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Guideline on validation of test methods for food and cosmetics of import and export - Part 1: General guideline
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Basic data
| Standard ID | SN/T 5326.1-2020 (SN/T5326.1-2020) |
| Description (Translated English) | Guideline on validation of test methods for food and cosmetics of import and export - Part 1: General guideline |
| Sector / Industry | Commodity Inspection Standard (Recommended) |
| Classification of Chinese Standard | X04 |
| Word Count Estimation | 11,194 |
| Date of Issue | 30/12/2020 |
| Date of Implementation | 1/7/2021 |
| Regulation (derived from) | Announcement No. 136 (2020) of the General Administration of Customs |
| Issuing agency(ies) | General Administration of Customs |
SN/T 5326.1-2020: Guideline on validation of test methods for food and cosmetics of import and export - Part 1: General guideline
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/SNT5326.1-2020
Guideline on validation of test methods for food and cosmetics
of import and export
Part 1 : General guideline
Preface
The standard “Validation guidelines of analytical methods for imported and exported food and cosmetics”
consists of the following 6 parts:
——Part 1: General guideline ；
——Part 2: Chemical methods ；
——Part 3: Traditional microbiology methods ；
——Part 4: Molecular biology methods ；
——Part 5: Immunology methods ；
——Part 6: Radioactive analytical methods.
The following is the Part 1.
This part is written according to the rules from GB/T 1.1-2009 “Standardization Guidelines Part 1: the Structure
and Writing Rules of Standards”.
Please note that some of the contents in this part may involve patents. The publisher does not take responsibility
to identify these patents.
This part is proposed and managed by the Department of General Operation, General Administration of Customs,
People’s Republic of China.
This part is drafted by the following institutions: Shenzhen Inspection and Quarantine Research Institute,
Shenzhen Customs, District P.R. China, Shanghai Customs, Nanjing Customs, Tianjin Customs, Fuzhou Customs,
Hangzhou Customs, and Hefei Customs.
This part is mainly drafted by the following people: Zhenfeng Yue, Feng Xiao, Chengui Xiao, Zhenyu Yang, Feng
Xue, Wenjie Zheng, Fang Yang, Qinting Jiang, and Fang Han.
Validation guidelines of analytical methods for imported and
exported food and cosmetics
Part 1: General guideline
1 Scope
This part provides general guidelines for the standard validation of analytical methods for food and cosmetics.
This part applies to the requirements of general validation for establishing standardized analytical methods on
food and cosmetics products, no matter the standard is new, revised, or adopted/modified from international
standards. In addition, when the laboratories use non-standard methods or independently developed new
methods, they can still refer to this part to verify the applicability of these methods.
2 Criteria for references
The following documents are indispensable for the application of this document. For the reference documents
with dates noted, only the dated version applies to this document. For the reference documents without date
noted, the latest edition (including all amendments) applies to this document.
GB/T 27404 Laboratory quality control standard, Physical and chemical testing of food
GB/T 27405 Laboratory quality control standard, Microorganism testing of food
SN/T 0001—2016 The basic rules for the standards of physical and chemical methods on exported food and
cosmetics
SN/T 3266 The standards of test methods and confirmation techniques of food microorganism
3 Terminology and definition
The terms and definitions established in SN/T 0001—2016 and SN/T 3266 applies to this standard. Additionally,
the following terms and definitions also apply to this standard.
3.1 Organization and management agency
This agency is a professional organization, responsible for validating analytical methods, conducting organizing,
reviewing and other management activities. The technology standardization committee for food and the technology
standardization committee for cosmetics (hereinafter referred to as “standardization committee”) is responsible
for managing and reviewing the validation of related analytical methods. The standardization committee carries
out specific responsibilities through the secretariat, including reviewing laboratory qualifications, establishing,
updating, maintaining and validating laboratory databases, appointing and organizing laboratories to carry out
validation, and organizing experts to review the validation documents and analyze validation data.
