GB/T 27425-2020 English PDFUS$249.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 27425-2020: Good research laboratory practice Status: Valid
Basic dataStandard ID: GB/T 27425-2020 (GB/T27425-2020)Description (Translated English): Good research laboratory practice Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A40 Classification of International Standard: 03.100.40 Word Count Estimation: 13,149 Date of Issue: 2020-11-19 Date of Implementation: 2021-06-01 Quoted Standard: GB/T 19000; JJF 1001 Regulation (derived from): National Standard Announcement No. 26 of 2020 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration Summary: This standard specifies good practices for the responsibilities of scientific research laboratory personnel, research plans and plans, quality assurance plans, research facilities and environment, research equipment, research materials and methods, research records and archives, and research reports. This standard applies to the scientific management and sound operation of scientific research laboratories. GB/T 27425-2020: Good research laboratory practice---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.Good research laboratory practice ICS 03.100.40 A40 National Standards of People's Republic of China Good Practice for Research Laboratories 2020-11-19 released 2021-06-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee Table of contentsPreface Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Personnel responsibilities 3 5 Research plan and plan 5 6 Quality Assurance Plan 5 7 Research facilities and environment 5 8 Research equipment, materials and methods 6 9 Research records and archives 7 10 Research report 8 Reference 9ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was proposed and managed by the National Standardization Technical Committee for Certification and Accreditation (SAC/TC261). Drafting organizations of this standard. China National Accreditation Center for Conformity Assessment, National Nanoscience Center, Chinese Academy of Sciences, Ministry of Education Xin, Shanghai Cable Research Institute Co., Ltd., Beijing Zhongshi International Laboratory Proficiency Testing Research Co., Ltd., Jiangsu Subote New Materials Co., Ltd. Co., Ltd. The main drafters of this standard. Song Guilan, Lu Jing, Zeng Yan, Yang Yanlian, Zhang Pengjie, Zhang Xiusong, Shen Mengzhi, Tong Yanchun, Yang Chong.IntroductionThe scientific research laboratory is the basic platform and place for the implementation of scientific and technological innovation. The data issued is the basis for scientific achievements, and its quality directly affects the scientific The reliability and scientificity of the academic results. Judging from the current situation at home and abroad, the management of scientific research laboratories has always been a weakness, and practical management norms documents are urgently needed to guide scientific research laboratories to build a foundation Management system based on scientific methodology. This standard is based on the characteristics of scientific research laboratories, refers to the relevant international management standards, and takes the quality assurance of scientific research data as the core. A set of standardized systems for planning, implementation, inspection, recording, archiving and reporting of research activities. When applying this standard, scientific research laboratories must combine their own characteristics to meet international and national safety and ethical requirements for scientific research laboratories. Be brave to innovate, standardize operations, further refine requirements, and pursue excellence. Good Practice for Research Laboratories1 ScopeThis standard specifies the responsibilities of scientific research laboratory personnel, research plans and plans, quality assurance plans, research facilities and environment, research facilities Good practices for preparation, research materials and methods, research records and files, and research reports. This standard applies to the scientific management and sound operation of scientific research laboratories.2 Normative referencesThe following documents are essential for the application of this document. For dated reference documents, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document. GB/T 19000 Quality Management System Foundation and Terminology JJF1001 General measurement terms and definitions3 Terms and definitionsThe following terms and definitions defined in GB/T 19000 and JJF1001 apply to this document. For ease of use, the following repeated columns Some terms and definitions in JJF1001 are listed. 3.1 Research laboratory A laboratory established and operated for the purpose of scientific and technological research activities. 3.2 Studysite The place where one or more stages of the research process are performed. 3.3 Laboratorymanagement The person who has management authority and is officially responsible for the organization and operation of the laboratory. 3.4 Principal investigator The person responsible for the research project. 3.5 Quality assurance scheme qualityassurancescheme To ensure that the research activities, records, and reports are objective and true. Note. In this standard, hereinafter referred to as QAS. 3.6 Standard operating procedure standardoperatingprocedure Documented and standardized operating procedures and requirements for guiding and standardizing scientific research activities. Note. In this standard, SOP is used hereinafter. 3.7 Studyprotocol Documents detailing research objectives and research design, technical routes, materials, methods, procedures, teams, plans, etc. Note. Including any modifications to these contents. 3.8 Deviation Inconsistent with the prescribed operating procedures, research plans, plans, etc. 3.9 Testsystem Any biological, chemical, physical system or combination used in a research. 3.10 Rawdata Original information observed and recorded in research or laboratory activities. 3.11 Test sample testspecimen Materials collected from the test system for inspection, analysis, or retention. 3.12 Studysample Part or all of the research object. Note. Samples used for research. 3.13 Result comparison resultcomparison Comparison between two or more results. 3.14 Uncertainty of research data uncertaintyofresearchdata Study the dispersion of the data obtained. 