Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Analytical validation of medicinal products in contract laboratories: From the task description to an SOP for the routine analysis - an overview ***

Dr. Wolf-Rüdiger Schlag (Abschlußjahr: 2002)

This thesis tries to give an overview on the regulatory framework concerning analytical validation in the pharmaceutical area.

It is explained, why the validation of analytical methods is important for the judgement of quality and safety of medicinal products. Furthermore, the connection to the legal requirements of validation is given.

The elements of analytical validation, which are required according to the basic guidelines (ICH Topics Q2A and Q2B) are summarised in the first part. As these guidelines are rather abstract - especially concerning the evaluation of the results - suggestions are given to set specifications for the acceptance limits of the results. Additionally several hints are given which should be considered during planning a validation.

As contract manufacturing and testing is a common practice, also the legal requirements concerning this topic are regarded. In the case of outsourcing of analytical validation and testing it is rather important (apart from the direct legal requirements) to clarify the respective tasks and expectations. For this purpose several points which should be considered are given.

To make the abstract discussion of the guidelines vivid, an example of a validation plan is presented: The HPLC-analysis of a liquid medicinal product is chosen for illustration.

This validation plan may be used as a backbone for other validation tasks. However, as every validation task has its very special requirements, the example presented should be seen critically with respect to the concrete purpose of the method to be validated. Nevertheless it should give some ideas.

Finally some suggestions are given, which points should be considered if an SOP, related to the validated method is to be written.

Pages: 40