Glossary

Reference Sample

Batch Life of the batch Analysed if needed Retained
Illustration

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.

Source · WHO Quality Assurance of Medicines Terminology Database, Reference sample; PIC/S PE 009-17 Annex 19

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

Related terms

Retention Sample11 casesBatch (or Lot)2,021 casesStability Testing238 cases

Real inspection findings

See 1 findings whose text contains this term

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.

Source

WHO Quality Assurance of Medicines Terminology Database, Reference sample; PIC/S PE 009-17 Annex 19

GRM Regulatory Glossary

243 GMP terms in one place

Each term is explained in plain language with its official source. Look it up here whenever you meet a term you don't know.

Browse the whole glossary
Weekly Newsletter

New GMP inspection findings, every Monday

Every Monday we email the week's new inspection records from the FDA, EMA, Health Canada and MFDS, with a short summary of the week's regulatory news. We'll also let you know when the site gains new features. Unsubscribe any time with one click.

See recent findings first

Sent every Monday · a confirmation email follows when you subscribe · unsubscribe from the footer of any email.