1. Module 6 | Slide 1 of 14 January 2006 Contract Production and Analysis Section 7 Basic Principles of GMP

2. Module 6 | Slide 2 of 14 January 2006 Contract Production and Analysis Objectives To review general issues To understand the responsibilities of: äContract giver äContract acceptor To understand the contract

3. Module 6 | Slide 3 of 14 January 2006 7.1 – 7.4 Contract Production and Analysis Principle Contract production and analysis must be correctly defined, agreed, and controlled: To avoid misunderstandings that could result in unsatisfactory products, work or analysis A written contract should clearly describe: äEach party's duties and responsibilities including audits äClearly state how the authorized person, when exercising his or her full responsibility, releases each batch or issues certificate of analysis

4. Module 6 | Slide 4 of 14 January 2006 7.5 Contract Production and Analysis Responsibilities of the Contract Giver (1) Must assess competence of contract acceptor to do the work or analysis Must assess contract acceptor for compliance with GMP Approve contracted activities

5. Module 6 | Slide 5 of 14 January 2006 7.6 – 7.7 Contract Production and Analysis Responsibilities of the Contract Giver (2) Provide all the necessary information to the contract acceptor in order to: ähave the operations carried out correctly in accordance with the manufacturing authorization and other legal requirements äbe fully aware of any problems with the product, work, tests that might pose a hazard to premises, equipment, personnel, other materials or other products Ensure that materials and products supplied by the contract acceptor are in compliance with specifications, or Products are released by the authorized person

6. Module 6 | Slide 6 of 14 January 2006 7.8 Contract Production and Analysis Responsibilities of the Contract Acceptor (1) Must have a manufacturing authorization Competence: äHave the necessary facilities, premises and equipment to undertake the work äStaff should have the necessary qualifications, knowledge, training and experience to be able to do the work

7. Module 6 | Slide 7 of 14 January 2006 7.9 - 7.10 Contract Production and Analysis Responsibilities of the Contract Acceptor (2) No subcontracting without prior approval to a third party (The contract giver must be able to undertake audits needed to reassure that the third party is competent and approve subcontracting) All the required information should be given to the third party No conflicting activities or practices that could adversely affect the product(s)

8. Module 6 | Slide 8 of 14 January 2006 7.11 - 7.14, 7.17 Contract Production and Analysis The Contract (1) Written: Defining each party’s responsibilities Technical aspects drawn up by competent persons with knowledge in pharmaceutical technology, analysis and GMP Batch release/COA issued by the authorized person, compliance with marketing authorization Production and analysis arrangements as in marketing authorization – agreed to by both parties Describe handling of rejected materials

9. Module 6 | Slide 9 of 14 January 2006 7.15, 7.17 Contract Production and Analysis The Contract (2) Who is responsible for: Material purchasing, testing and releasing Production and quality control including in-process quality control (IPQC) Sampling and analysis In the case of contract analysis: Who takes the sample? Where is the sample taken? Describe procedure if a tested product must be rejected

10. Module 6 | Slide 10 of 14 January 2006 7.16 Contract Production and Analysis The Contract (3) The contract giver should keep or have access to: Reference standards and retention samples Records of: ämanufacturing äanalysis ädistribution In case of recalls, complaints and suspected defects: äall relevant records ädescribed in SOP

11. Module 6 | Slide 11 of 14 January 2006 Contract Production and Analysis Group Session Identify the items that should be included in a contract Why should these items be included? What should you do if you find a contract that does not include these items?

12. Module 6 | Slide 12 of 14 January 2006 Contract Production and Analysis Possible Issues – I Owners insist on using unsuitable facilities Owners insist on using relatives’ facilities No time to validate new facilities Contract acceptor takes on inappropriate new product

13. Module 6 | Slide 13 of 14 January 2006 Contract Production and Analysis Possible Issues – II Contract acceptor does not have all specified equipment Contract acceptor uses incorrect equipment Contract acceptor does not follow agreed procedures

14. Module 6 | Slide 14 of 14 January 2006 Contract Production and Analysis Possible Issues – III Contract acceptor uses an alternative material supplier Contract acceptor working with out-of-date specifications