A Comparative Review of the USFDA Guidelines on Process Validation Focusing on the Importance of Quality by Design (QbD)

Medical disasters like Devonport incident of 1972 in Liverpool, United Kingdom, where many patients were killed due to administration of improperly sterilized dextrose infusions, led the USFDA to release its first guidance on Process Validation in 1987. However, the FDA's 1987 guidance document, Guideline on General Principles of Process Validation was replaced in January of 2011 when the FDA published the updated guidance for Industry-Process Validation: General Principles and Practices. The new guideline introduces new concepts and principles and denotes the evolution in process validation requirements. The new approach provides opportunities for a more integrated approach to process validation and across the product lifecycle. It also provides opportunities for automation of the collection, processing, and reporting of the required information. Like other guidelines, they are not law, but adherence to them provides a good framework for building a compliance program and developing a quality medicinal product.