1. Module 6 | Slide 1 of 15 2012 Contract Production and Analysis Section 7 Basic Principles of GMP

2. Module 6 | Slide 2 of 15 2012 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 15 2012 7.1 – 7.4 Contract Production and Analysis Principle Contract production and analysis - defined, agreed, and controlled. Should be in writing Avoid misunderstandings Ensure work is done as in marketing authorization Define duties and responsibilities of parties Address batch release (authorized person) and issue of certificate of analysis

4. Module 6 | Slide 4 of 15 2012 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 15 2012 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 Products are released by the authorized person

6. Module 6 | Slide 6 of 15 2012 7.8 Contract Production and Analysis Responsibilities of the Contract Acceptor (1) Must have a manufacturing authorization Must have: äthe necessary facilities, premises and equipment to undertake the work ästaff who have the necessary qualifications, knowledge, training and experience to be able to do the work

7. Module 6 | Slide 7 of 15 2012 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 15 2012 7.11 – 7.14 Contract Production and Analysis The Contract (1) Written agreement defining each party’s responsibilities and technical aspects Prepared by competent persons with knowledge in pharmaceutical technology, analysis and GMP Ensure compliance with marketing authorization –Production and analysis –Batch release –COA issued by the authorized person, compliance with marketing authorization –Flow of data and information for product quality review

9. Module 6 | Slide 9 of 15 2012 7.17 Contract Production and Analysis The Contract (2) How does it address rejected materials /products? –starting materials –intermediate and bulk products –finished products What happens if the contract analysis shows that the tested product must be rejected?

10. Module 6 | Slide 10 of 15 2012 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

11. Module 6 | Slide 11 of 15 2012 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

12. Module 6 | Slide 12 of 15 2012 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?

13. Module 6 | Slide 13 of 15 2012 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

14. Module 6 | Slide 14 of 15 2012 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

15. Module 6 | Slide 15 of 15 2012 Contract Production and Analysis Possible Issues – III Contract acceptor uses an alternative material supplier Contract acceptor working with out-of-date specifications