Sprecher
Dr Thomas Fürst, SANOFI, Biberach, Germany
Dr Wolfgang Grimm, Germany
Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany
Dr Cornelia Nopitsch-Mai, Bonn, Germany
Dr Jordi Ruiz-Combalia, Audit GMP, Spain
Dr Thomas Uhlich, Bayer AG, Germany
Dr Raphael Bar, BR Consulting, Israel
Zielsetzung
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.
Hintergrund
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.
Zielgruppe
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.
Programm
Stability Testing for Drug Substances and Drug Products
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
- Must the development stability programme meet ICH Q1A?
- Stability testing from early development to product launch
- Clinical stability for comparators
- Site specific stability
- Stability protocols
- Stress testing
- Photostability testing
- Documentation
- Strategy of stability testing
- Performance of new drug products
- Related finished products with existing substances
- Follow-up stability testing
- Drug substance stability
- Drug product stability
- Storage recommendations/labelling
- Essential hints for writing the stability part in the CTD
- Sample number and replication
- Trend analysis
- Outliers
- Pooling of batch data
- Shelf life prediction
- Stability studies after approval (EU/US)
- Changes with impact on stability
- Examples
Post-Conference Session Stability studies to support shipping/distribution of Pharmaceuticals and Biopharmaceuticals
Overview of stability programs and Stress Testing– regulatory view (GMP and GDP)
- Long-term and accelerated storage conditions of new drug substances and products (EU, USA)
- Stability storage programs for generic drugs (EU, USA)
- Stress testing vs Forced Degradations
- Stressing factors
- GDP Guides (EU, WHO, USP Chapter <1079> )
- “Time-out-of-Storage” and “stability budget“ concept
- The four Qs: DQ, IQ, OQ and PQ
- Temperature monitoring in a shipment
- Mean Kinetic Temperature (MKT) and relative humidity
- Interpretation of MKT
- MKT from temperature loggers
- Global climatic zones by ICH and WHO
- Linking storage instructions to formal stability studies
- Labeling statements for various pharmaceuticals (EMA guideline)
- USP controlled temperatures
biopharmaceuticals
- Studies at elevated extreme temperatures
- Studies at low extreme conditions
- When, how and what?
- Thermal Cyclic studies
- What attributes to test
- Handling an excursion
- What stability data are required to investigate temperature excursions
- Responsibilities of manufacturer, distributor and QP
- Estimation of degradation rates at the excursion temperature
- Estimation of degradation at the expected long-term shelf-life
- Estimation of a maximal “Time-out-of-Storage” of a drug
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