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Contract Production and Analysis

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

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Contract Production and Analysis

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

  2. Contract Production and Analysis Objectives • To review general issues • To understand the responsibilities of: • Contract giver • Contract acceptor • To understand the contract

  3. 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: • Each party's duties and responsibilities including audits • Clearly state how the authorized person, when exercising his or her full responsibility, releases each batch or issues certificate of analysis 7.1 – 7.4

  4. 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 7.5

  5. Contract Production and Analysis 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 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 7.6 – 7.7

  6. Contract Production and Analysis Responsibilities of the Contract Acceptor (1) • Must have a manufacturing authorization • Competence: • Have the necessary facilities, premises and equipment to undertake the work • Staff should have the necessary qualifications, knowledge, training and experience to be able to do the work 7.8

  7. 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) 7.9 - 7.10

  8. 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 7.11 - 7.14, 7.17

  9. 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 7.15, 7.17

  10. Contract Production and Analysis The Contract (3) 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 7.16

  11. 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. 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. 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. Contract Production and Analysis Possible Issues – III • Contract acceptor uses an alternative material supplier • Contract acceptor working with out-of-date specifications

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