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). Part of the agreement should take into account a specific reflection on the different products. In addition, it is necessary to define how owners pass on knowledge, such as . B, from product and process development information to contract entities to ensure that manufacturing is geared towards CGMP.
A quality agreement does not excuse any of the convention organizations, cGMP or other regulatory requirements, even if these requirements are not specifically taken into account as part of the agreement. Quality agreements are an important tool for managing the complex supply chain used in contract drug manufacturing and ensure that these drugs have the quality, safety, purity and effectiveness required by CGMP regulations. A quality agreement should include at least the following paragraphs: a reasonably detailed quality agreement can help avoid assumptions that lead to compliance errors. However, while a quality agreement defines the specific quality parameters of a project and the parties responsible for their implementation, the degree of detail varies depending on the stage of development of the project. A quality agreement should at least define the obligations and responsibilities of each party in the following basic elements mentioned in the guidelines: supplier and supplier quality agreements define the quality conditions of materials or services provided at a production site and used in products or product manufacturing.