GB/T 38790.1-2020 English PDF (GBT38790.1-2020)

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GB/T 38790.1-2020: Efficacy evaluation of bioactive peptides -- Part 1: General principles
GB/T 38790.1-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 07.080
A 21
Efficacy evaluation of bioactive peptides - Part 1: General
principles
ISSUED ON: APRIL 28, 2020
IMPLEMENTED ON: NOVEMBER 1, 2020
Issued by: State Administration for Market Regulation;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Evaluation content ... 5
5 General principles ... 5
6 Basic requirements ... 5
7 Operation requirements ... 6
Efficacy evaluation of bioactive peptides - Part 1: General
principles
1 Scope
This part of GB/T 38790 specifies the evaluation content, general principles, basic
requirements, and operational requirements of the efficacy evaluation of bioactive
peptides.
This part applies to the laboratory efficacy evaluation of bioactive peptides.
2 Normative references
The following documents are essential to the application of this document. For the dated
referenced documents, only the versions with the indicated dates are applicable to this
document; for the undated referenced documents, only the latest version (including all
the amendments) is applicable to this document.
GB/T 6682 Water for analytical laboratory use - Specification and test methods
GB 14925 Laboratory animal - Requirements of environment and housing facilities
GB 19489 Laboratories - General requirements for biosafety
GB/T 27476.1 Safety in testing laboratories - Part 1: General aspects
GB/T 29252 Rule of the quality inspection of laboratory instruments and
equipment
GB/T 31190 Technical specifications for collecting laboratory chemical waste
GB/T 35507 General rule for biochemical reagents
GB/T 35823 Laboratory animals - General requirements for animal experiment
HG/T 3935 Cell culture media
RB/T 199 Technical code for evaluating biosafety performance of laboratory
equipment
SN/T 1538.1 Guidelines on preparation and production of culture media - Part 1:
General guidelines on quality assurance for the preparation of culture media in the
6.1.3 They shall have received laboratory safety education and master the knowledge
of laboratory biosafety operations.
6.1.4 They shall have the ability to prevent and deal with emergencies in the efficacy
evaluation work.
6.2 Experimental environment
6.2.1 The laboratory environment shall not affect the accuracy of the evaluation results.
6.2.2 The safety of the laboratory for efficacy evaluation shall meet the requirements of
GB 19489 and GB/T 27476.1.
6.2.3 Laboratories adopting zoological efficacy evaluation methods shall meet the
requirements of GB 19489 and GB 14925.
6.3 Experimental equipment
6.3.1 Laboratories shall have the necessary experimental equipment for the efficacy
evaluation of bioactive peptides, and meet the evaluation requirements.
6.3.2 Experimental equipment shall be placed under suitable environmental conditions
to ensure good operating conditions.
6.3.3 The quality of experimental equipment shall meet the requirements of GB/T
29252.
6.3.4 The biosafety performance of experimental equipment shall meet the
requirements of RB/T 199.
6.3.5 A daily maintenance, use, and management system for experimental equipment
shall be established.
7 Operation requirements
7.1 Samples
7.1.1 A special person shall be designated to be responsible for the quality management
and control of samples.
7.1.2 The received samples shall be packaged completely, clearly labeled, and sourced
accurately.
7.1.3 The receiving, storage, sub-packaging, preparation, delivery, and disposal of
samples shall be carried out in accordance with the regulations of SN/T 3509.
7.1.4 A sample sampling plan shall be established, and the sampling volume shall meet
the testing requirements.
7.2 Experimental materials
7.2.1 Laboratory water shall meet the requirements of GB/T 6682.
7.2.2 Biochemical reagents shall meet the requirements of GB/T 35507.
7.2.3 The preparation and management of microbial culture medium, and the
preservation and subculture of bacterial strains shall be carried out in accordance with
the provisions of SN/T 1538.1 and SN/T 2632.
7.2.4 The preparation and management of cell culture medium and cell culture shall be
carried out in accordance with the regulations of HG/T 3935.
7.2.5 The feeding and management of experimental animals shall be carried out in
accordance with the provisions of GB/T 35823.
7.3 Determination method
Efficacy determination shall be carried out in accordance with relevant standards or
validated methods.
7.4 Disposal of waste
7.4.1 After the experiment, the waste shall be disposed of innocuously.
7.4.2 The collection and treatment of waste chemicals shall meet the requirements of
GB/T 31190 and SN/T 3592.
7.4.3 The treatment of microbial waste shall meet the requirements of GB 19489 and
SN/T 4835.
7.4.4 The treatment of experimental animal waste and carcasses shall meet the
requirements of GB 14925.
7.5 Result report
7.5.1 Procedures and management regulations for recording and tracking the evaluation
process shall be established.
7.5.2 Each sample tested shall have a complete test record and report, which shall be
kept on file.
7.5.3 The evaluation report includes complete information such as the sample name,
sample quantity, date of receipt, test items, test methods, test results, test personnel,