In new guidance, Process Validation: General Principles and Practices, the FDA updates the venerable Guideline on General Principles of Process Validation published in 1987. The regulator says the revision includes its current thinking on process validation while remaining consistent with the 1987 principles.
The recommendations are in line with the FDA's endorsement of a risk-based approach to drugmaking, says the agency. And the guidance aligns process validation activities with product lifecycle concepts as well as international harmonization guidance documents (FDA/ICH Q8, 9 and 10).
The 19-page document, released this month, covers the three validation phases: process design, process qualification and continued process verification. It highlights differences between traditional and PAT processes. CDER took the lead on the update, with help from CBER, the Office of Regulatory Affairs and the Center for Veterinary Medicine.
In one example of how drug regulation has changed over the last 24 years, the revision includes a recommendation that calls for a statistician with training in process control to be the developer of procedures for evaluating process stability and capability. By contrast, the word "statistician" appears nowhere in the 1987 document.
In addition, "We recommend that the manufacturer use quantitative, statistical methods whenever appropriate and feasible," the guidance says. "Scrutiny of intra-batch as well as inter-batch variation is part of a comprehensive continued process verification program."