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Vendor Quality Agreement

Manufacturing quality agreements are comprehensive written agreements between parties involved in the manufacture of medicines, which define the manufacturing activities of each party with respect to how each party will comply with the GTCPs. 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. If you use QMS to extend compliance responsibilities to suppliers, your agreement should clearly clarify expectations for its participation. Quality agreements help both parties in the overall contract analysis process. They define, establish and document the roles and responsibilities of all parties involved in the process. Quality agreements allow each party to define its expectations and rules for projects and to ensure that the quality characteristics of both parties are consistent and that each party receives effective quality services and products. 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. It is important that you define all the terms used in the supplier`s quality agreements to avoid further confusion. This includes a clearly defined perimeter that ensures that both parties are aware of what is contained. 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. These positions are included in the delivery contract, which is separate proof. The quality agreement may be included by reference in the delivery agreement. If both documents are established as a single document, the whitelist may contain people who have no reason or no time to check for issues that have nothing to do with their area of expertise. 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.

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. The Supplier Quality Agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and GMP (Good Manufacturing Practice) obligations of the design owner and supplier. . . .

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