Glossary
Reference Standard
A substance of established characteristics and purity used as the basis for comparison in analytical testing.
Source · WHO Quality Assurance of Medicines Terminology Database, Reference substance (or standard)
Related sections
21 CFR 211.160–211.194EU GMP Part I Chapter 6
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Concerning the Sarracenia Purpurea 0.17 g/mL for injection drug product, you have neither identified nor provided evidence of the active pharmaceutical ingredient’s strength by a method that is highly specific and uses a reference standard.
FDA · FDA Warning Letter · 2023-08-08 -
Specifically, system suitability and reference standard (a) injections were not included in the sequences for multiple batch analyses.
EMA · EU GMP NCR (EudraGMDP) · 2026-07-03 -
Laboratory records do not include complete records of any testing and standardization of laboratory reference standards.
FDA · FDA 483 · 2019-08-08
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 substance (or standard)GRM Regulatory Glossary
243 GMP terms in one place
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