3.15 Measurementuncertainty Uncertainty uncertainty According to the information used, it characterizes the non-negative parameters that give the measured value dispersion. [JJF1001-2011, definition 5.18] 3.16 Measuringsystem A set of one or more measuring instruments assembled and suitable for a specific quantity to give measured value information within a specified interval, usually including other Other devices, such as reagents and power supplies. [JJF1001-2011, definition 6.2] 3.17 Measurementmodel The mathematical relationship between all known quantities involved in the measurement. [JJF1001-2011, definition 5.31] 3.18 Intermediatemeasurementprecision The precision of measurement under the condition of precision measurement during a set of periods. [JJF1001-2011, definition 5.12] 3.19 Intermediate precision condition of measurement In addition to the same measurement procedure, the same location, and a set of repeated measurements on the same or similar objects In addition to quantitative conditions, other conditions involving changes can also be included. [JJF1001-2011, definition 5.11] 3.20 Measurementrepeatability Repeatability Measurement precision under a set of repeatable measurement conditions. [[JJF1001-2011, definition 5.13] 3.21 Repeatability condition of measurement The same measurement procedure, the same operator, the same measurement system, the same operating conditions and the same location, and the same or similar A set of measurement conditions similar to the repeated measurement of the measured object. [JJF1001-2011, definition 5.14] 3.22 Measurement reproducibility Measurement precision under reproducible measurement conditions. [JJF1001-2011, definition 5.16] 3.23 Reproducibility condition of measurement Different locations, different operators, different measurement systems, a set of measurement conditions for repeated measurement of the same or similar object under test. [JJF1001-2011, definition 5.15] 3.24 Indoor reproducibility within-laboratory reproducibility Under indoor reproducibility conditions, the precision of reproducibility in this laboratory. 3.25 Indoor reproducibility condition within-laboratory reproducibility condition Different rooms or locations in the same laboratory, different operators, different measurement systems, and different times for the same or similar tested objects A set of measurement conditions for repeated measurements.4 Personnel responsibilities4.1 Responsibilities of laboratory managers 4.1.1 The laboratory manager shall assume management responsibilities through the authorization of the laboratory establishment agency or its designated person. 4.1.2 The responsibilities of the laboratory manager shall at least include. a) Ensure that the operation and research activities of the laboratory meet the relevant requirements; b) Organize the establishment of scientific research integrity and scientific research ethics culture; c) Ensure that the safe working conditions, warning signs and emergency equipment of the laboratory meet the requirements of relevant standards and are suitable for the research undertaken activity; d) Organize the establishment and maintenance of a laboratory management system, and organize the training and assessment of all relevant personnel, and the assessment should not be allowed to fail Qualified or unauthorized personnel to engage in research activities or enter the laboratory; e) Stop behaviors or activities that do not meet management requirements and are unsafe; f) Organize the establishment and maintenance of emergency plans to ensure the normal performance of emergency equipment, and organize all relevant personnel for emergency response regularly drill; g) Ensure that there are clear communication channels with laboratory personnel and all other relevant personnel. 4.2 Responsibilities of the research leader 4.2.1 The research activities carried out by the research leader shall be approved by the laboratory manager. 4.2.2 The research leader shall be responsible for the formulation, implementation and research report of the research plan. The responsibilities of the research leader should include at least. a) Ensure that the research team is familiar with and abides by the laboratory management regulations; when the laboratory management regulations do not apply to the research activities undertaken At the time, it should communicate with the laboratory manager in a timely manner and supplement, modify and improve related systems. b) Ensure that research activities meet international conventions, scientific ethics and relevant requirements of our country; when necessary, actively cooperate with relevant departments and organizations Review and ensure to provide true and objective materials. c) Ensure compliance with scientific research integrity and scientific research ethics culture, and establish a mechanism to avoid inappropriate scientific research behavior due to any pressure. d) Responsible for assessing the risks that may be faced by the research activities, and informing all relevant personnel such as the research team; when necessary, provide them with appropriate And adequate protective equipment, personal protective equipment and protective guidance; do not engage in research activities with uncontrollable risks. e) Clarify occupational health and safety and environmental safety policies, and implement and check the implementation; ensure occupational health and safety and environmental safety performance The efficiency meets the requirements of the management department. f) Establish incident and accident reporting system and reporting procedures. g) When applicable, approve the release of the research protocol and any amendments by signing the name and date or by authorization. h) Ensure that the research team understands the requirements of the research plan and their respective responsibilities, and can obtain relevant documents (including revised documents) in a timely manner. Pieces), guidance. i) Where applicable, appropriate SOPs (including safe operation instructions, etc.) should be formulated to regulate the corresponding activities. j) Ensure that the activities of all research sites are under supervision and are regularly inspected; if necessary, the person in charge of the sub-site or activity can be designated and Clarify its responsibilities and authorities. k) Establish, maintain, and implement research data management procedures, and regularly check the implementation to ensure the quality of data (including various equipment input Data) to ensure objectivity, truthfulness and traceability. l) Establish and maintain QAS and ensure its implementation as planned. m) Enter the research site regularly or irregularly, communicate with the research team, and establish a research log; handle deviations in a timely manner, and modify them when necessary Research plans, procedures, etc. 4.3 Responsibilities of Researchers 4.3.1 Researchers should engage in scientific research activities under the management of the research leader. 