21 Cfr Quality Agreements

Iser: The FDA issued a definitive industry forecast for quality agreements with contract manufacturers in November 2016 (1). The guideline was developed in collaboration with the Centre for Drug Evaluation and Research (CDER), the Centre for Biologics Evaluation and Research (CBER), the Centre for Veterinary Medicine (CVM) and the Office of Regulatory Affairs (ORA) and outlines the FDA`s current thinking and expectations for quality agreements. It is strongly recommended that companies refer to these instructions when initiating a new quality agreement or when reviewing an existing quality agreement with a contractual body. Divergences and corrective and preventive measures (CAPA) are other potential inconsistencies. The discrepancies require both the CMO and the sponsor to understand the cause and effects of a QMS process or excursion. The primary responsibility for investigating cases must be clearly expressed in the quality agreement, as well as when and how a sponsor can participate in an investigation. Often, large pharmaceutical and biotechnology companies have formalized survey frameworks that must be applied to deviations, while the CMO can authorize alternative approaches. The ability to reconcile two different requirements is essential to avoid unnecessary disruptions downstream of the commercial supply chain. This is another example in which limiting the scope to commercial programs is a missed opportunity for the Agency. On the other hand, the new guide gives a general overview of the areas to be included in a quality agreement. It contains sections on the following, since they relate to production activities: PTE: What mistakes do companies make in the development of quality agreements? Iser: It is important that a quality agreement between a pharmaceutical company and a contract agency clearly define the roles and responsibilities of CGMP`s activities. It is equally important, as the FDA guidelines state, “that quality agreements cannot be used to delegate legal or regulatory responsibilities for compliance with PMCs.” It is likely that the FDA would cite a company because it deviates from the expectations of the CGMP, because it respects an under-quality agreement that violates the principles of the BGP.

It is important to consider these and other recommendations in the current guidelines when developing and implementing agreements with contracting agencies.