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GB 15193.2-2014 English PDF

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GB 15193.2-2014: National Food Safety Standard -- Good laboratory practice for food toxicology
Status: Valid

GB 15193.2: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
GB 15193.2-2014209 Add to Cart 3 days National Food Safety Standard -- Good laboratory practice for food toxicology Valid
GB 15193.2-2003319 Add to Cart 3 days Good laboratory practice for food toxicology Obsolete
GB 15193.2-1994239 Add to Cart 2 days Good laboratory practice for food toxicology Obsolete

Similar standards

GB 15193.29   GB 15193.28   GB 15193.1   GB 15193.13   GB 15193.11   GB 15193.4   

Basic data

Standard ID: GB 15193.2-2014 (GB15193.2-2014)
Description (Translated English): National Food Safety Standard -- Good laboratory practice for food toxicology
Sector / Industry: National Standard
Classification of Chinese Standard: C53
Classification of International Standard: 07.100
Word Count Estimation: 9,931
Date of Issue: 12/24/2014
Date of Implementation: 5/1/2015
Older Standard (superseded by this standard): GB 15193.2-2003
Regulation (derived from): Health Planning Commission Bulletin 2014 No. 21
Issuing agency(ies): National Health and Family Planning Commission of the People's Republic of China
Summary: This Standard specifies requirements for food toxicology laboratory. This Standard is applicable to food toxicology tests conducted laboratory.

GB 15193.2-2014: National Food Safety Standard -- Good laboratory practice for food toxicology

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
National Food Safety Standard.Good laboratory practice for food toxicology National Standards of People's Republic of China National Food Safety Standard Food toxicology laboratory practice Issued on.2014-12-24 2015-05-01 implementation People's Republic of China National Health and Family Planning Commission released

Foreword

This standard replaces GB 15193.2-2003 "food toxicology laboratory practice." This standard compared with GB 15193.2-2003, the main changes are as follows. --- Standard name was changed to "national food safety standards of food toxicology laboratory practice"; --- Modify the scope; --- Modify the terms and definitions; --- Modify the personnel and organization; --- Modify the laboratory; --- Modify the design and implementation of the inspection; --- Modify the records and information; --- Modify the test report; --- Modify the environment; --- Modified experimental animals and animal room contents; --- Increased quality assurance testing process; --- Increased test preparation; --- Increased test examples; --- Increased reporting and interpretation; --- Increased data retention requirements specimens. National Food Safety Standard Food toxicology laboratory practice

1 Scope

This standard specifies the requirements for food toxicology laboratory operations. This standard applies to food toxicology tests conducted laboratory.

2 Terms and definitions

2.1 laboratory director Overall responsibility for the laboratory work, ensure that the test according to laboratory practices requirements for the operation of the people. 2.2 Project Leader Overall responsibility to carry out some kind of test substance toxicology test job. 2.3 Quality assurance personnel Familiar with the inspection of a specific person, they do not participate in supervised trials by monitoring the testing process to ensure lab work breaks Together the relevant specifications. 2.4 Standard Operating Procedures Details of the implementation of routine testing operations. 2.5 Test Plan Clearly defined written materials testing purposes and experimental design, and other related information. 2.6 sourcebook Experimental study observed during the recording of the test activities, including all test records and data, automatically record test analysis on the instrument Data, photos, and audio and video recording, the original or a copy of a computer-readable media. 2.7 Test System System for testing the toxicity of the test substance, such as laboratory animals, microorganisms, cells and subcellular components and other biological, chemical, physical system. 2.8 Samples Inspection by the commission or by a third party to extract a representative sample. 2.9 test substance Single ingredient or mixture being tested. 2.10 controls In the study, the test was used as a comparison substance. 2.11 specimens Obtained from one or more of the test system used to test, analysis, or stored material. 2.12 dose The dose of the test substance in the test Test System. 2.13 Batch In one particular production process produced a number of test substance or controls, their properties should be identical. 2.14 Test Start Date Start a record of the date of the original data. 2.15 Test End Date Record the last date of the original data. 2.16 Project Start Date Date of the laboratory director or authorized signatory signed research program. 2.17 Project end date Date of the laboratory director or authorized signatory to sign the final report. 2.18 Animal Welfare Let the animals in a healthy and happy state of existence, the standard includes no animal diseases, no abnormal behavior, no psychological stress, depression and pain Waiting.

