Stability Testing for Drug Substances and Drug Products - Online Training Recording
Course No. 21468
Speakers
Dr. Cornelia Nopitsch-Mai
formerly Quality Assessor
Dr Thomas Uhlich
Bayer
Dr. Josef Hofer
exdra
Dr. Thomas Fürst
Boehringer Ingelheim
Dr Ulli Backofen
Boehringer Ingelheim
Dr. Heiko Brunner
Hamburg
Objectives
This Live Online Training 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.
Background
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.
Target Group
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. 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.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration: When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate: The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Programme
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
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
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
Outliers
Pooling of batch data
Shelf life prediction
Recording from 07 and 08.12.2023 Duration of the recording: approx. 7 hours 15 minutes
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more
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