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GB/T 27406-2008 English PDF

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GB/T 27406-2008: Criterion on quality control of laboratories -- Food toxicology test
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PDF similar to GB/T 27406-2008


Standard similar to GB/T 27406-2008

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Basic data

Standard ID GB/T 27406-2008 (GB/T27406-2008)
Description (Translated English) Criterion on quality control of laboratories -- Food toxicology test
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard A00
Classification of International Standard 03.120.10
Word Count Estimation 33,366
Date of Issue 2008-05-04
Date of Implementation 2008-10-01
Quoted Standard GB/T 1.1; GB 15193.2; GB/T 15483.1; GB/T 19000; GB/T 27025; OECD PRINCIPLES FOR GOOD LABORATORY PRACTICE; VIM common international metrology basic terminology [ measured by the International Bureau, the International Electrotechnical Commission, International Federation of Clinical Chemistry and Experimental Medicine Federation, the International Organization for Standardization
Regulation (derived from) Announcement of Newly Approved National Standards No. 7 of 2008 (No. 120 overall)
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary This standard specifies the quality control of food toxicology testing laboratory management requirements, technical requirements, process control requirements and the results of the quality control requirements. This standard includes food toxicology testing laboratory from accepting applications, sample collection, sample handling and sample test to a survey report, interpretation of the results and make recommendations to the whole process of quality control requirements. This standard applies to food toxicology testing laboratory, is also available for other professional toxicology testing laboratory reference.

GB/T 27406-2008: Criterion on quality control of laboratories -- Food toxicology test

---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.
Criterion on quality control of laboratories. Food toxicology test ICS 03.120.10 A00 National Standards of People's Republic of China Laboratory quality control standards of food toxicology Posted 2008-05-04 2008-10-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Table of Contents

Introduction Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Management Requirements 3 4.1 Organization 3 4.2 Management System 3 4.3 Document control 4 4.4 Quality and Technical Records 4 4.5 5 customer service 4.6 Complaints 5 4.7 Control of nonconforming work 5 4.8 Corrective Action 6 Preventive measures 6 4.9 4.10 Internal Audit 6 4.11 Management Review 6 4.12 Continuous Improvement 7 5 Technical requirements 7 5.1 Procurement Service 7 5.2 7 persons 5.3 Accommodation and environmental conditions 9 Laboratory equipment 10 5.4 5.5 Test System 11 5.6 Traceability 11 6 Process control requirements 11 6.1 General 11 6.2 Test Registration and Contract Review 12 6.3 sample collection, preservation, transport and disposal 12 6.4 Test Program 13 6.5 confirmation test methods and SOP 14 Prepare and Grouping Test System 14 6.6 Pretreatment and reagents 6.7 Preparation of Samples 15 6.8 Test operation 16 6.9 Statistical analysis and results of the evaluation 18 6.10 Subcontracting 18 Report on the results and interpretation 18 6.11 6.12 Supervision and Inspection 19 7 20 Quality Control Results 7.1 Internal Quality Control 20 22 7.2 External Quality Control Appendix A (informative) This standard and GB/T 27025-2008 and OECDGLP terms of table 23 Annex B (informative) Application of the principles of ethics in animal experiments Toxicology 25 Annex C (informative) Laboratory Animal Quarantine 27

Foreword

This standard is one of the series of standard laboratory quality control practices, which currently includes the following criteria. --- GB/T 27401 "Laboratory Quality Control Standards of Animal Quarantine"; --- GB/T 27402 "Laboratory Quality Control Standards for Phytosanitary"; --- GB/T 27403 "food quality control laboratory of molecular biology norms"; --- GB/T 27404 "laboratory quality control practices physical and chemical testing of food"; --- GB/T 27405 "laboratory microbiological testing of food quality control standards"; --- GB/T 27406 "Laboratory quality control standards of food toxicology." Drafting unit is not responsible for identifying any patent rights in this standard may be involved. This standard Annex A, Annex B and Annex C is informative appendix. This standard certification and accreditation by the National Standardization Technical Committee (SAC/TC261) and focal points. The standard by the China National Accreditation Center is responsible for drafting. This standard was drafted. Guangdong Disease Prevention and Control Center, China National Accreditation Center, the State Food and Drug Pipe Authority. The main drafters of this standard. Yang Xingfen, Hao Wei, Luo Jianbo, Lu Jing, and Wu Tong, Song Guilan, Huang Junming, wall Feng Chen, Xi Kun Xiong, He Xiwen, Cai Min, Huhan Yan, He Ping, LIU Li-ping, Huangzhi Biao.

