Glossary
Reference Sample
A sample of a starting material, packaging material, intermediate, or finished product retained so that it can be analysed if needed during the life of the batch.
Details
Reference samples are retained, representative of the batch, so that testing of a starting material, packaging material, or finished product batch can be repeated when required. Inspections cite quantities too small for retesting, and representativeness, identification, storage conditions, retention period, and access control that do not follow the procedure. Check the sampling records, the sample register and labels, storage temperature trends, quantity reconciliation, and issue, testing, and disposal records.
Related sections
EU GMP Annex 19 §§1–4PIC/S PE 009-17 Annex 19