3 organization and personnel

3.1 The laboratory should obtain appropriate qualifications (measurement certification/Laboratory Accreditation), it should be equipped with the laboratory director, the project leader, the corresponding test Personnel and support staff. 3.2 laboratory director's responsibilities are. --- Ensure adequate qualified personnel to perform their duties in accordance with regulations; --- Before the start of each project, identified by the project leader; --- To ensure that all facilities, equipment and test conditions are met; --- Organizations to develop and modify the standard operating procedures to ensure that testing personnel acquire the relevant standard operating procedures; --- Organizational plan table, examination and approval of test plans and test reports, to grasp the progress of the trial; --- Establishment of animal ethics committee. 3.3 Project Leader for the whole process is responsible for undertaking the project, and should be subject to the laboratory director of guidance, at least the project leader responsibilities also include. --- Proposed test plan and organize the testing personnel to test; to ensure accordance with the test plan and the corresponding standard operating procedures (Standardoperatingprocedures, SOPs) test, any deviation from the test plan should have procedures is confirmed, Changes in the content and reasons for the change should be recorded and filed; --- Make sure that all information is complete original, a true record; the effectiveness of the testing process and test data meet the requirements of this standard is responsible. 3.4 Test personnel should receive the guidance of the project leader, in strict accordance with the test plan and SOPs to operate. Should participate in different positions relative Continuing education program and should receive specialized training in quality management. Animal testing operator, read the piece (genetic toxicology and pathology toxicity Science, etc.) personnel should be given special technical training and the need to obtain the appropriate qualification or authorization. 3.5 The laboratory shall authorize someone to perform specific tasks, such as animal breeding, quarantine, anatomy, drawing, specific types of equipment operation, experimental Operating room information systems and the like, as necessary, to obtain the corresponding qualifications (such as an animal keeper and pressure vessel operators, etc.). 3.6 Animal experiments related personnel should be regularly (once a year) medical examination, with laboratory animals hinder the work of the staff shall not engage in disease Experimental animals.

4 Quality assurance testing process

4.1 The laboratory shall have a quality assurance personnel. Quality assurance personnel appointed directly by the responsible person directly responsible for the organization, and are familiar with Experimental procedure. 4.2 Quality assurance personnel are not involved in the trial work to oversee the project. 4.3 Quality assurance personnel should monitor environmental facilities, equipment and reference material meets the test requirements, whether the project in strict accordance with test test Plan, test operation is standard, whether carried out in strict accordance with existing SOPs, test data and results of the evaluation are correct and so on. 4.4 Quality assurance checks should implement faithfully save inspection records and sign the archive. Problems found during the checks shall promptly notify the project negative Responsibility and head of the laboratory, the right to suspend the test if necessary.

