Glossary
Retention Sample
A fully packaged unit from a finished product batch, retained so that its labelling and packaging can be checked.
Details
Retention samples are kept as complete packaged units identical to the marketed labelling and packaging of the finished product batch, so that appearance, labelling, packaging, and traceability can be checked. Inspections cite samples that do not represent every pack presentation, insufficient quantity, storage conditions, or retention period, and an inability to produce them promptly when investigating a complaint or a suspected falsified product. Look at the per batch retention register, the completeness of the packaged state, storage conditions and access records, periodic inspection, and disposal approvals.
Related sections
EU GMP Annex 19 §§1–4EU GMP Annex 19 §§7–9
