FDA Releases Final Guidance for Industry On Process Validation for Drug Manufacturing

The Food and Drug Administration published a final guidance for the pharmaceutical industry on the elements of process validation for manufacturing drug and biological products, including active pharmaceutical ingredients (APIs), according to a notice published Jan. 25 in the Federal Register (76 Fed. Reg. 4360).

The guidance, Process Validation: General Principles and Practices, is intended to provide clear and consistent communication of regulatory expectations and to promote voluntary compliance with current FDA requirements, the agency said. It revises and replaces the 1987 guidance for industry, Guideline on General Principles of Process Validation.

The final guidance describes ...