Annex 08 – Sampling of Starting and Packaging Materials – 2020

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Sampling is an important operation in which only a small fraction of a batch is taken. Valid conclusions, on the whole, cannot be based on tests which have been carried out on nonrepresentative samples. Correct sampling is thus an essential part of a system of Quality Assurance.

This very short but important interactive e-Learning / Online GMP training Annex 8 module introduces the user to the GMP regulations relating to the sampling of starting and packaging materials.

The objectives of this training module are:

  • to understand personnel training requirements and responsibilities
  • to understand the requirements relating to validation of the sampling process
  • to understand sampling considerations