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GMP News
5 May 2006

WHO Guidelines on GMP-Compliant Sampling

The WHO has published two interesting documents on sampling:

The first one is "Annex 2 Good Manufacturing Practices: Requirement for the Sampling of Starting Materials". This annex was included because the European GMP regulations - especially Annex 8 to the EU GMP Guide - allow for the reduced sampling of starting materials. This means that, in certain circumstances, it is not mandatory to collect a sample of each incoming batch of a starting material (be it an API or an excipient). In its own annex, the WHO took over the exact wording of the corresponding section of Annex 8.

The second document is "Annex 4 WHO Guidelines for Sampling of Pharmaceutical Products and Related Materials". This guideline is primarily directed at representatives from authorities, among others inspectors. However, it is pointed out that the general procedures described could also be of interest to pharmaceutical manufacturers.

In fact, it is a very comprehensive guideline dealing in detail with the topic of sampling. Apart from sampling of starting materials, it also contains statements on the sampling of intermediates, finished drug products and packaging materials. In connection with sampling of starting materials, the annex presents the n, p and r plans, which should be implemented depending on the expected risk of the starting material in question.

The additional appendices are also interesting. They describe among others:

  • Sampling tools with illustrations
  • Form template for sampling documentation
  • Several sampling containers
  • Text blocks for sampling SOPs

The complete document including the two annexes can be found here:
(Annex 2: pages 38 39)
(Annex 4: pages 59 93)

Sampling as well as reduced sampling and reduced tests for incoming APIs and starting materials are among the focus topics of the GMP Education Course Quality Control of Pharmaceutical Raw Materials (APIs and Excipients) taking place in  Barcelona from 19-20 June 2006.
Dr Gnter Brendelberger
On behalf of the European Compliance Academy

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