3.2 In-house validation
The in-house validation is defined as: in the method developing laboratory, within an appropriate time interval,
and under different conditions, the performance of the same method is confirmed by testing and analyzing same
or different test materials.
3.3 Independent laboratory validation
This validation is performed by the labs independent of the method developing party, aiming to test whether the
method performance can be replicated in other laboratories and to meet the expected analyzing purpose.
3.4 Inter-lab validation
This validation is completed by organizing, executing, and evaluating the measurements on same samples from
two or more laboratories under same predetermined conditions, aiming to determine the method performance.
4 The basic principles of analytical method validation
4.1 Validation process
The specific steps of validation are shown in Figure A.1 in Appendix A.
4.2 In-house validation
4.2.1 The method developing laboratory completes the method draft, selects the appropriate validation
parameters (the performance parameters of the method), and designs the in-house validation protocol.
4.2.2 After the method developing laboratory completes the in-house validation according to the selected
parameters and meets the requirements, they can submit the validation materials to the secretariat. Validation
materials should include method drafts, validation protocols, and validation reports.
4.2.3 The secretariat will organize experts to review the integrity and conformity of the validation materials.
4.3 Independent laboratory validation
4.3.1 After the in-house validation materials are approved, the secretariat will organize a laboratory
independent of the method developing party to validate the parameters (the performance parameters of the
method) according to the proposed method.
4.3.2 After the independent validation is completed, the laboratory will submit the validation data to the
secretariat.
4.3.3 The secretariat will organize experts to review the independent validation data and evaluate whether the
collaborative validation should be conducted. Then they will send the results to the method developing party.
4.4 Inter-lab validation
4.4.1 The method developing laboratory is responsible for formulating the inter-lab validation protocol and
submitting the protocol to secretariat for approval.
4.4.2 The secretariat will screen and organize appropriate validation laboratories to participate in inter-lab
validation, and then collect the validation data.
4.4.3 The laboratories participating in inter-lab validation will submit the validation data to the designated
statistical experts for data processing and analysis.
4.4.4 The statistical analysis results will be sent back to the method developing party.
4.5 The applications of validation data
The validation report serves as a scientific basis for the standard review. The secretariat will organize an
expert group to evaluate whether the method can achieve expected goals based on the validation data and
make a conclusion. If the method does not meet the requirements, the conclusion will be notified to the method
developing laboratory, who will then make necessary modifications to the method.
5 Validation protocol
5.1 The method text
The analytical method investigated by validation process should be a standardized method. This method ought
to be robust, that is, small changes in test process will not lead to unpredictable large fluctuations in test results.
In addition, documents of the established method should be clear and complete. All the important operations
involving test environment, including reagents and tools, initial inspection of the equipment, preparation of test
samples, etc., should be recorded in the method text.
The types of food substrate and target compound that apply to the method should be clearly described. The
typical food sample substrates can be found in SN/T 0001-2016 Appendix A.
5.2 The intended applications of the method
The method developing laboratory should describe the intended applications of the method according to real
situations. The description of the intended applications should include the purpose of the method, the type,
existing form, distribution medium and concentration of the analyzing objects, as well as the current regulations
and dynamics, etc.; if necessary, the time domain, region, and industry of the applications should also be
included.
5.3 Validation parameters
5.3.1 The method developing laboratory should select appropriate validation parameters based on the intended
applications and formulate an in-house validation protocol. The typical validation parameters for chemistry test
methods are described in SN/T 0001-2016 and GB/T 27404, and the validation parameters for microbiology test
methods are shown in SN/T 3266 and GB/T 27405.
5.3.2 For the equivalently adopted international standard methods (including the formal methods published
by AOAC), only in-house validation is required; for the modified (equivalent) international standard methods
(including the formal methods published by AOAC), both in-house and independent laboratory validations are
required; for other methods, all three validations, in-house validation, independent laboratory validation, and
collaborative validation, are required.
