ISO/TS 22176:2020
(Main)Cosmetics — Analytical methods — Development of a global approach for validation of quantitative analytical methods
Cosmetics — Analytical methods — Development of a global approach for validation of quantitative analytical methods
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.
Cosmétiques — Méthodes analytiques — Développement d’une approche globale pour la validation des méthodes analytiques quantitatives
Le présent document définit une approche globale pour la validation d'une méthode analytique quantitative, fondée sur la construction et l'interprétation d'un profil d'exactitude, et spécifie son mode opératoire de caractérisation. Ce mode opératoire est notamment applicable pour une validation en interne dans un laboratoire d'essais de cosmétiques, mais son domaine d'application peut être élargi à l'interprétation de données recueillies pour une étude interlaboratoires conçue conformément aux recommandations de l'ISO 5725-1. Il ne s'applique pas aux essais microbiologiques. La présente approche est notamment adaptée à la gestion de la large diversité des matrices utilisées dans les cosmétiques. Le présent document ne s'applique qu'aux méthodes déjà mises au point et totalement finalisées pour lesquelles la sélectivité/la spécificité ont déjà été étudiées et pour lesquelles le domaine d'application de la méthode à valider a déjà été défini, en termes de types de matrice et de concentrations de mesurande (par exemple, analyte).
Kozmetika - Analizne metode - Razvoj globalnega pristopa za validacijo kvantitativnih analiznih metod
Ta dokument določa globalni pristop za validacijo kvantitativnih analiznih metod na podlagi priprave in razlage profila točnosti in določa postopek njegove karakterizacije.
Ta postopek predvsem velja za notranjo validacijo kozmetičnega preskuševalnega laboratorija, njegovo področje uporabe pa je mogoče razširiti na razlago podatkov, zbranih za medlaboratorijsko študijo, pripravljeno v skladu s priporočili standarda ISO 5725-1. Ne uporablja se za mikrobiološke raziskave. Ta pristop je predvsem primeren za obravnavo različnih raznolikih matric v kozmetiki. Ta dokument se uporablja samo za povsem razvite in dokončane metode, za katere je bila že preučena selektivnost/specifičnost in je bilo že opredeljeno področje uporabe metode za validacijo v smislu vrst matric in vsebnosti merjenih količin (na primer analita).
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2024
Kozmetika - Analizne metode - Razvoj globalnega pristopa za validacijo
kvantitativnih analiznih metod
Cosmetics - Analytical methods - Development of a global approach for validation of
quantitative analytical methods
Cosmétiques - Méthodes analytiques - Développement d’une approche globale pour la
validation des méthodes analytiques quantitatives
Ta slovenski standard je istoveten z: ISO/TS 22176:2020
ICS:
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
TECHNICAL ISO/TS
SPECIFICATION 22176
First edition
2020-01
Cosmetics — Analytical methods —
Development of a global approach
for validation of quantitative
analytical methods
Cosmétiques — Méthodes analytiques — Développement d’une
approche globale pour la validation des méthodes analytiques
quantitatives
Reference number
©
ISO 2020
© ISO 2020
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ii © ISO 2020 – All rights reserved
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols . 1
3.1 Terms and definitions . 1
3.2 Symbols . 5
4 General principles . 6
4.1 Reminder . 6
4.2 Various conditions for the estimation of precision . 6
4.3 Accuracy profile . 7
5 Procedure. 9
5.1 Definition of the measured quantity . 9
5.2 Definition of objectives . 9
5.2.1 Choice of the scope of validation . 9
5.2.2 Choice of acceptance limits . 9
5.3 Selection of validation samples .10
5.3.1 Choice of the type of matrix or types of matrices .10
5.3.2 Methods for establishing reference values.10
5.4 Characterization plan for validation .10
5.4.1 Organization .10
5.4.2 Choice of the number of series, repetitions and concentrations for the
characterization plan for validation .11
5.5 Calibration plan for the indirect methods .11
5.5.1 Organization .11
5.5.2 Choice of the number of series, repetitions and concentrations for the
calibration plan .12
5.6 Testing .13
5.7 Calculation of predicted inverse concentrations for indirect methods .14
5.7.1 General.14
5.7.2 Calculation of the calibration models .14
5.7.3 Calculation of back-calculated concentrations by inverse prediction .15
5.8 Calculation of the validation criteria by concentration level .15
5.8.1 General.15
5.8.2 Trueness criteria by series .15
5.8.3 Trueness and precision criteria by concentration .16
5.8.4 Calculation of the tolerance intervals .17
5.9 Construction of the accuracy profile .18
5.10 Interpretation of the accuracy profile for validation .19
5.10.1 General.19
5.10.2 Decision rules .20
5.10.3 Definition of the scope of validity .21
5.10.4 Choice of a calibration procedure for the routine .21
5.10.5 Influence and significance of the β proportion .21
5.10.6 Identification of outliers .22
6 Management of the outcomes during routine use .22
Annex A (normative) Calculation of repeatability, intermediate precision and
reproducibility standard deviations.23
Annex B (normative) Contents of the validation file .25
Annex C (informative) Setting-up an assay for determining the accuracy profile in the case
of NDELA in cosmetic samples .27
Annex D (informative) Influence of the value of β on the tolerance interval (R = 3 and s = 1) .37
IP
Annex E (informative) Contribution to the uncertainty calculation .38
Bibliography .39
iv © ISO 2020 – All rights reserved
Foreword
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This document was prepared by Technical Committee ISO/TC 217, Cosmetics.
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Introduction
The purpose of this document is to propose a characterization protocol for the validation of a quantitative
analysis method in the cosmetic field and thus responds to the requirements of ISO/IEC 17025, i.e.
using the performance goals as a basis. The theoretical principles of this approach can be found in
[2]
Reference [1]. This document is based on the French Standard NF V 03-110 .
Analytical methods for analyses of cosmetics need to be validated. Validation has been long considered
as a process consisting in individually verifying several different criteria, i.e. selectivity, repeatability,
[1]
linearity, trueness, etc. The global approach, as proposed since 2003 , is based on the total error
concept and the term ‘’global” means that only a single criterion should be checked to validate a method:
the agreement between a future experimental result and the true value. This approach has already been
[1],[9] [2]
applied in the domains of pharmacy , agricultural chemistry , and is in agreement with quality
assurance guidelines such as GLP or ISO/IEC 17025. This validation process
...
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