Methodology Validation Service

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Project Background

The methodology validation service of the Food and Agriculture Division of the Ti Testing and Certification Group can provide customized service solutions for customers' developed methods and for special food registration or record use and so on.

Laws and Regulations Basis

Criterion on Quality Control of Laboratories-Chemical Testing of Food- Annex F (GB/T 27404-2008)

Methods of Food Hygienic Analysis—Physical and Chemical Section—General Principles (GB/T 5009.1-2003)

Requirements of the Chinese Pharmacopoeia

Guidelines for Validation of Drug Quality Standard Analysis Methods

Comformity Assessment—Guidance on Validation and Verification of Chemical Analysical Methods (GB/T 27417-2017)

Requirements for Verification& Validation of Detection Methods and Internal Quality Control on Chemical Analysis (GB/T 32465-2015)

Service Content

1. Methodological studies:comprehensive method validation and project-specific method validation. Parameters include: accuracy, sensitivity, selectivity,precision (repeatabilityand reproducibility), soundness,specificity, detection limit, quantitative limit, linearityrange, durability, uncertainty of measurement ,pre-experiment and other temporary tests. Methodology validation can also be done as specified by the customer.

2. Method optimization: evaluate the possibility of method optimization through expert evaluation, pre-experiment, etc.;

3. Method validation and laboratory management training

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