Quality agreements have been used for many years in the pharmaceutical industry to describe the responsible responsibilities that are assigned to suppliers providing GMP services such as outsourcing, packaging and distribution. Quality agreements are only used in clinical drug development to ensure that responsibilities are understood by both the contractor and the GCP service provider. The pharmaceutical and biopharmaceutical industry relies more often on quality agreements and the FDA recognizes the importance of appropriate oversight and compliance. This white paper focuses on quality agreements in the GCP world. For comments or suggestions, email us at email@example.com suppliers and suppliers quality agreements define the quality conditions of materials or services provided at a production site used in products or in product manufacturing. Service quality agreements define the quality conditions of services provided at a production site and used in the manufacture of products. Iser: The best way for pharmaceutical companies and contract manufacturers to create quality agreements that will clearly describe each company`s responsibilities is to follow the recommendations regarding the roles and responsibilities contained in the current guides. The Agency`s current documents clearly set out expectations for documenting roles and responsibilities directly related to the responsibilities of the quality unit contained in the PMCs; and aspects of the pharmaceutical quality system contained in health authority guidelines and ICH guidelines. Manufacturing quality agreements are comprehensive written agreements between the drug manufacturing parties that define each party`s manufacturing activities and determine how each party respects cmIM. A recent example of a citation of a quality contract in a letter of formal notice (7) relates to a quality agreement with the manufacturer of the company`s contract, which did not contain any provisions relating to the treatment of sterilization and other provisions relating to quality agreements that were not systematically complied with.
Although this warning letter is device-related and complies with purchasing controls in 21 CFR 820.50 (8), it also shows that the clarity of roles and responsibilities and Compliance with an approved quality agreement are important aspects that must be considered when a company develops and implements a quality agreement with a contracting body and can be evaluated while an FDA auditor is on site. The big question is: Why should the Agency provide a guide that only deals with commercial manufacturing? The role of the order manufacturer has grown over the past decade and has expanded to everything from API design to clinical logistics and pharmacovigilance.