New Draft Guidance on Process Validation

Rockville, MD (Nov. 20)-The US Food and Drug Administration issued a draft guidance on Nov. 18, 2008, titled Process Validation: General Principles and Practices for comment. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation.

The new draft guidance, based in part on the agency’s Pharmaceutical CGMPs for the 21st Century initiative, promotes a ‘‘life cycle’’ approach that focuses on scientifically sound design practices, robust qualification, and process verification, according to the Nov. 18, 2008, Federal Register. The life cycle approach breaks down process validation into three stages: process design, process qualification, and continued process verification. The draft guidance is also aligned with International Conference on Harmonization quality guidance documents such as Q8: Pharmaceutical Development, Q9: Quality Risk Management, and Q10: Pharmaceutical Quality System.

The guidance will apply to process validation of human and animal drug and biological products, including active pharmaceutical ingredients.

Comments are due Jan. 20, 2009, and can be sent in writing to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852 or submitted electronically at www.regulations.gov.

View the full draft guidance here.