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Setting Specifications and Acceptance Criteria
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Stability Testing for Drug Substances and Drug Products
Save EUR 600,- and book both Conferences!
24-26 November 2008
Copenhagen, Denmark
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Setting Specifications, 24-25 November 2008
This Conference covers all aspects of specifications for Active Pharmaceutical Ingredients (APIs = Drug Substances), biological substances and pharmaceutical drug products from an analytical and a registration perspective.
In the development of new pharmaceutical products it is a great challenge to establish meaningful and reasonable specifications, which are scientifically sound and appropriate for APIs (chemical and biological drug substances), excipients and drug products. According to ICH Guideline Q6A, a specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described.
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. And when an applicant has to change any specification(s) for a product that is already on the market, the ‘variation’ (EU wording) or ‘change’ (US wording) has to be notified or applied for before the change can be implemented for keeping regulatory compliance.
Stability Testing, 25-26 November 2008
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. The conference is rounded off by a presentation on stability testing of biological and biotechnological products. |
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