Process Development and Design Review
Compliance to Good Manufacturing Practices and Good Engineering Practices require process development and equipment and facility design. It is assumed that one cannot validate processes or equipment or facilities that just suddenly existed without development or design. The support for these pre-build activities includes development reports and formal design review. The documents arising from development and design leave an audit trail which serves to assure regulators that the company is operating in control. These documents have a dual purpose in providing guidance to the development of validation functions and validation documents. Once you know what the process or equipment was designed to do, it is much easier to decide if it performs.
As part of an engineering design review, or a pharmaceutical process development, the activities and plans can be checked against nationally recognized and established guidelines. The purpose of any review and subsequent report is to gain assurance that the end product (process, equipment or facility) will operate and validate.
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