Manufacturing quality agreements are comprehensive written agreements between the drug manufacturing parties that define each party`s manufacturing activities and determine how each party respects the CGMP. Quality agreements are also defined in the ICH quality documents. ICH Q7, 16.12, “There should be a written and approved contract or formal agreement between a company and its contractors that specifies the responsibilities of PMPs, including quality measures, for each party.” Do you want to have the confidence to control your suppliers? Another example: if the quality agreement is “Batch Record Review, five days” requires clarification. Is it a MBR or an RPO? Is it five working days or five calendar days? These are details that can make a big difference. How about a model quality agreement that the FDA will approve? Whenever a contractor or ORGANISATION is used, including agreements between different departments of the same company, regardless of the physical location of the parties involved, a quality agreement should be reached. The agreement should cover all aspects of the project affecting the identity, quality, safety, efficiency and purity of a product. Items that may affect the contractor`s or client`s compliance status should also be included. Quality agreements should be developed by the quality assurance functions of both parties, with the participation of the operational staff involved, for example. B manufacturing and laboratory staff. They should be approved by the SQ function of both parties and by the operating department of both parties. The legal division may or may not participate in the quality agreement. The inclusion of the legal division in the preparatory phase would help to ensure that the quality agreement is in line with the delivery agreement; It may, however, delay the performance of the quality contract if the legal department wishes to add unnecessary legal formulations that do not fall within the quality agreement. The quality agreement should be developed and mutually accepted by the OCM/contractor and the customer prior to the delivery agreement, to ensure the identification of all service charges and any operating restrictions.
None of the parties should take anything for granted. A quality agreement should include at least the following sections: Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting firm specializing primarily in the manufacturing of labour-based pharmaceuticals. He has 36 years of experience in pharmaceutical insurance and manufacturing. During his career, Roger has had various director positions in Qua Read More There are regulatory requirements for quality agreements. Although U.S. GMOs are not currently needed for drugs, it is very likely that they will soon. In 2016, the FDA released the policy paper “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The addition of a quality agreement requirement to 21 CFR 211 would involve the United States.