Dr Thomas Fürst, Boehringer Ingelheim Pharma, Germany
Dr Wolfgang Grimm, Germany
Dr Cornelia Nopitsch-Mai, Quality Assessor, Germany
Dr Jordi Ruiz-Combalia, Audit GMP, Spain
Dr Thomas Uhlich, Bayer, Germany
This Live Online Training is intended to provide information on different aspects of stability testing.
The event 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. Furthermore, stability testing for drug products and a risk based approach for stability testing covering different climatic zones are presented. In addition, the specific challenges of data evaluation will be addressed.
Analytical methods that were not “stability-indicating” are frequently cited in FDA 483s and Warning Letters. This Live Online Training 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.
This Live Online Training 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.
During the Q&A sessions, 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.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
09.00 – 09.15 h
09.15 – 10.45 h
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
10.45 – 11.00 h
11.00 – 12.00 h
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
12.00 – 13.00 h
13.00 – 14.00 h
Stability Testing for Drug Substances
- Stability protocols
- Stress testing
- Photostability testing
14.00 – 14.15 h
14.15 – 15.15 h
Stability Testing for Drug Products
- Strategy of Stability Testing
- Performance of new Drug Products
- Related Finished Products with existing substances
- Follow-up Stability Testing
15.15 – 15.30 h
15.30 – 16.30 h
Evaluation of Stability Results – Statistical Considerations
- Sample number and replication
- Trend analysis
- Pooling of batch data
- Shelf life prediction