Process Analytical Technology in Product Development and its Impact on Pre-approval Inspections

Process Analytical Technology in Product Development and its Impact on Pre-approval Inspections
NIR/PAT
Walter Dziki, Ph.D. Abbott Laboratories

The release of the Food and Drug Administration's (FDA) guidances on process analytical technology (PAT) - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance [Ref 1] and the Pharmaceutical cGMPs for the 21st Century - A Risk Based Approach [Ref 2] in September 2004 have ushered in a whole new approach to pre-approval inspections (PAIs) in the pharmaceutical industry. By implementing PAT, pre-defined trials and experiments are no longer necessary to define product quality. Rather, consistent and predictable drug product quality will be demonstrated by using current or new technology, formal experimental design and/ or prior knowledge to gain understanding and scientific knowledge of the active pharmaceutical ingredient (API) and drug product manufacturing. This science driven risk-based approach relies on communicating greater scientific understanding of the API and the drug product to increase the probability of producing a high quality drug product, thus reducing the risk of inconsistent quality. This approach will alleviate concern about producing a product with a significant risk to public health.