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Significance and Use
4.1 The demonstration that a method of analysis is fit for its intended purpose and application is done through method characterization and validation.
4.2 Resulting SOPs should be reproducible under the same conditions by a different analyst working in a different laboratory.
4.3 Test methods are designed to assess one or more of the following product attributes: identity, strength or concentration, quality, and purity.
4.4 The steps of this practice contain the basic procedures for performing a TMC, a TMV, and a TMT. It is not imperative that each procedural step be followed in the designated order, but the ordered sequence is a logical progression of the steps for performing a TMC, a TMV, and a TMT.
1.1 The quality, efficacy, and safety of cannabis and products containing cannabis extracts shall be evaluated by validated testing methodologies used by trained staffed utilizing qualified instruments and/or materials.
1.2 This practice provides the cannabis industry with guidance for the development and validation of testing methods that adequately evaluate cannabis and products containing cannabis extracts for quality, efficacy, and consumer health safety in the absence of validated methods from agencies. This includes, but is not limited to, the potency of active substances and adulteration, including impurities stemming from potential adulteration during agricultural or manufacturing processes or both (for example, pesticides, residual solvents, and the presence of fungus and microorganisms) before product approval and release for use. Depending on the methodology and precision and accuracy required, these methods may be both qualitative or quantitative.
1.3 This practice shall define the procedures for test method characterization (TMC), test method validation (TMV), and test method transfer/transfer of analytical procedures (TMT/TAP) of biological, chemical spectroscopic, and physical-based laboratory test methods.
1.4 Depending on the nature of the test in question (chemical, microbiological, etc.) different variables will need to be considered for validation. The particular variables subject to consideration are beyond the scope of this document. Refer to Guide for more guidance.
1.5 This standard does not consider the specifics of acceptable test method limits and users should consult relevant standard literature to determine the appropriate test parameters.
1.6 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Other DocumentsICH Q2(R1) United States 40 CFR Appendix B to Part 136 Definition and Procedure for the Determination of the Method Detection Limit USP 1224 Transfer of Analytical Procedures USP 1225
E2857 Guide for Validating Analytical Methods
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM D8282-19, Standard Practice for Laboratory Test Method Validation and Method Development, ASTM International, West Conshohocken, PA, 2019, www.astm.orgBack to Top