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:
http://whqlibdoc.who.int/trs/WHO_TRS_929_eng.pdf
(Annex 2: pages 38 –39)
(Annex 4: pages 59 – 93)
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