Good Manufacturing Practices (GMPs) are a critical component to the overall regulatory environment of a dietary supplement laboratory and understanding how to implement a strong quality system based on scientifically sound analytical and/or microbiological techniques is key.  This laboratory quality system is most important when required raw material and finished product specifications for identity, purity, strength, composition, and limits on potential contaminants are not met.  When this happens, an Out of Specification (OOS) investigation must be conducted to determine whether the original OOS result is valid; and this must be accomplished in a timely, unbiased, and well-documented manner. Each OOS investigation must also be scientifically sound and thorough enough to get to the root cause of the OOS result. Appropriate Corrective and Preventive Actions (CAPAs) should then follow to ensure that the correct result is ascertained and that any errors are systematically prevented from reoccurring.  The performance of inadequate OOS investigations has historically been one of the most frequent citations on FDA issued List of Observations, more commonly referred to as Form 483s.


Presented by CHPA/EAS Consulting Group, LLC

Moderated by John Punzi, Ph.D., Quality Assurance & Technical Affairs, CHPA


Webinar Objectives
  • Learn when an OOS Investigations is required.
  • Understand the critical steps to conducting an OOS investigation.
  • Examine appropriate documentation strategies.
  • Avoid "testing into compliance" situations.
  • Learn how to identify needed CAPAs through proper Root Cause Analyses.
Seminar Information
Date Presented:
March 06, 2018 2:00 PM Eastern
1 hour
CHPA Member Price:
Non-Member Price:
Conducting a Scientifically Sound Out of Specification (OOS) Investigation
Speaker Information
Tara Lin Couch Ph.D.  [ view bio ]
Individual topic purchase: Selected
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