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Significance and Use
3.1 Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. There are numerous documents that address the topic of validation but there are few validation protocols for methods specific to seized drug analysis. This practice makes recommendations for the validation of both qualitative and quantitative methods used for the analysis of seized drugs.
1.1 This practice addresses the validation of qualitative and quantitative seized-drug analytical methods. It discusses the validation of analytical methods in terms of their part in analytical schemes and in terms of performance characteristics including brief mention of measurement uncertainty and quality control parameters.
1.2 This practice does not replace knowledge, skill, ability, experience, education or training and should be used in conjunction with professional judgment.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E2327 Practice for Quality Assurance of Laboratories Performing Seized-Drug Analysis
E2764 Practice for Uncertainty Assessment in the Context of Seized-Drug Analysis
ICS Number Code 11.100.01 (Laboratory medicine in general)
ASTM E2549-14, Standard Practice for Validation of Seized-Drug Analytical Methods, ASTM International, West Conshohocken, PA, 2014, www.astm.orgBack to Top