What Is A Quality Agreement Pharmaceutical

According to the FDA, a quality agreement is a comprehensive written agreement between the parties involved in contract manufacturing that defines and determines each party`s manufacturing activities with respect to GMP compliance. The agreement should clearly indicate whether the owner or the procuring entity (or both) carries out certain CGMP activities. (1) It is important to take into account these aspects, as well as other recommendations contained in the current guidelines, in the preparation and implementation of agreements with contracting bodies. Iser: There are common mistakes that happen when companies create quality agreements. First, the roles and responsibilities of the pharmaceutical company and the contract manufacturer are not always clear, especially when it comes to explaining and agreeing on the responsibilities of the quality unit. Second, some agreements are interpreted in a way that deviates from GMP expectations (e.g.B. interprets a contract manufacturer that they do not have to investigate a result they produce outside of specification, since the pharmaceutical company is responsible for releasing commercial batches), which can lead to observations cited during an inspection. Thirdly, a mechanism for regular evaluation and, where appropriate, revision of the agreement is not always included in the agreements. Finally, some quality agreements contain contractual or commercial commercial aspects and should focus only on quality management aspects as defined in applicable regulations such as the US Code of Federal Regulations (CFR) 211(5) or guidance documents such as ICH Q7(3) or Q10(6). For more useful information on how to avoid these mistakes, check out the FDA`s latest industry guidance (1). A sufficiently detailed quality agreement can help avoid assumptions that lead to compliance errors. While a quality agreement defines the specific quality parameters of a project and which parties are responsible for their execution, the level of detail varies depending on the development phase of the project. At the very least, a quality agreement should delineate the obligations and responsibilities of each party into the following building blocks mentioned in the guidelines: PTE: What are the FDA`s expectations for quality agreements? One of the elements of the CMO commitment that has been hotly debated in industry is the Quality Agreement which, in the new guidelines, “defines and establishes a comprehensive written agreement between the parties involved in the manufacture of contracted medicinal products that defines and establishes the manufacturing activities of each party with regard to GMP compliance”.

While CMOs take on a much larger share of the responsibility for development – moving towards CDMOs – many questions have been raised about the content and timing of quality agreements. In fact, the value of highly customized quality agreements has been a point of discussion. Let`s look at the FDA`s new guidelines with that in mind. A quality agreement is established primarily by quality control or quality assurance representatives of each of the parties, and legal advice may not always be sought. However, there are a number of legal issues to consider when creating or reviewing a quality agreement. PTE: How can pharmaceutical companies and contract manufacturers enter into quality agreements that clearly define the responsibilities of each company? Another big problem with the manual is its lack of specificity. The discussion on the applicability of the ICH Q7, Q9 and Q10 international best practice standards tends to remain at a high level, rather than highlighting the key elements of the international guidelines that need to be addressed. .