NCJ Number
218657
Date Published
January 2005
Length
4 pages
Annotation
These guidelines developed by the Scientific Working Group for the Analysis of Seized Drugs address the validation of analytical methods, which refers to the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled by the analytical method used.
Abstract
The report advises that each laboratory should determine whether its current standard operating procedures have been validated, verified, or require further validation and/or verification. The entire validation and/or verification process must be documented, and the documentation must be retained. Documentation must include, but is not limited to, the personnel involved, dates, observations from the process, statement of conclusions and/or recommendations, and authorization-approval signature. In order to meet these requirements, this report presents provisions of a recommended General Validation Plan for methods used in the analysis of seized drugs. This plan should contain an introductory statement that specifies what is being tested, the purpose of the testing, and the results required for acceptance. The body of the plan should state the method to be validated. It is essential that each step in the method be shown to perform satisfactorily. This report outlines the steps that may be included in a method for the identification and/or quantification of seized drugs. The General Validation Plan must also indicate that appropriate reference material is being used for qualitative and quantitative procedures. The plan must also specify performance characteristics. Performance characteristics are listed and explained. The plan should also include an assessment of the contribution of random and systematic errors to the uncertainty of the method's result. Acceptance criteria for quality control parameters should be adopted prior to implementing the method. 3 references