The FDA's warning letter is a good way to understand how the FDA treats GMP deficiencies**. In a recent warning letter, the FDA commented on a company's deficiencies in process validation. What "CAPA" measures does it require for this verification flaw?
According to 21 CFR 211100, the FDA criticized the company for inadequate process validation. All of the company's initial process validation studies (e.g., process performance qualification, PPQ) were not completed. The FDA concluded that the company could not ensure that the drugs it produced met the established quality requirements.
The manufacturer "reviewed" all of the investigative materials and responded to the matter, but its response was inadequate for the FDA. The authorities have requested the development of detailed instructions to regulate how the information collected will be evaluated. FDA also expects manufacturers to compare this information with appropriate, predefined acceptance criteria in the protocol. The goal should be to be able to demonstrate that the process is repeatable and therefore the product is qualified. This work should be done in conjunction with the current plant, facilities, equipment, personnel, controls, and predictable variables in production activities.
In addition, in the sense of CAPA measures, there is also a need to carry out a risk assessment of products that have already been produced and put on the market. In addition, there is an ongoing process validation. In the validation report, you should specify the content restrictions on the final product. And vendors should investigate the many out-of-specification results found during the validation process.
Specifically, the FDA requires manufacturers to provide:
A detailed summary of the product life cycle verification program and the corresponding written requirements.
l Process performance verification schedule for each product.
Include a detailed written description of ongoing process validation of intra- and inter-batch variations.
l Process performance protocols for sites and equipment, as well as corresponding validation procedures.
l Performance verification plan for site and equipment.
Due to a number of other deficiencies, the FDA recommended that the inspected company bring in a GMP consultant.