Iser: The European Commission has published a review of the European Union`s Good Manufacturing Practices (GMP) (Chapter 7) (2) with effect from 2013, in order to provide expectations for subprocessed activities regulated by GMP. The revised GMP guide contains many of the same themes contained in the FDA`s current industry guidelines, including the roles and responsibilities of the client (of the pharmaceutical company) and the contractor (the contracting body), the evaluation of an agency responsible for carrying out outsourced activities, the disclosure of information necessary to carry out the outsourced activities, the expectations for control of changes. Etc. A company wishing to enter into a quality agreement should use this guide. Whenever a contractor is used – from a low-wage manufacturing organization to a test lab – there should be a quality agreement. The issues to be addressed in a quality agreement include all aspects of a project that affect the identity, quality, safety, efficiency and purity of a product. It also covers areas that may affect the contractor`s or client`s compliance status. Quality agreements are expressly requested by the EU and the FDA; If you are doing business in another region, it is a good idea to implement a quality agreement, even if it is not a regulatory requirement. PTE: What are the FDA`s expectations for quality agreements? A quality agreement should include at least the following paragraphs: 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). On the other hand, quality agreements do not include terms and conditions, confidentiality, price and costs, terms of delivery, limits or damage, or forecasts.5 A real example of compliance [FDA] 483 related to quality agreements is a contract verification body that is held responsible for not following a quality agreement on the destruction of the remaining samples with the approval of the awarding entity. This relates to the importance of defining clearly defined roles, respecting roles within an agreement and matching CGMP`s expectations. The following are best practices and potential elements that can be included in a quality agreement: The Q10 Pharmaceutical Quality System Industry Guide recommends that the owner, as a member of a pharmaceutical quality system, ultimately be responsible for ensuring that there are “processes to ensure control of outsourced activities and the quality of materials purchased.” It stresses that these processes should include quality risk management and include critical activities, such as.B.: the agreement should clearly define routine, escalation and emergencies and how they are treated.