GB/T 33464-2016 English PDF

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GB/T 33464-2016: Guidelines for preparing and using standard operation procedures for chemical analysis
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 33464-2016	279	Add to Cart	3 days	Guidelines for preparing and using standard operation procedures for chemical analysis	Valid

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Basic data

Standard ID: GB/T 33464-2016 (GB/T33464-2016)
Description (Translated English): Guidelines for preparing and using standard operation procedures for chemical analysis
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: A00
Classification of International Standard: 03.120.10
Word Count Estimation: 14,158
Date of Issue: 2016-12-30
Date of Implementation: 2017-07-01
Regulation (derived from): National Standard Notice No.27 of 2016
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

GB/T 33464-2016: Guidelines for preparing and using standard operation procedures for chemical analysis

---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.
Guidelines for preparing and using standard operation procedures for chemical analysis ICS 03.120.10 A00 National Standards of People's Republic of China Guidelines for the preparation and use of standard operating procedures for chemical analysis 2016-12-30 release 2017-07-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Management Committee released

Foreword

This standard is a chemical analysis laboratory testing method validation, validation and internal quality control (InternalQuilityControl, IQC) system One of the series of standards, this series of standards have been or plan to release the following criteria. - Chemical analysis methods Verification and internal quality control terms and definitions; - validation of chemical analysis methods and internal quality control requirements; - internal control of chemical analysis laboratory internal control of the use of control chart analysis system; - Chemical analysis methods Validation and internal quality control implementation guidelines Based on sample digestion of metal component analysis; - Chemical analysis methods Validation and internal quality control implementation guidelines Chromatography and mass spectrometry analysis; - Qualification report on chemical analysis method validation and internal quality control implementation guidelines. This standard is drafted in accordance with the rules given in GB/T 1.1-2009, GB/T 20001.2-2001. This standard by the National Quality Supervision key product testing methods Standardization Technical Committee (SAC/TC374) centralized. The main drafting unit of this standard. Sichuan Province Product Quality Supervision, Inspection and Testing Institute, in the inspection Union (Beijing) Quality Inspection Technology Research Institute Limited (Beijing) Quality Technology Center Co., Ltd., Sichuan Province Food and Drug Inspection and Testing Institute, Guangyuan City Product Quality Supervision and Inspection Institute, Chengdu Hong billion Industrial Group Co., Ltd. drafted. The main drafters of this standard. Zheng Weidong, Wang Ming, Hu Dan, Jiang Weidong, Li Wei, Zheng Haifeng, Zhang Shanyi, Fan Zhigang.

Introduction

Standard operating procedures (StandardOperationProcedure, SOP. The following abbreviations are used) to specify laboratory repeatability A written guidance document for the activity. Scientific preparation and effective implementation of SOP is an integral part of laboratory quality management, its role in To minimize the difference, to ensure that all operations are to comply with the relevant requirements, the laboratory issued a reliable test results and reliable to maintain Consistent; second, the laboratory technology and experience to be inherited, not because of personnel changes affect the quality of testing. This standard is mainly used to guide the chemical analysis laboratory to complete the method to verify or confirm the work, on the basis of the establishment of feasible internal quality After the control system, according to the cited test method standards, combined with technical aspects of the supplement and changes, the preparation of detailed testing procedures and internal quality The amount of control system text, and provide guidance for use. Guidelines for the preparation and use of standard operating procedures for chemical analysis

1 Scope

This standard specifies the chemical analysis laboratory for the use of detection methods, complete the method to confirm the validation and the establishment of internal quality control system After the preparation, review, approval, release, management and use of SOP and other requirements. This standard does not contain general requirements or general requirements for chemical analysis laboratory safety. This standard applies to the Chemical Analysis Laboratory (the term "laboratory" after this standard is the abbreviation of the Chemical Analysis Laboratory) SOP The preparation and use.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. Analytical chemistry terms GB/T 14666-2003 Quality management systems - Fundamentals and terminology GB/T 19000-2008 Conformity assessment vocabulary and general principles GB/T 27000-2006 GB/T 32467-2015 Chemical analysis methods Verification and internal quality control Terms and definitions

3 terms and definitions

GB/T 32467-2015, GB/T 14666-2003, GB/T 19000-2008, GB/T 27000-2006 And the definitions apply to this document.

4 SOP General requirements

4.1 SOP preparation should be included in the laboratory quality assurance program, should be authorized qualified personnel, in accordance with the provisions of the standard format write. The laboratory should ensure that the SOP is detailed, specific, concise, communicates the information accurately and logically, and can be used for testing activities and internal quality Quality control activities provide practical and effective guidance. Note. See Chapter 5 for the contents of the SOP. The format requirements are given in Chapter 6 and Appendix A. 4.2 The laboratory in the method validation or confirmation stage to determine the best test procedures for the laboratory, and in the completion of the method validation or confirmation, With sufficient internal quality control program after the preparation of SOP. Note. Different laboratories use the same method to detect the same sample, and may result in a differentiated result. There are two reasons, one is the actual operation of the differences, performance Local changes to the test conditions, or part of the adjustment of the contents of the program; followed by different laboratories in the internal quality control measures on the differences. 4.3 If necessary, the laboratory shall establish corresponding SOPs for different methods, or for different detection objects of the same method. 4.4 The core content of the SOP shall include the preservation and preparation of the personnel, equipment, reagents, environmental conditions, samples involved in the inspection And other requirements; detailed testing process operation requirements, including the basis of the text of the supplement, quality assurance plan, internal quality control measures, Analysis system verification and so on. The laboratory shall ensure that these contents are scientifically applicable and operational. 4.5 Writers should be familiar with the preparation of the requirements, to master all the technical content of the object, the preparation work should include the draft SOP preparation, comments, Organization discussion, review and other stages. ......

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