Agreement To Provide Quality Assurance

The speed of innovation and competition in the life sciences is relentless. This is prompting more and more companies to adopt light asset operating models, which rely heavily on an ecosystem of order manufacturing organizations (CMOs). 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). A sufficiently detailed quality agreement can help to avoid assumptions leading to conformity errors. 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. To learn how to optimize the coordination of quality agreements and other order manufacturing functions with digital tools, read the TrendBrief „3 Ways Contract Manufacturing Organizations Are Looking to Digital Technology to Improve Collaboration“. The FDA`s current position on quality agreements is set out in the „Contract Manufacturing Arrangements for Drugs: Quality Agreements“ guidelines published in 2016. The guidelines explicitly state that manufacturing activities are the most important element of a quality agreement.

It highlights the seven most critical areas that should be the subject of a quality agreement and their specific implications in terms of quality and change control. If a separate control laboratory is involved, all relevant roles and responsibilities must be defined. The quality agreement should explicitly specify what data is shared and how it is disseminated. According to the FDA, a quality agreement is a comprehensive written agreement between the parties involved in the manufacture of the market, which defines and defines the manufacturing activities of each of the parties with respect to CGMP compliance. . . .

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