Basic Principles of GMP Contract Production Analysis and

Basic Principles of GMP Contract Production, Analysis and other activities Section 7 Module 6 | Slide 1 of 16 2013

Contract Activities Objectives l To review general issues l To understand the responsibilities of: ä Contract giver ä Contract acceptor l To understand the contract (Also referred to as “outsourced activities”) Module 6 | Slide 2 of 16 2013

Contract Activities Principle l Contract production, analysis and any other outsourced activity defined, agreed, and controlled. l Should be in writing – to avoid misunderstandings l Ensure work is done to GMP and as in marketing authorization l Define duties and responsibilities of parties l Address batch release (authorized person) and issue of certificate of analysis 7. 1 – 7. 4 Module 6 | Slide 3 of 16 2013

Contract Activities Responsibilities of the Contract Giver (1) l Must have a PQS in place, allowing for control and review of outsourced activities. Assess legality, suitability, competence l Ensure compliance with GMP and QRM principles applied l Approve contracted activities l Monitor and review its performance, including improvements and effectiveness thereof. 7. 5. – 7. 9. l Ensure understanding of inspections by regulators Module 6 | Slide 4 of 16 2013

Contract Activities Responsibilities of the Contract Giver (2) l Provide all the necessary information to the contract acceptor in order to: ä have the operations carried out correctly in accordance with the manufacturing authorization and other legal requirements ä be fully aware of any hazards with the product, work, tests that might pose a risk to premises, equipment, personnel, other materials or other products l Ensure that materials and products supplied by the contract acceptor are in compliance with specifications l Products are released by the authorized person 7. 6 – 7. 7 Module 6 | Slide 5 of 16 2013

Contract Activities Responsibilities of the Contract Acceptor (1) l Must have a manufacturing authorization l Must have: äAdequate premises, equipment, knowledge, experience äCompetent personnel 7. 10 Module 6 | Slide 6 of 16 2013

Contract Activities Responsibilities of the Contract Acceptor (2) l No subcontracting to a third party without prior approval (The contract giver must be able to undertake audits needed to reassure that the third party is competent and approve subcontracting) l All the required information should be given to the third party l No conflicting activities or practices that could adversely affect the product(s) 7. 11. - 7. 12. Module 6 | Slide 7 of 16 2013

Contract Activities The Contract (1) l Written agreement defining each party’s responsibilities and technical aspects – activities, products, operations, communication process l Prepared by competent persons with knowledge in pharmaceutical technology, analysis and GMP l Ensure compliance with marketing authorization – Production and analysis – Batch release 7. 13. , 7. 15. , 7. 16. – COA issued by the authorized person, compliance with marketing authorization – Flow of data and information for product quality review Module 6 | Slide 8 of 16 2013

Contract Activities The Contract (2) l Batch release, and issuing of COA described l Knowledge management l Technology transfer l Supply chain l Sub contracting l Testing and release of material 7. 14. , 7. 17. l Production, quality control, in process control Module 6 | Slide 9 of 16 2013

Contract Activities The Contract (3) l How does it address rejected materials /products? – starting materials – intermediate and bulk products – finished products l What happens if the contract analysis shows that the tested product must be rejected? 7. 19. Module 6 | Slide 10 of 16 2013

Contract Activities The Contract (4) Who is responsible for: l Material purchasing, testing and releasing l Production and quality control including in-process quality control (IPQC) l Sampling and analysis In the case of contract analysis: l Who takes the sample? 7. 15, 7. 17 l Where is the sample taken? l Describe procedure if a tested product must be rejected Module 6 | Slide 11 of 16 2013

Contract Activities The Contract (4) The contract giver should keep or have access to: l Reference standards and retention samples l Records of: ä manufacturing ä analysis ä distribution l In case of recalls, complaints and suspected defects: ä all relevant records ä described in SOP 7. 18. Module 6 | Slide 12 of 16 2013

Contract Activities Group Session l Identify the items that should be included in a contract l Why should these items be included? l What should you do if you find a contract that does not include these items? Module 6 | Slide 13 of 16 2013

Contract Activities Possible Issues – I l Owners insist on using unsuitable facilities l Owners insist on using relatives’ facilities l No time to validate new facilities l Contract acceptor takes on inappropriate new product Module 6 | Slide 14 of 16 2013

Contract Activities Possible Issues – II l Contract acceptor does not have all specified equipment l Contract acceptor uses incorrect equipment l Contract acceptor does not follow agreed procedures Module 6 | Slide 15 of 16 2013

Contract Activities Possible Issues – III l Contract acceptor uses an alternative material supplier l Contract acceptor working with out-of-date specifications Module 6 | Slide 16 of 16 2013