Establishment of out-of-trend limits for Stability Testing
Joachim Ermer Overview:
The identification of adverse trends is very important for stability studies, as these may impact the establishment of shelf-life or retest periods in case of submission studies, or may even result in out-of-specification batches before the defined shelf-life when batches already marketed are involved (ongoing stability studies). Therefore, prevention of the latter is an important regulatory expectation.
In contrast to out-of-expectation results in case of a constant target (release testing, product or control sample monitoring), out-of-trend (OOT) stability results pose the complication that usually a stability trend is immanent for pharmaceutical products.
Why you should Attend:
The participants will learn various approaches and statistical tools to identify suspect results in stability studies and how to establish corresponding control limits, which take the “normal” stability trend into account.
Areas Covered in the Session:
- Regulatory requirements (CFR, MHRA, EU-GMP-Guide)
- Impact of OOT-results for stability studies (ICH-studies, ongoing stability)
- Introducing a second dimension (“normal” stability trend)
- Establishing OOT limits (regression control chart, slope control chart, time-point method, cluster approach)
- Benefits of a systematic stability trend analysis
Who Will Benefit:
- Analysts, lab supervisors and managers in analytical development, Quality Control, and Quality Assurance responsible to perform submission and ongoing stability studies or to assess stability 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).