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When Is A Quality Agreement Required

Iser: There are some common mistakes that occur when companies develop quality agreements. First, the roles and responsibilities of the drug manufacturer and the contract manufacturer are not always clear, particularly when it comes to explaining and agreeing on the responsibilities of the quality unit. Second, some agreements are interpreted to deviate from the expectations of the CGMP (for example.B. an ordering manufacturer interprets that they do not have to study a result that does not conform to the specifications they produce, since the pharmaceutical company is responsible for the release of commercial lots), which can lead to observations during an inspection. Third, a mechanism for periodic evaluation and review of the agreement is not always included in the agreements. Finally, some quality agreements deal with commercial or commercial aspects and should focus solely on quality management aspects as defined in current regulations, such as.B. US 21 Code of Federal Regulations (CFR) 211 (5) or guides such as ICH Q7 (3) or Q10 (6). You will find more useful information to avoid these errors in the FDA`s current industry guidelines (1). It is customary for the trade agreement and the quality agreement to contain provisions on the same subject, such as rights.

B audit or technology transfer. It is preferable that there be no duplication and that one of the documents simply refers to the provisions of the other agreement instead of repeating or repeating the same provisions. An effective quality agreement identifies specific sites where the contracting entity performs manufacturing operations, including specific services to be provided on each site. The agreement must indicate which controlled and documented changes can be made by the contractor only with notification to the owner and those that must be discussed, verified and approved by the owner before they can be implemented. 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. It should also be noted that ICH [International Council for Harmonization] Q7 (3) contains useful information on quality agreements with API production sites, which are supplemented by FDA guidelines on quality agreements.