Sample Documents for Participants in the Seminar Validation of Analytical Test Procedures

Time and again we are asked for sample documents for the GMP-regulated environment. Therefore, participants in the ECA events "Measurement Uncertainty" and "Validation of Analytical Test Procedures" in Copenhagen from 12-15 October receive concrete examples in the form of a brochure as part of the event documentation. The documents were created by the German Medicines Manufacturers Association and are now available in English.

The International Conference on Harmonisation, ICH, published the guideline "Validation of Analytical Procedures: Text and Methodology. Q2(R1)" on this subject, which was then adopted as the Note for Guidance CPMP/ICH/381/95 at the European level. This guideline describes the current regulatory requirements on the validation of analytical procedures. However, detailed instructions on the practical implementation of the regulations can be found in this document only to a limited degree. This is where the manual steps in to offer further guidance to the users - medicinal product manufacturers, service providers and authorities - with a large number of practical examples.

The manual includes among other things concrete case studies on the topics:

  • The use of relative response factors in the determination of impurities
  • Cross-validation and revalidation for different changes to the analytical procedure, to the manufacturing process or to the specifications
     Validation of dissolution tests
  • Development of a dissolution procedure
  • Validation plans for the assay of active substance release

and many others more.

Detailed information on the individual chapters and the topics described in them can be found in the PDF file of the manual's table of contents. For more specifics of the event whose participants receive the manual please go to "Measurement Uncertainty" and "Validation of Analytical Test Procedures".

Dr Gerhard Becker
On behalf of the European Compliance Academy (ECA)

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