Robert Iser of PAREXEL Consulting answers questions about regulatory expectations regarding quality agreements and how companies can guarantee the quality and safety of their products. It is therefore reassuring to see that the final guidelines take a more measured approach. According to the final guidelines, an “owner” includes, for the purposes of the guidelines, only “manufacturers of APIs, pharmaceutical substances, process materials, finished pharmaceuticals, including biologics, and combination products.” As with the design, the FDA excludes from the definition of an owner retail pharmacies, pharmacies, supermarkets, discounts, or other retailers who purchase finished drugs for sale in stores. The final guidelines also specify that they “are companies that produce exclusively as part of the distribution of medicines (e.g.B. Traders, brokers, sellers of own brands, distributors of own brands)”, are not included in the definition of an owner. The FDA always encourages these companies to use quality agreements or general concepts of quality agreements when it would be useful for these companies to have such an agreement. When in doubt, the FDA states that it “does, however, focus on the roles and manufacturing activities of the owner and the contract establishment.” In short, the FDA expects “owners” to enter into quality written agreements with “contractual entities” in which the parties will define and define the roles and responsibilities of each party to ensure that drugs and pharmaceuticals are manufactured in accordance with current good manufacturing practices. These quality agreements ideally indicate which party carries out which activities and which party is primaryly responsible for full compliance with the GTC in accordance with Section 501(a)(2)(B) of the Act and 21 C.F.R. 210, 211 and 600-680, which may apply to the product or substance in question. PTE: Can you give an example of the practice when the lack of a quality agreement or a poorly written quality agreement has resulted in an FDA 483 and/or a warning letter? On the other hand, the new guidelines give a general overview of the areas to be included in a quality agreement. It contains sections on the following that relate to manufacturing activities: a quality agreement should indicate which part defines component specifications and which part defines processes for auditing, qualifying and monitoring component suppliers. It should also be determined who carries out any tests or sampling necessary to comply with the CGMP.
. . .