CPG Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval

Issue Date: March 12, 2004
Issued by: Center for Drug Evaluation and Research
Topic(s):
Status: Final

CPG Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval

This guidance document represents the Food and Drug Administration’s (FDA) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicate statute and regulations.

Download the Guidance Document