A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. In 2011, when FDA revised its process validation guidance (1), it introduced the idea that validation must continue throughout the lifetime of a pharmaceutical product. FDA advocated three stages: Process design, using the principles of pharmaceutical quality by design (QbD) Process performance qualification (PPQ) Continued process verification (CPV). Click Here For Complete Abstract Text
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