machine conformance of the design with the gmp, FDA, EMEA requirements Installation of the Starting of the Complete installation Installation compression machine installation phase of qualification qualification is a the compression document which machine after all the verify a complete, constituents are stepwise, right delivered installation of the compression machine Operating the Start operating the Complete operational Operational compression machine compression machine qualification qualification is a after being installed document that and empowered verify that the facility is operating on the basis of established parameters and within defined limits Production of the first Producing three Complete Performance three pilot batches complete batches of performance qualification is a three different qualification document that products and verify that facilities comparing the results equipments and with the standards systems as connected together can perform effectively and reproducibly

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Table 3.29 Acceptance criteria Deliverable Complete design qualification

Complete installation qualification

Complete operational qualification

Complete performance

Criteria  Purpose of the equipment, facility  Legal requirements  Design requirements  Requirements for the installation  Performance data  Facilities of control, regulation and measurement  Requirements of maintenance, cleaning, care  Evidence of functionality of the equipment  Requirements of the accompanying documentation  Customer service  Necessary supplementation and modifications following award of contract  Installation schedule at premises of contract giver  Installation of equipment, pipes, supply facilities and instruments following check against current engineering drawings and specifications  Compilation and comparison of operating procedures as well as maintenance requirements of the supplier  Requirements of the supplier  Verification of construction materials  Calibration status  Results of the qualification tests carried out  Comprehensive interpretation and evaluation of all tests  Evaluation of deviations  Release of equipment/facility following successful completion of qualification  Results of the first pilot Page 44

Standards FDA requirements EMEA requirements GPA requirements

FDA requirements EMEA requirements GPA requirements

FDA requirements EMEA requirements GPA requirements

FDA requirements

qualification

batch of product a  Results of the first pilot batch of the product b  Results of the first pilot batch of the product c

EMEA requirements GPA requirements

After the determination of the milestones and there standards and the criteria of acceptance the acceptance schedule can be established.

Page 45

Table 3.29 Acceptance Schedule Completion Deliverables milestone Ordering the Complete design compression qualification machine

Date 30 Apr 2009

Acceptance review Review the orders and the specification mentioned in it

Installation of the compression machine

Complete installation qualification

12 Jun 2009

Review installation against instructions

Operating the compression machine

Complete operational qualification

24 Jun 2009

Testing the operation against requirements

Production of the first three pilot batches

Complete performance qualification

29 Jun 2009

Comparing the manufactured product against batch record

Reviewers

Date

Project manager Q.A officer Production supervisor Engineering Supervisor Project manager Q.A officer engineering supervisor Engineering Supervisor, Production supervisor, QA supervisor Engineering Supervisor, Production supervisor, QA supervisor

1 May 2009

12 Jun 2009

24 Jun 2009

29 Jun 2009

Assumptions and Risks; 1-There will be no change in the project requirements during the project. 2-Acceptacne criteria will not change during the project. 3-The reviewers will be available to conduct the review. 4-The resources allocated to undertake the acceptance review may not be appropriately skilled to complete each review that is required.

Page 46

3.8Creation of the communication plan: Identification of the communication requirements: First a list for the stakeholders: 1-Project sponsor (CEO) 2-Project manger 3-Project members a. Production supervisor b. Engineering supervisor c. Quality assurance supervisor d. Purchasing section head Then listing the requirements of the communication for each member in the project: Table 3.31 Communication requirements Stakeholder Information Requirements Project Project Status (budget, Scope) Sponsor Project Project Status (budget, Scope) manager Detailed knowledge of the risks and list of assumptions Information regarding the proposed changes Project Project Status activities that a required from each member members Quality Progress of deliverables against the quality standards. manger

Page 47

Building a communication Schedule: Table3.32 Communication schedule I.D Event Description Purpose 1 Project team Meeting To keep the meetings involving all team informed team for the status members and the issues and risks 2 Quality Meeting To insure that reviews discussing the progress is meetings the progress achieving the in the project quality goals against the Quality standards 3 Customer Held with the To provide the acceptance customer to controlled meetings obtain the acceptance of final the deliverables acceptance and ensure that the customer requirements are met 4 Status report Report the To keep all the status of the stakeholders of project and the project the schedule informed for the status. 5 Supplier Regular To provide with performance meeting with the supplier meetings each performance supplier to and resolve the discuss the supplier issues performance

Page 48

Method Verbal

Frequency Weekly

Date During the months from march 2008 till June 2008

Verbal

Monthly

Beginning of each month from the march till June

Verbal

Following the deliverables completion

After the deliverables completion At the end of June 2008

Status report send be electronic mail Verbal

Weekly

During the months from march till June.

Monthly

During the months from march 2008 till June 2008