EU GMP Annex 8 - Sampling of Starting and Packaging Materials

What it says

Sampling of starting and packaging materials must be performed by appropriately qualified and trained personnel following written procedures, with sample quantities and locations within a batch statistically and practically justified to provide a genuinely representative sample, and sampling equipment cleaned and, where appropriate, sterilised to prevent contamination.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Sampling procedure design must genuinely produce a representative sample, meaning sample location and quantity decisions require actual statistical and practical justification, not simply sampling from whatever container is most physically convenient to access.
• Personnel qualification for sampling activities is explicit, since incorrect sampling technique can introduce contamination or produce a sample that does not genuinely represent the batch, undermining every subsequent test result based on that sample.
• Sampling equipment itself requires appropriate cleaning and, where relevant, sterilisation controls, recognising that the sampling process itself is a potential contamination introduction point if not properly controlled.

What inspectors look for

• Whether sampling plans have a documented statistical and practical rationale supporting genuine batch representativeness, not just convenience-driven sample locations.
• Whether personnel performing sampling are documented as trained and qualified for this specific activity.
• Whether sampling equipment cleaning and, where applicable, sterilisation practices are adequate to prevent the sampling process itself from introducing contamination.

Related regulations