Introduction

This standard mainly in the preparation of GB/T 27025 "testing and calibration laboratories General requirements" as the basis, while absorbing GB/T 19001-2000 "quality management system requirements," the content, and reference documents relevant international professional organizations, domestic and international industry standards Associate and professional literature applicable content, and the full integration of management experience in domestic laboratories. This standard is intended to regulate, guide and help related laboratory, to meet the GB/T 27205 and the professional in the field of quality control of concrete Claim. In addition to GB/T 27205, the standard reference in the art including the main professional document ISO 15189 "Medical Laboratories --- Quality Requirements for capacity and capability ", GB 15193.2" Food toxicology laboratory practice "and the OECD Good Laboratory Practice (Princi- plesofgoodlaboratorypractice, GLP). Furthermore, although this includes the standard applicable to this part of our current areas of expertise as well as part of the safety regulations related content, but this standard Motion does not determine whether the laboratory as to meet the relevant regulations and safety requirements basis. Food toxicology refers to food-related substances evaluated by toxicology testing and methods, food-related materials may include food Product and raw materials, food additives and food containers and packaging materials material substance through food intake may like, which process includes receiving application Please, test the system is ready, save shipping sample collection, sample handling and testing, interpretation and reporting of the results and recommendations, provide advice Wait. This standard applies to food toxicology safety evaluation of areas of expertise, but also as a reference to other similar toxicological testing field work test. In addition, food toxicology testing laboratory capability evaluation, accreditation bodies may also use this standard as a basis for its work. Recommendations related laboratory before using this standard should be familiar with and master the GB/T 27205 relevant content. This standard and GB/T 27025- Terms of 2008 and OECDGLP control see Appendix A. Laboratory quality control standards of food toxicology

1 Scope

This standard specifies requirements for the management of food toxicology testing laboratory quality control, technical requirements, process control requirements and quality control results System requirements. This standard covers food toxicology testing laboratory from accepting the application, sample collection, sample handling and sample testing to issue a test message Advertising, interpret the results and recommendations of the whole process of quality control requirements. This standard applies to food toxicology testing laboratory, also for other professional toxicology testing laboratory reference.

2 Normative references

The following documents contain provisions which, through reference and become the standard terms. For dated reference documents, all subsequent amendments (Not including errata content) or revisions do not apply to this standard, however, encourage the parties to study whether can according to the agreement With the latest versions of these files. For undated reference documents, the latest versions apply to this standard. GB/T 1.1 Standardization Guide Part 1. Standard structure and writing rules (GB/T 1.1-2000, ISO /IEC Directives, Part 3,1997, NEQ) GB 15193.2 food toxicology laboratory practice GB/T 15483.1 ability to use inter-laboratory comparison of verification - Part 1. Development and operation of proficiency testing schemes (GB/T 15483.1-1999, idt ISO /IEC Guide 43-1.1997) GB/T 19000 Quality management systems - Fundamentals and vocabulary (GB/T 19000-2000, idt ISO 9000.2000) GB/T 27025 testing and calibration laboratories General requirements (GB/T 27025-2008, ISO /IEC 17025.2005, IDT) OECDPrinciplesforgoodlaboratorypractice VIM internationally accepted basic metrology terminology [by the Bureau of Weights and Measures (BIPM), the International Electrotechnical Commission (IEC ), International Clinical Chemistry And the Federation of Experimental Medicine (IFCC), the International Organization for Standardization (ISO ), the International Federation of the theory of Pure and Applied Chemistry (IUPAC), International Li Federation of Physics and Applied Physics (IUPAP) and the International Organization of Legal Metrology (OIML) Post]

3 Terms and Definitions

GB/T 1.1, GB/T 15481, GB/T 15483.1, GB/T 19000 and VIM are established and the following terms and definitions apply To this standard. 3.1 Toxicological approach to food-related substance testing and evaluation laboratory, food-related materials may include food and raw materials, Food additive materials and food containers and packaging materials substance through food intake and other possible laboratory test can provide counseling within its scope Consultation services, including interpretation of results and advice. 3.2 Disciplines in toxicology, food safety refers to some kind of food eaten in a predetermined range, food patterns and the consumption conditions, human health It does not produce any damage, that does not cause acute and chronic poisoning, nor As for the contacts and the offspring potential hazards. 3.3 The principle of a phased test during toxicological safety assessment used, and the order in a variety of toxicity tests carried out.

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