Guidance On Contract Manufacturer Quality Agreements

To avoid any misunderstanding, a glossary defining keywords, acronyms and abbreviations is essential. It is important for everyone to know what is meant by the term used in the quality agreement. This is particularly the case for contracts with non-US companies. Parts, because the terminology can be very different. Be sure to clearly define all referenced documents. A standard operating procedure should be put in place to indicate the types of suppliers and services for which a quality agreement is required. At least an agreement must be concluded for each use of a CMO and with all suppliers of critical materials. They are recommended for suppliers of large quantities of raw materials or components. There are four types of quality agreements: manufacturing, supplier, supplier and quality of service agreements, each tailored to the relevant aspects of each type of relationship. A real example of compliance [FDA] 483 under quality agreements is a quality audit body that is cited for failing to comply with a quality agreement on the destruction of residual samples with the authorization of the contracted company. This is related to the importance of defining clearly defined roles, respecting roles within an agreement and their compliance with CGMP`s expectations. The new guidelines highlight the need to define who is responsible for installation and equipment activities that impact the production company. This includes defining who supports the qualification of facilities and equipment and the validation of processes.

It should also cover support systems for the manufacturing undertaking, including information technology and automated control systems, environmental monitoring and space classification, refuelling services and all other equipment and equipment that needs to be maintained to carry out contractually agreed manufacturing operations in accordance with cGMP. Iser: In accordance with the FDA`s current guidelines on quality agreements, “quality agreements can be verified during inspections” and current rules in the United States, Europe, and other regions contain expectations for outsourcing manufacturing activities. Therefore, undertakings that are inspected by a regulatory authority should have all applicable quality agreements in place so that they can be made available to the inspector/inspector on request. The agreement should not contain certain points such as general terms and conditions of sale, price and escalator clauses, forecasts, delivery conditions, confidentiality obligations and limitations of liability.. . . .