COMPLIANCE POLICY GUIDE (CPG)
CPG Sec. 638.100 Process Validation Requirements for Drug Products Subject to Pre-Market Approval March 1995
See CPG Sec. 490.100 for Policy.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.