According to the final guidelines, an “owner” includes, for the purposes of the guidelines, only “manufacturers of APIs, pharmaceutical substances, process materials, finished pharmaceuticals, including biologics, and combination products.” As with the design, the FDA excludes from the definition of an owner retail pharmacies, pharmacies, supermarkets, discounts, or other retailers who purchase finished drugs for sale in stores. The final guidelines also state that they do not include in the definition of owner “businesses that produce exclusively in the context of the distribution of drugs (for example. B traders, brokers, distributors of own brands, distributors of own brands). The FDA always encourages these companies to use quality agreements or general concepts of quality agreements when it would be useful for these companies to have such an agreement. The guidelines do not cover the following product types: Type A drugs and medicated foods, medical devices, food supplements or human cells, tissues or cellular or tissue products regulated under Section 300 of the Public Health Service Act and 21 CFR Part 1271. Deviation and correction and prevention measures (CAPA) are other potential areas of contention. Deviations require the CMO and the Sponsor to understand the cause and effects of a process or excursion in the QMS. The primary responsibility for the study of causes 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 formalised analytical frameworks that need to be applied to derogations, while the CMO may allow other approaches.
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