"Validation" is now a popular term and has become an essential requirement for the pharmaceutical industry. Since the 1970s, FDA had discussed the necessity of validation of drug manufacturing processes and then issued "Guideline on General Principles of Process Validation" in 1987. Moreover, European countries and Japan have incorporated validation into their regulation in 1990s. In ICH Q7A (API-GMP Guideline), the validation is discussed in chapter 12 and the DQ (design qualification) is described as well as IQ, OQ, and PQ. In August, 2002, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach" was launched by FDA. The new regulatory strategy will encourage manufacturers to develop and implement the latest technologies in pharmaceutical manufacturing processes. In this paper, regarding the API manufacturing processes, methods and techniques of the validation based on ICH Q7A and FDA's guidance are described.
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