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Contract Production, Analysis and other activities

Basic Principles of GMP. Contract Production, Analysis and other activities. Section 7. Contract Activities. Objectives To review general issues To understand the responsibilities of: Contract giver Contract acceptor To understand the contract

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Contract Production, Analysis and other activities

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  1. Basic Principles of GMP Contract Production, Analysis and other activities Section 7

  2. Contract Activities Objectives • To review general issues • To understand the responsibilities of: • Contract giver • Contract acceptor • To understand the contract (Also referred to as “outsourced activities”)

  3. Contract Activities Principle • Contract production, analysis and any other outsourced activity - defined, agreed, and controlled. • Should be in writing – to avoid misunderstandings • Ensure work is done to GMP and as in marketing authorization • Define duties and responsibilities of parties • Address batch release (authorized person) and issue of certificate of analysis 7.1 – 7.4

  4. Contract Activities Responsibilities of the Contract Giver (1) • Must have a PQS in place, allowing for control and review of outsourced activities. Assess legality, suitability, competence • Ensure compliance with GMP and QRM principles applied • Approve contracted activities • Monitor and review its performance, including improvements and effectiveness thereof. • Ensure understanding of inspections by regulators 7.5. – 7.9.

  5. Contract Activities Responsibilities of the Contract Giver (2) • Provide all the necessary information to the contract acceptor in order to: • have the operations carried out correctly in accordance with the manufacturing authorization and other legal requirements • 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 • Ensure that materials and products supplied by the contract acceptor are in compliance with specifications • Products are released by the authorized person 7.6 – 7.7

  6. Contract Activities Responsibilities of the Contract Acceptor (1) • Must have a manufacturing authorization • Must have: • Adequate premises, equipment, knowledge, experience • Competent personnel 7.10

  7. Contract Activities Responsibilities of the Contract Acceptor (2) • 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) • All the required information should be given to the third party • No conflicting activities or practices that could adversely affect the product(s) 7.11. - 7.12.

  8. Contract Activities The Contract (1) • Written agreement defining each party’s responsibilities and technical aspects – activities, products, operations, communication process • 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 7.13., 7.15., 7.16.

  9. Contract Activities The Contract (2) • Batch release, and issuing of COA described • Knowledge management • Technology transfer • Supply chain • Sub contracting • Testing and release of material • Production, quality control, in process control 7.14., 7.17.

  10. Contract Activities The Contract (3) • 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? 7.19.

  11. Contract Activities The Contract (4) 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 7.15, 7.17

  12. Contract Activities The Contract (4) The contract giver should keep or have access to: • Reference standards and retention samples • Records of: • manufacturing • analysis • distribution • In case of recalls, complaints and suspected defects: • all relevant records • described in SOP 7.18.

  13. Contract Activities 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?

  14. Contract Activities 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

  15. Contract Activities Possible Issues – II • Contract acceptor does not have all specified equipment • Contract acceptor uses incorrect equipment • Contract acceptor does not follow agreed procedures

  16. Contract Activities Possible Issues – III • Contract acceptor uses an alternative material supplier • Contract acceptor working with out-of-date specifications

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