DRAFT April 2003 DRAFT GUIDELINES FOR THE VALIDATION OF ANALYTICAL METHODS
Analytical methods used for the verification of the assay and impurity limits must be
validated. Method validation is the process that provides evidence that a given
analytical method, when correctly applied, produces results that are fit for purpose.
These guidelines describe the procedures to be carried out to validate the analytical
procedures included as part of an application for approval of an active constituent and
registration of an agricultural and veterinary chemical product, including those used in
storage stability studies. They are not intended to apply to analytical methods for
residue analysis, biological and biotechnological products.
Analytical methods described in official and recognized publications, such as
Pharmacopoeias [EP, BP, BP (Vet), USP], CIPAC handbooks and AOAC Manual for
a particular active constituent or formulation are regarded as validated and do not
require revalidation. However, the suitability of these methods must be verified under
actual conditions of use i.e., the specificity and precision of the method should be
demonstrated for the published method when applied to the relevant sample matrix
and laboratory conditions.
Analytical methods described in CIPAC handbooks and AOAC manual for an
agricultural active constituent and agricultural chemical product, and in BP, BP (Vet),
EP and USP for veterinary actives and veterinary chemical product are legally
recognised as the regulatory methods, and these procedures (if one is available) are
used by the APVMA for determining compliance with the Agricultural and
Veterinary Chemicals Code Act. It is recommended that ana lytical methods described
in BP, BP (Vet), EP, USP, CIPAC handbooks and AOAC for a particular active
ingredient or formulation be used, where available. Alternative analytical methods
may be proposed by the registrants in place of regulatory methods.
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