5 Test preparation

Receiving, preservation and transport of samples 5.1 5.1.1 The samples were unique identification. 5.1.2 the establishment of service safekeeping sample, the sample out of storage time, the number of reception, storage method, the amount of the test, the remaining amount of the sample is recorded and signature. 5.1.3 understand the characteristics of the sample, such as batch number, purity, composition, concentration, stability, solubility, content preservation conditions and test conditions. Determine the appropriate preservation and transport methods based on the physical, chemical and biological properties, processing and packaging of samples and other information, and will have Related information service personnel. 5.2 test methods and standard operating procedures 5.2.1 The test method shall be carried out with reference to GB 15193.1, may also be used, if necessary, non-standard methods, but subject to certain procedures, to determine, Verification and confirm the effectiveness of non-standard methods. 5.2.2 The laboratory shall have a trial-related SOPs, and by the head of the laboratory for examination and approval. According to the test needs to be updated SOPs. Test personnel should be able to timely and convenient access to the required current effective SOPs. 5.2.3 Inspection work in deviation from standard operating procedures should be documented and assess the impact of deviations from the test results, make test termination Or continue to experience overall judgment tests. 5.2.4 SOPs should include at least the following. a) the test substance. receipt, identification, marking, handling, sampling and storage; b) Equipment. Use, maintenance, cleaning and calibration; c) Materials, reagents and solutions. preparation and marking; d) computer systems. validation, operation, maintenance, security, change control and backup; Save e) recording, reporting, storage. item number, data collection, preparation of reports, indexing systems, data processing, including computer Use of the system; f) Test Systems. Test System (experimental animals, cell lines, etc.) to receive, transfer, proper placement, characterization, identification and management of program; Prepare g) test system of observation and inspection; Experimental h) of individual animals dying during the experimental treatment or time of death; i) specimen collection, validation and processing; j) waste disposal; k) quality assurance procedures. planning, scheduling, execution, documentation and quality assurance inspection report operating personnel. 5.3 Test equipment, reagents, consumables and laboratory animals 5.3.1 The laboratory should be equipped with the necessary equipment to meet the test. Equipment should be able to reach a clear and meet the conditions required by the relevant inspection. 5.3.2 The laboratory shall establish procedures for periodic testing, maintenance and calibration of equipment. 5.3.3 trained and authorized personnel may operate the equipment. 5.3.4 Laboratory personnel should purchase of reagents, supplies verification, inspection, quality should meet the required test requirements within its validity In the use, storage conditions to meet the requirements. 5.3.5 Experimental animals should have production licenses ordered from experimental animals, laboratory animals and accompanied by a certificate of quality. 5.4 Facilities and Environment 5.4.1 facilities and the environment should be consistent with GB 50447, GB 19489 and ISO 15190 and related regulations. 5.4.2 The laboratory shall be designed in accordance with the purposes and layout to function effectively. If the adjacent test area to carry out mutual influence test shall We shall make the necessary separation. Measures should be taken to prevent cross-contamination. Special work area should be clearly identified and effective control, monitoring and recording. 5.4.3 Laboratory test facilities should be conducive to effectively carry out inspection work. These include at least energy, lighting, water supply, ventilation, Pressure, temperature and humidity regulation, waste disposal and disinfection. 5.4.4 should provide the appropriate storage space and conditions for the sample, strain, cell lines, tissue blocks, sections, documentation, manuals, equipment, reagents, Storage and safekeeping of records and test results, etc., and have someone to manage. 5.4.5 When the environmental factors that may affect the test results, the laboratory shall monitor, control and record environmental conditions. Special attention should be cleanliness, temperature Humidity, animal room air ammonia concentration, cell count falls, pressure gradient, noise, radiation (if necessary) and other changes in circumstances. 5.4.6 Laboratory Animal breeding environment and conditions should be consistent with GB 5749, GB 14922.1, GB 14922.2, GB 14924.1, GB 14924.2, GB 14925 and related regulations. 5.4.6.1 should control personnel enter or use the region will affect the quality of the examinations. Shall take appropriate measures to protect the test substance and facilities, environmental Security, preventing contact with unrelated persons. 5.4.6.2 animal breeding facilities should meet the requirements of food toxicology tests carried out, to the corresponding national standards and departmental regulations and agreed Take the appropriate level of animal license. Animal feed, litter, cages, water sanitation, etc. shall meet the appropriate level of animal room management Requirements. 5.4.6.3 separated feeder according to animal species, strain, source, or pilot projects, and to isolate sick animals. 5.4.6.4 having a known hazard test substance (including volatile components, radioactive substances, biological hazards and having "three letter" hazardous substance Quality), must be in a separate room or area in particular animal testing, to prevent environmental pollution. 