Annex 08 – Sampling of Starting and Packaging Materials – 2020
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