Dr Ulli Backofen, Boehringer Ingelheim, Germany
Dr Thomas Fürst, Boehringer Ingelheim, Germany
Dr Wolfgang Grimm, Germany
Dr Josef Hofer, EXDRA, Germany
Dr Cornelia Nopitsch-Mai, Quality Assessor, Germany
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, important aspects of stability testing for biologicals and throughout drug development are discussed. The second day commences with a lecture on stability testing for Drug Substances, followed by a talk on Drug Products and a risk based approach for stability testing covering different climatic zones. In the following presentation, the focus lies on to the various aspects of submitting stability data. The specific challenges of data evaluation and typical questions from authorities will also be addressed. Finally, statistical considerations will be covered in another lecture.
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.
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 for Biologicals
- Overview of regulatory requirements
- Types of stability studies for Biopharmaceuticals
- Practical aspects of stability studies with Biopharmaceuticals
- Degradation pathways
- Setting shelf life during early and late stage development
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
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
- Regulatory Strategy Stability
- Drug Substance and Drug Product Stability Data and Evaluation
- Storage recommendations/labelling/SmPC
- Stability studies, commitments post approval
- Typical questions from authorities and answers
Evaluation of Stability Results – Statistical Considerations
- Sample number and replication
- Trend analysis
- Pooling of batch data
- Shelf life prediction