4.3.2 The responsibilities of researchers should include at least. a) Do not violate the principles of scientific research integrity and ethics due to any pressure; b) Should master the QAS requirements related to their research; c) Should understand and master safe working methods and protective measures, and comply with laboratory management requirements and research plans; d) When necessary, report health or physical examination status as required; e) The plan and procedures that deviate or need to be modified should be communicated with the research leader in a timely manner and recorded objectively; f) Raw data should be recorded and collected in a timely and accurate manner, and responsible for the quality of the data; g) Actively observe, identify and report new problems and abnormal phenomena in research activities and make objective records; research work should be established Log; h) Safety hazards, incidents or accidents should be reported in time.5 Research plan and plan5.1 Each research should form a documented research plan, including (but not limited to) research purpose, design, technical route, materials, and methods when applicable. Laws, procedures, teams, plans, etc. 5.2 To evaluate the scientific research content of the research plan, the safety, ethics, and legality involved in the research activities should also be evaluated. And to ensure compliance with relevant requirements. 5.3 Modifications and deviations of the research plan shall be recorded. 5.4 When applicable, the research plan should be reviewed by relevant safety, ethics, animal welfare, and confidentiality committees.6 Quality Assurance Program6.1 According to the characteristics of research activities, a documented QAS should be formulated in accordance with the principles of this document. 6.2 QAS shall aim at ensuring the objectivity, truthfulness, traceability and accuracy of research data. 6.3 The quality of research data collection, data conversion, data analysis, data reporting, data security, data archiving, data storage, etc. should be established. Control measures and implement monitoring. 6.4 When feasible, quantifiable, verifiable, and evaluable quality indicators should be set based on the input and output of the process. 6.5 A project management mechanism should be established. The research leader or its designated personnel should regularly check the research process and the quality of the research data, and evaluate The suitability of the quality assurance program, and timely remedial measures when necessary. 6.6 Common quality assurance techniques include (not limited to). a) Compare with constant; b) Compare with reference standards or reference objects; c) Compare with recognized methods; d) Indoor reproducibility evaluation; e) Comparison or proficiency test; f) Cooperative test; g) Recovery test; h) Compare with mathematical models or empirical models; i) Comparison of different experimental schemes; j) Compare with information in recognized databases; k) Uncertainty assessment; l) Non-standard method confirmation. 6.7 All important factors affecting the results shall be identified, controlled and recorded. 6.8 An internal evaluation mechanism should be established, and an academic committee is recommended. 6.9 When applicable, an external evaluation mechanism should be established. 6.10 When applicable, a quality assurance plan suitable for research in subcontracting, cooperative and other methods should be formulated.7 Research facilities and environment7.1 Research facilities include environmental control systems, test activity sites, research material storage, research instrument rooms, auxiliary workshops, and test departments System facilities (such as animal rooms, etc.), preparation rooms, isolation rooms, archives, etc., functional areas and work flow arrangements should meet the research activities engaged in. 7.2 The safety of research facilities or sites, including the safety of the surrounding environment and communities, should meet relevant requirements. 7.3 The research facility or site should have an appropriate area and structure to meet the research needs, and reduce the interference factors that affect the effectiveness of the research to lowest. 7.4 If a research facility or site involves multiple research, incompatible items or activities, its design should provide appropriate separation to ensure that each The study can be carried out under the prescribed conditions, and incompatible items or activities do not interfere with each other. 7.5 When necessary, the environmental parameters of the research facility or site should be able to be controlled, monitored and recorded, and meet the scope and control of the research project's change. The requirements of system accuracy. 7.6 The storage place for research materials should be able to maintain the characteristics, concentration, purity and stability of the materials, and ensure that they meet the safety requirements for storing dangerous goods. Seek peace and security requirements. 7.7 When necessary, separate retention and sample storage rooms for research objects or test samples should be set up separately, and storage conditions should meet the requirements of research activities. Requirements, safety requirements and security requirements. 7.8 When necessary, the archives room should ensure safe access to important information such as research documents and original data, and ensure that the storage conditions can prevent it from passing. Damaged early. 7.9 When necessary, appropriate waste collection, storage and treatment facilities should be provided, including consideration of waste detoxification and transportation mechanisms. 8 Research equipment, materials and methods 8.1 Equipment 8.1.1 Equipment (including computing systems) used for research and control and research related environmental factors should be reasonably and properly placed, and the performance should meet need. 8.1.2 When applicable, all equipment should be regularly calibrated (internal calibration can be carried out), verification or verification, and the period should be set to ensure the Performance meets the requirements as the principle. Internal calibration should be carried out by trained personnel in accordance with prescribed procedures. Wherever feasible, it should be traceable to the existing The highest metrology level. 8.1.3 The equipment should be checked before use to ensure that its nominal performance meets the requirements of research activities. 8.1.4 For equipment that does not have the conditions for calibration, verification or inspection, a feasible mechanism shall be established to prove that its nominal performance is in line with research activities. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 27425-2020_English be delivered?Answer: Upon your order, we will start to translate GB/T 27425-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 27425-2020_English with my colleagues?Answer: Yes. 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