One of the many important details of quality agreements is the window of opportunity. If a CMO wants a five-day rotation for checking a Master Batch (MBR) data kit, this can be useful because no data needs to be verified. However, if the CMO wants a five-day rotation for the verification of a running batch production data set (BPR), it does not make sense in most cases. There is too much data to be able to verify, to be able to do a thorough job in five days. Supplier and supplier quality agreements define the conditions relating to the quality of materials or services provided to a production site used in products or in the manufacture of products. Quality of service agreements define the conditions relating to the quality of services provided to a production site and used in the manufacture of products. It is important to understand the relationship between the quality agreement and the trade agreement. Both documents define the responsibilities of the parties with respect to the same overall activity, for example. B the activity of manufacturing products or verifying products. A quality agreement should indicate which party will define component specifications and which part will define processes for auditing, qualifying and monitoring component suppliers. It should also be determined who carries out any tests or sampling necessary to comply with the CGMP. In almost all cases of outsourcing of GMP activities, there will also be a commercial agreement on outsourced activities, such as.B.
a “manufacturing and supply agreement”. This trade agreement is usually developed by legal and business development officers and is not sufficiently detailed to comply with GMP principles. This model master document of more than 35 pages for the manufacture of a quality technical contract clearly defines the obligations of the procuring entity and the contractor and is extremely beneficial for both parties. The proposal sets out all the provisions, agreements and controls necessary to avoid any misunderstanding that could lead to a product or work of unsatisfactory quality. Quality agreements are not only good business practices, there are also regulatory requirements for them. ICH Industry Guidelines Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients recommends that owners evaluate contract facilities to ensure contractors` sites meet the CGMP for certain operations. Written agreements should also define a reflection on subcontracting. They should describe how changes in processes, equipment, methods and specifications are managed and allow the owner to verify compliance with CGMP in their supplier`s facilities. A quality agreement is a document that defines both specific quality parameters for a project and which party is responsible for executing those parameters. The degree of detail may vary depending on the development phase of the project. There are regulatory requirements for quality agreements. While this is not currently required by U.S.
SMPs for pharmaceuticals, it is very likely that they will be soon. In 2016, the FDA released the guidance document “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” Adding a quality agreement requirement to 21 CFR 211 would bring U.S. PPPs into compliance with European Union (EU) GMPs and FDA-accepted ICH guidelines (see below). If both agreements contain provisions relating to the same subject-matter, these must be carefully examined in the event that one of the agreements is subsequently amended. To avoid any misunderstanding, a glossary defining keywords, acronyms and abbreviations is essential. It is important for everyone to know what any term used in the quality agreement means.