Standard Practice for Laboratory Test Method Validation and Method Development

Importancia y uso:

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.

Subcomité:

D37.03

Referida por:

D8309-21, D8439-22, D8222-21A, D8244-21A, D8244-21A, D8375-23, D8439-22, D8399-23, D8222-21A, D8399-23, D8309-21, D8469-22, D8493-23, D8442-22, D8375-23

Volúmen:

15.10

Número ICS:

11.120.99 (Other standards related to pharmaceutics), 65.020.20 (Plant growing)

Palabras clave:

analytical; cannabis; laboratory; method development; testing; validation;