FDA’s 2011 Process Validation: General Principles and Practices guidance created a systemic shift in industry’s approaches to validation programs. The authors describe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation.
In January 2011, FDA published its long-awaited guidance for industry on Process Validation: General Principles and Practices (1). For many in the pharmaceutical industry, the guidance created a systemic shift in the expectations of their validation programs. Although the new guidance aligns process-validation activities with the product life-cycle concept and with existing harmonized guidelines such as the International Conference on Harmonization’s Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System, it may have created as many questions for the industry as it has answered. In this article, the authors briefly describe the three-stage approach to validation that is outlined in the new guidance as well as implications for manufacturers regarding their current approaches to process validation. Specific emphasis is placed on questions surrounding industry implementation.