Secondary Standard
A working reference standard whose identity and potency have been established by comparison with an official primary standard. Laboratories use secondary standards for routine testing to conserve costly primary material. ICH Q7 accepts them provided they are appropriately tested, documented and requalified at intervals. The certificate should name the primary standard lot used for qualification.
Related terms
EP / Ph. Eur. (European Pharmacopoeia)
The European Pharmacopoeia, published by EDQM of the Council of Europe and legally binding in the states that…
GMP (Good Manufacturing Practice)
Good Manufacturing Practice is the set of quality rules that ensures medicines and their ingredients are cons…
Reference Standard
A highly characterised material used as a benchmark to confirm identity, measure assay or quantify impurities…
USP (United States Pharmacopeia)
The United States Pharmacopeia, published together with the National Formulary by the United States Pharmacop…
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