Setting Specifications and Acceptance Criteria 24-25 November 2008 Copenhagen, Denmark Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1290,--) Book this option: ECA Members (EUR 1161,--) Book this option: EU GMP Inspectorates (EUR 645,--) Book this option: APIC Members (does not include ECA membership) (EUR 1225,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Setting Specifications and Acceptance Criteria - How to Achieve Regulatory Compliance for APIs, Biological Substances and Drug Products Objectives/Background 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.