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. Service quality agreements define the quality conditions of services provided at a production site and used in the manufacture of products. 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. At least a quality agreement should define each party`s obligations and responsibilities in the following basic elements mentioned in the guidelines: first, it is important to note that the new guidelines reflect the FDA`s current thinking on commercial production relationships and not on research and development and apply to the following categories: human drugs, veterinary drugs, certain combined products, biologics and biotechnology products, finished products, APIs, drugs, in-process materials and pharmaceutical ingredients. The guidelines do not apply to the following types of products: Type A medical items and medical foods, medical devices, dietary supplements or human cells, tissues or cellular or tissue products regulated in accordance with Section 300 of the Public Health Service Act and 21 CFR Part 1271. Implementation of a quality written agreement can facilitate compliance with the CGMP, and in particular with 21 CFR 211.22 (d), which stipulates that the activities and procedures of the quality unit must be written down. The FDA recommends that owners and contract organizations enter into a written quality agreement to describe their respective roles, responsibilities and activities related to the CGMP in drug manufacturing. With this final guide, the FDA has clarified its scope, particularly with respect to the parts to which it applies. You will find a detailed context on this topic in our blog post on the draft guidelines (here). PTE: What mistakes do companies make in establishing quality agreements? 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. PTE: What are the FDA`s expectations for quality agreements? On the other hand, the new guide gives a general overview of the areas to be included in a quality agreement.
It contains sections relating to manufacturing activities: a real example of compliance [FDA] 483 under quality agreements is a contract verification body that indicates that it does not comply with a quality agreement on the destruction of the remaining samples, with the approval of the contracting entity. This relates to the importance of defining clearly defined roles, respecting roles within an agreement and matching CGMP`s expectations. PTE: What are the main aspects of a quality agreement? A quality agreement should indicate which party will determine the specifications of the components and which party will define procedures for reviewing, qualifying and tracking component suppliers. It is also necessary to determine who will perform the tests or samples necessary to comply with the PMCs. Iser: Although a pharmaceutical company (or an application sponsor or market authorization) is ultimately responsible for making available products available to patients and nurses meeting quality and safety expectations, ensuring the quality and safety of products and ingredients manufactured in a contract facility is a shared responsibility between the pharmaceutical company and each licensed facility.