Destin A. LeBlanc

Cleaning Validation Technologies

Technical Consulting Services

SEPTEMBER 1995

What is the FDA's current policy with respect to validation of bulk pharmaceutical chemical processes?

FDA expects manufacturers to be actively engaged in a validation program for all of their BPC products, although we have not insisted that validations be completed at this time.  This agency policy is delineated in the referenced Compliance Policy Guides.   FDA will consider withholding approval of new drug applications based on the lack of process validation when (1) a company has not established or is not following an adequate plan to validate all BPCs; or (2) there is evidence that the process is not validated as demonstrated by repeated batch failures due to manufacturing process variability not attributable to equipment malfunction or operator error.

Reference:  Compliance Policy Guides 7132c.08  and 7125.38 (Process Validation Requirements for Drug Products Subject to Pre-Market Approval).