Eudralex Quality Agreements


PharmTech: How should quality agreements be organized? Companies wishing to develop combined products should: The impact of the 21 current Part 4 (9) CFR items on their quality assurance system and operation, and they should read the FDA`s current guidelines on requirements for mixed-board products (4), since the guidelines contain the language of quality agreements, «quality agreements that may indicate, for example, what activities will be conducted, what documentation will be developed and updated to demonstrate compliance with certain requirements of the PMPC … for example, an owner may enter into a production contract for the final combination with a custom manufacturing plant and explain in supplier agreements the responsibilities and approaches of the CGMP for that facility. Iser: In accordance with the FDA`s current guidelines on quality agreements, «quality agreements can be verified during inspections,» and the rules in the United States and Europe, as well as in other regions, include expectations for outsourcing manufacturing activities. Therefore, companies that are audited by a regulatory authority should have all applicable quality agreements so that they can be made available to the examiner/inspector upon request. PTE: How can pharmaceutical companies and subcontractors enter into quality agreements that clearly describe the responsibilities of each company? Pharmaceutical Technology asked Siegfried Schmitt, Senior Advisor at PAREXEL, about the importance of quality agreements in the sponsor-contracting relationship. PTE: Do regulators want to see copies of quality agreements during inspections? Iser: It is important that a quality agreement between a pharmaceutical company and a contract agency clearly define the roles and responsibilities of CGMP`s activities. It is equally important, as the FDA guidelines state, «that quality agreements cannot be used to delegate legal or regulatory responsibilities for compliance with PMCs.» It is likely that the FDA would cite a company because it deviates from the expectations of the CGMP because of compliance with an under-quality agreement that violates the principles of the GMPs. Iser: Although a pharmaceutical company (or a sponsor or market authorization) is ultimately responsible for ensuring that products available for healthcare and care companies meet quality and safety expectations, ensuring the quality and safety of products and ingredients manufactured in a contract facility is a shared responsibility between the pharmaceutical company and each licensed facility. Both parties must meet the expectations set out in the relevant rules and guidelines to ensure that products are manufactured in accordance with current good manufacturing practices (CGFs), meet the required quality standards, and are safe and effective throughout the product lifecycle. PharmTech: What are the mistakes made by pharmaceutical companies in the development of quality agreements? PTE: Can you give a practical example when the lack of a quality agreement or a poorly written quality agreement has led to an FDA 483 and/or warning letter? Iser: There are a number of important aspects to quality agreements between a pharmaceutical company and a contract manufacturer.

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