FDA Issued Revised Guidance for OOS: What's Changed?
By Kimberley MacLean, CQA, Meridian BioGroup
A recurring theme in FDA Form 483 inspection observations and Warning Letters is the inadequate investigation of out-of-specification (OOS) results by pharmaceutical manufacturers and testing laboratories. The FDA has recently (May 2022) issued a revised guidance for investigating OOS results, Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production, which replaces the earlier guidance issued in 2006. The new revision updates terminology and clarifies the Agency’s expectations for addressing outlier results and averaging OOS results. An overview of the specific changes from the 2006 to the current version are listed in the table below:
The revised guidance document provides manufacturers and testing laboratories that support drugs regulated by CDER with more clarity on how to manage the data obtained during the OOS investigation, along with the overall investigation process itself. Further, it will likely prove to be a powerful tool that, when applied correctly, helps to ensure that drugs that are tested and released meet all required specifications.
Read the full guidance, here:
Contact us at Meridian BioGroup if you have any questions as you get familiar with this new issued guidance. Message us on LinkedIn or Email: [email protected]