Glossary
Reference Standard
A substance of established characteristics and purity used as the basis for comparison in analytical testing.
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.
-
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
