As a result of this trend, the burden of complying with the current Good Manufacturing Practices Guidelines (GMPCs) is increasingly shared between the companies that own products and the contract establishments on which they depend. A strong quality agreement is the first step for both parties to be responsible and cooperate to comply with the rules imposed by the US Food and Drug Administration (FDA). “You indicate that you assume that your contract manufacturer is responsible for developing a basic manufacturing data set, exercising quality control functions and verifying that finished products meet specifications. You indicate that you assume that your contract manufacturer will comply with 21 CFR Part 111 because you do not know of any problems in the installation,” the letter states. Cooperation is essential for any successful business partnership, so it is important for owners and contractors to develop written and oral communication protocols. A quality agreement should define all manufacturing roles and activities and establish appropriate contact staff for each organization. Processes such as corrective and preventive measures (CAPA) and deviation management have the potential to create disagreements, so responsibilities related to studies and other processes related to the management of the quality event should be clearly defined in the agreement. The guidelines also stress that quality agreements should be clear as regards the release of products. Agreements with contract manufacturers would cover the basics of trade: what product is to be manufactured with, with what ingredients, when it is to be delivered and at what cost. What is really essential for full GMP compliance is a separate quality agreement that details the procedures to ensure that the product is what it is supposed to be and that it will be that way every time.
This includes all the final manufacturing data, batch production records, the examination of the finished product and, in particular, the verification of all the abovementioned points up to the snout. The FDA has written in numerous warning letters to dietary supplement companies: “While your company may order certain dietary supplement manufacturing operations, it cannot, for the same reason, assume its ultimate responsibility for ensuring that the dietary supplement it markets (or markets) is not distorted because it does not meet the CGMP requirements for dietary supplements.” In this guide, the FDA states: “Quality written agreements are not explicitly necessary under existing CGMP rules and do not relieve either party of their responsibilities under CGMP regulations or the law. . . .