5.4.6.5 should have an independent laboratory animal quarantine area, with animal welfare and animal waste collection facilities. Test Example 6 6.1 Test Plan 6.1.1 The test plan should be developed before the test, and be saved as raw data. 6.1.2 The test plan shall at least include. a) Name of the sample and the acceptance number; b) test names and test purposes; c) the principal name and address; d) Laboratory name and address; e) project leader, list of testing personnel and division of labor; f) animal ethics review, including the development of an animal during the operation to minimize discomfort after the dying animal and test the implementation of peace Death and other programs; g) the timing of the test; h) pre-treatment of samples and controls; i) determining the test method; j) the environmental conditions of the test; k) selection and grouping method test system; l) Pre-testing of embodiments (if necessary); Method m) Specific administration of the test substance, such as dose, route, frequency, duration, etc; n) specimen collection and index tests, including hematology, biochemistry and pathology, etc; o) content of test records, statistical analysis of test data; p) during the test abnormal situation should take measures plan; Sound processing q) during the test and after the end of Hazardous Substances (as positive control) and experimental animals and cell tissues such as Program. 6.1.3 Test Plan prepared by the project leader, after the signing of approval by the person in charge of the implementation of the laboratory. 6.1.4 should ensure that before the start of the test, a test of each person involved in the pilot project are aware of the content of the pilot scheme. 6.1.5 test problems found during the pilot scheme should be based on the specific circumstances, decide whether to suspend or terminate the test, if necessary, repair Change test plans, test plans revised by the laboratory responsible for re-approval. 6.2 Test system preparation and grouping 6.2.1 Test System Preparation. a) Select the test system shall be in accordance with the requirements of the pilot project, to meet the needs of the pilot project testing. b) shall ensure that the test system Origin clear, clear lines, known biological characteristics; animal health should be recognized only after quarantine experimenting. Source c) test system, germline cell passage number, arrival time, and the growth and health status should be documented. d) the import, purchase, acquisition, use and disposal of these test systems should comply with relevant national regulations and standards. 6.2.2 Test System Group. a) should be required to set up a pilot scheme of each dose group and the necessary controls, etc; b) Test System Packet should follow the requirements of statistics, the number of each group of test systems should be able to meet the test methods and results of statistical skills Operation requirements; c) experimental animals should be identified by appropriate means, to ensure the identification trial period legible; d) test systems grouped cages or culture on the container label should indicate the project name, strain, sex, group, group dates, Trial start date, the project leader and other necessary information. 6.3 test substance pretreatment and reagent preparation Processing Method 6.3.1 test substance should not destroy or alter its chemical structure, composition and biological activity. 6.3.2 test substance, mixture controls vehicle shall comply with the test requirements. Solvent mixture should be used in the test or control substance Laid Resistance, test systems, program implementation and test results did not interfere. 6.3.3 stability test substance should be considered in a solvent, and if necessary take appropriate measures to minimize its effects, as it susceptible to oxidation Or decomposition, should be freshly prepared before use. 6.3.4 ensure that the test should be uniformly dispersed in a solvent. Some of the solvent-insoluble powdery substance, may be formulated into a suspension in a given sample Mix well before the operation. 6.3.5 After the test was processed timely identification, including at least the following information. the name of the test substance, the pilot project, the test substance concentration, vehicle name He said that the preparation or processing date, expiry date, preservation method to prepare people. 6.3.6 Reagent preparation should be aware of the following requirements. a) reagent weighing, dilution or concentration, constant volume and adjust pH and other operations should be strictly in accordance with SOPs; b) with the reagent solution should be kept properly to avoid contamination and deterioration when weighed and use; c) agents are clearly identified, including at least name, concentration, preparation date, expiration date, retention requirements and preparation people. 6.4 Test operation 6.4.1 test substance to like manner. a) shall be given in accordance with the test plan and test systems test substance controls to ensure that the amount given is accurate, consistent manner to the sample; b) For the cultured cells or bacteria, should be strictly aseptic technique to avoid contamination, should ensure that a given test substance and controls even distribution Growth in the culture and the environment; c) Test System test found during unforeseen circumstances, such as non-animal test substance factors to disease, death or cultured cells Contamination, etc., should be immediately reported to the project leader, to take timely remedial measures, and make safety testing personnel and the environment jobs; d) According to the test substance in experimental animals palatability, select the appropriate mode of administration of the test substance (incorporated in feed, orally or drinking water). 6.4.2 Test observation. a) during the test requirements of the pilot program should test system was observed; b) gross observation of experimental animals, including appearance, behavior, signs of poisoning and death and so on; c) an observation......
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