Compliant Management of Out-Of-Specification Results (OOS
Joachim Ermer Overview:
Out-of-specification (OOS) test results and their appropriate management is a (literally) “vital” topic in pharmaceutical Quality Control and inevitably in the focus of any inspection and audit. Although the FDA-Guidance on OOS-results provides detailed instructions how to manage results outside specification, observations and deficiencies dealing with OOS results is still a major issue in inspections, FDA 48’s3 and Warning Letters. Inappropriate OOS-management may result in comprehensive retrospective investigations and remediations and may consume large resources.
Why you should Attend:
Participants will get an overview on regulatory expectations, which are mainly based on the FDA Guidance for Industry “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production”, as well as practical recommendations for an efficient and GMP-conform investigation. Of course, “prevention is better than cure”. For this purpose, it is important to avoid OOS-results, for example by means of a suitable identification and control of atypical or out-of-trend (OOT) results.
Areas Covered in the Session:
- The importance of clear definitions and terminology (reportable result, OOS, OOT, OOE, re-analysis, retest, resampling, etc.)
- Phase I: Initial laboratory investigation
- Phase II: Full scale investigation (Phase IIA: Review in production, Phase IIB: Additional laboratory testing (retests, averaging)
- Averaging, variability and OOS
- Reporting and documentation
- Appropriate response to OOS observations in inspections
- Prevention of OOS results (sample suitability acceptance)
Who Will Benefit:
- Analysts
- Lab Supervisors and Managers in Quality Control,
- Quality Assurance, and inspection functions responsible for investigation or assessment of OOS results.
Speaker Profile
Dr. Joachim Ermer is a biochemist with 30 years of experience in pharmaceutical analytics, including development products at Hoechst AG, global responsibilities as Director of Analytical Processes and Technology at Aventis, and head of Quality Control and head of QC Lifecycle Management Frankfurt Chemistry at Sanofi. From 2010 till 2020, he was also responsible for the central reference standard group and Global Reference Standard Coordinator of Sanofi. Since December 2020, he serves as consultant for topics of pharmaceutical analytics and Quality Control. Joachim Ermer is member of the USP Expert Committee “Measurement and Data Quality“, of the Ph.Eur. Working Group “Chromatographic Separation Techniques”, and Advisory Board member of the ECA Analytical Quality Control Group.
He authored more than 60 publications on analytical topics and contributed to the USP General Information Chapter <1220> as well as other Stimuli Articles. He is editor and author of the book “Method Validation in Pharmaceutical Analysis. A Guide to Best Practice” (Wiley-VCH, 2005, 2015, 2024).