Stability Testing for Drug Substances and Drug Products
Im Auftrag der ECA Academy

Stability Testing for Drug Substances and Drug Products Im Auftrag der ECA Academy

Prague, Czech Republic

Seminar Nr. 17382


Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Dr Thomas Fürst, Boehringer Ingelheim Pharma, Germany
Dr Wolfgang Grimm, Germany
Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany
Dr Cornelia Nopitsch-Mai, Quality Assessor, Germany
Dr Jordi Ruiz-Combalia, Audit GMP, Spain
Dr Thomas Uhlich, Bayer, Germany


This event is intended to provide information on different aspects of stability testing. The conference will be opened by an overview of stability testing with a special focus on important changes in current revisions of ICH Guidelines. In the subsequent presentations, practical aspects of stability testing for drug substances and throughout drug development are discussed.

The second day commences with a lecture on stability testing for Drug Products and a risk based approach for stability testing covering different climatic zones. In the following talks special consideration is given to the various aspects of post-marketing stability testing procedures. The specific challenges of data evaluation and the structure of the Common Technical Document (CTD) will then be addressed


Analytical methods that were not “stability-indicating” are frequently cited in FDA 483s and Warning Letters. This conference will thus address how to set impurity limits for related substances and degradation products based on method capability and stability results. Furthermore, genotoxic impurities and strategies for their control will be presented and QbD (Quality by Design) will also be discussed.

The analytical result, which will be compared to the specification, is affected by the variability of the measurement itself and depends also on the sampling process and on the variability of the manufacturing process of the tested product itself. This makes statistical considerations essential and consideration of the associated measurement uncertainties vital when setting or complying with specifications.

Finally, specifications for the API (drug substance), excipient(s) and the drug product are part of the quality section of the marketing authorisation application which has to be submitted to the competent authority.


This conference is of particular interest to specialists from QA, QC and Regulatory Affairs departments of the API and pharmaceutical industry and CROs as well as to members of the EU inspectorates and authorities. Participants have the opportunity to exchange their experiences they gained with the different aspects of ‘specifications’ with the experts from the API and pharmaceutical industry as well as with members of competent authorities.


Current ICH and CHMP Guidelines for Stability Testing
  • Overview of stability guidelines
  • Concepts of stability testing
  • Retest period and shelf-life
  • Post-marketing stability studies
  • Future activities
Stability Testing throughout Drug Development
  • Must the development stability programme meet ICH Q1A?
  • Stability testing from early development to product launch
  • Clinical stability for comparators
  • Site specific stability
Stability Testing for Drug Substances
  • Stability protocols
  • Stress testing
  • Photostability testing
  • Documentation
Stability Testing for Drug Products
  • Strategy of stability testing
  • Performance of new drug products
  • Related finished products with existing substances
  • Follow-up stability testing
Submitting Stability Data – The CTD Structure
  • Drug substance stability
  • Drug product stability
  • Storage recommendations/labelling
  • Essential hints for writing the stability part in the CTD
Evaluation of Stability Results – Statistical Considerations
  • Sample number and replication
  • Trend analysis
  • Outliers
  • Pooling of batch data
  • Shelf life prediction
Post-marketing Stability Testing
  • Stability studies after approval (EU/US)
  • Changes with impact on stability
  • Examples


GMP Seminare nach Thema

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