BSI PD ISO/TS 22176:2020

$198.66

Cosmetics. Analytical methods. Development of a global approach for validation of quantitative analytical methods

Published By	Publication Date	Number of Pages
BSI	2020	52

Guaranteed Safe Checkout

Categories: 71.100.70 - Cosmetics. Toiletries, BSI

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

This document defines a global approach for the validation of a quantitative analytical method, based on the construction and interpretation of an accuracy profile, and specifies its characterization procedure.

This procedure is particularly applicable for internal validation in a cosmetic testing laboratory, but its scope can be extended to the interpretation of data collected for an interlaboratory study designed according to the recommendations of the ISO 5725-1. It does not apply to microbiological trials. The present approach is particularly suited to handle the wide diversity of matrices in cosmetics. This document only applies to already fully-developed and finalized methods for which selectivity/specificity have already been studied and the scope of the method to be validated has already been defined, in terms of matrix types and measurand (for example analyte) concentrations.

PDF Catalog

PDF Pages	PDF Title
2	National foreword
7	Foreword
8	Introduction
11	1 Scope 2 Normative references 3 Terms, definitions and symbols 3.1 Terms and definitions
15	3.2 Symbols 4 General principles 4.1 Reminder
16	4.2 Various conditions for the estimation of precision
17	4.3 Accuracy profile
18	5 Procedure 5.1 Definition of the measured quantity
19	5.2 Definition of objectives 5.2.1 Choice of the scope of validation 5.2.2 Choice of acceptance limits 5.3 Selection of validation samples 5.3.1 Choice of the type of matrix or types of matrices 5.3.2 Methods for establishing reference values
20	5.4 Characterization plan for validation 5.4.1 Organization
21	5.4.2 Choice of the number of series, repetitions and concentrations for the characterization plan for validation 5.5 Calibration plan for the indirect methods 5.5.1 Organization
22	5.5.2 Choice of the number of series, repetitions and concentrations for the calibration plan 5.6 Testing
23	5.7 Calculation of predicted inverse concentrations for indirect methods 5.7.1 General
24	5.7.2 Calculation of the calibration models
25	5.7.3 Calculation of back-calculated concentrations by inverse prediction 5.8 Calculation of the validation criteria by concentration level 5.8.1 General 5.8.2 Trueness criteria by series
26	5.8.3 Trueness and precision criteria by concentration 5.8.4 Calculation of the tolerance intervals
28	5.9 Construction of the accuracy profile
29	5.10 Interpretation of the accuracy profile for validation 5.10.1 General 5.10.2 Decision rules
31	5.10.3 Definition of the scope of validity 5.10.4 Choice of a calibration procedure for the routine 5.10.5 Influence and significance of the β proportion
32	5.10.6 Identification of outliers 6 Management of the outcomes during routine use
33	Annex A (normative) Calculation of repeatability, intermediate precision and reproducibility standard deviations
35	Annex B (normative) Contents of the validation file
37	Annex C (informative) Setting-up an assay for determining the accuracy profile in the case of NDELA in cosmetic samples
48	Annex D (informative) Influence of the value of β on the tolerance interval (R = 3 and sIP = 1)
49	Annex E (informative) Contribution to the uncertainty calculation
50	Bibliography