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Showing posts from July, 2020

Process validation

Process validation   Process validation can be defined generally as a series of activities taking place over the life cycle of the product. The validation exercise establishes scientific evidence that a process is capable of robustly delivering a quality product. After 24 years the FDA modernized its process validation guidance in 2011. The changes were consistent with trends in place within the pharmaceutical industry. The views changed from validation being a point in time event to being applicable over the product life cycle. The life cycle approach to drug product management is laid down in ICH Q7. Pharmaceutical Quality Systems   The FDA describes process validation as taking place in three stages. Process design Process qualification Continued process verification Process design Process qualification and continued process verification these stages align with the first three product life cycle phases to find an ICH Q7 Product development, technology transfer and