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

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
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.
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,
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