5.3.3 In-house validation is performed by the method developing laboratory. All the technical parameters of
the method need to be validated.
5.3.4 Independent laboratory validation is completed by the laboratories independent of the method developing
party. The technical parameters that need to be validated are same as the in-house validation.
5.3.5 Inter-lab validation is performed by collaborative laboratories other than the method developing party.
For qualitative methods, at least sensitivity and specificity of the method need to be validated. For quantitative
methods, at least sensitivity, specificity, measurement range, accuracy, and reproducibility need to be validated.
6 The processes of in-house validation
6.1 In-house validation
The method developing laboratory should first complete the in-house validation of all representative sample
substrates specified in the method text, in accordance with the validation protocol, and determine the preliminary
applicability of the method. During the in-house validation process, if the result of a certain parameter indicates
that the method cannot meet the specific requirements, the method must be modified and re-validated until it
can be proved to meet all the test requirements.
6.2 Review of the in-house validation materials
After in-house validation is completed, the validation materials submitted to secretariat should include: method
draft, in-house validation protocol (including operation instructions), and in-house validation report. The
secretariat will organize experts to assess the integrity and conformity of the materials. If the submitted material
is incomplete, the experts committee will require the method developing party to make up for the material; if
the material is complete, the validation protocol is reasonable, and the existing validation results can meet the
requirements, the independent laboratory validation process will be performed.
7 The processes of independent laboratory validation
7.1 Independent laboratory validation
The secretariat organizes a validation laboratory to conduct independent laboratory validation based on the
protocol designed by the method developing party. The validation laboratory will test the validation parameters
(performance parameters of the method) repetitively in order to evaluate whether the method performance can
meet the expected analyzing goals.
7.2 Review of the independent laboratory validation data
The secretariat organizes experts to review the independent laboratory validation data. If the data fails to meet
the expected analyzing goals, experts committee should send the results back to the method developing party and
require them to review the methods and re-conduct the in-house validation; if the results satisfy the expected
analyzing goals, the inter-lab validation should be performed.
8 The processes of inter-lab validation
8.1 Choosing validation laboratories
8.1.1 The number of validation laboratories p: the number of laboratories participating in collaborative
validation is generally 8 to 15. At least 8 valid data reports are required. Only in very rare cases, such as the
number of validation laboratories is insufficient, the test cost is very high, or the samples are difficult to obtain,
etc., fewer laboratories can be used to conduct validation with the agreement from expert committee (no less than
5 valid data reports).
8.1.2 The selected validation laboratories should be representative and well-established. The locations should
also be considered. The selection of validation laboratories should be randomized. It is not allowable to only
select the laboratories with high capability and experience in validation area. The secretariat should randomly
select the collaborative validation laboratories from the validation laboratory database. And the selected labs
conduct collaborative experiments based on the validation protocol. The requirements for validation laboratories
are described in Appendix B.
8.2 The implementation of inter-lab validation
8.2.1 The secretariat contacts the selected validation laboratories. Upon confirmation from the laboratories,
the validation samples (or/and standard solutions/substances) and operation instructions are distributed to
the participating laboratories based on the inter-lab validation protocol. The collaborative experiments are
completed by the laboratories within specified time interval.
8.2.2 The number of tests that each laboratory needs to perform at every test level, n: normally, each laboratory
tests 3 times at every test level. If the possibility of suspicious test results is small, n=2 is generally acceptable.
8.3 Submission of validation data and statistical analysis
8.3.1 According to the requirements of task instructions, the laboratories participating in inter-lab validation
should submit the test data in suggested format (see Appendix C) to the secretariat within the specified
timeframe.
8.3.2 The secretariat forwards the data to designated experts for statistical analysis. After analyzing, the
experts submit the result back to the secretariat.
8.3.3 The secretariat conducts necessary review on the statistical analysis result and send it back to the
method developing laboratory.
9 Simple validation processes for emergency analytical methods
9.1 Scope of application
Applicable to the validation for establishing emergency analytical methods.
...