Active pharmaceutical ingredient concurrent validation allowed in draft GMP guidance.
This article was originally published in The Tan Sheet
Executive Summary
API CONCURRENT VALIDATION PERMITTED IN FDA DRAFT GMP GUIDANCE recently released by the agency. The most recent draft of FDA's guidance, "Manufacturing, Processing or Holding Active Pharmaceutical Ingredients," permits concurrent validation for APIs involved in clinical trials. The document is available on FDA's Web site (www.fda.gov). Written comments will be accepted by the agency through May 18.