GB/T 38790.1-2020Efficacy evaluation of bioactive peptides—Part 1:General principles (English PDF)

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.

7.1 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, […]