|
US$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
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 27425-2020 | English | 249 |
Add to Cart
|
3 days [Need to translate]
|
Good research laboratory practice
| Valid |
GB/T 27425-2020
|
PDF similar to GB/T 27425-2020
Basic data | Standard 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 contents
Preface 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 9
Foreword
This 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.
Introduction
The 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 Laboratories
1 Scope
This 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 references
The 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 definitions
3 Terms and definitions
The 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 responsibilities
4.1 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 plan
5.1 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 Program
6.1 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 environment
7.1 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.
Mobile requirements.
8.1.5 Equipment should be inspected, cleaned and maintained regularly, and equipment files should be established, including installation, modification, failure, maintenance, calibration (verification or inspection), and verification.
Inspection, certification and other records to understand the performance status of the equipment.
8.1.6 When applicable, for dangerous equipment, there should be signs indicating specific dangerous parts and warning items.
8.1.7 The equipment that is decommissioned or no longer in use shall be safely disposed of to avoid hazardous factors such as radiation, chemical, and biological hazards to personnel, the environment or society.
8.2 Materials
8.2.1 Materials used for research should be appropriately marked to ensure correct identification.
8.2.2 Materials that have specified usage characteristics (such as test reagents, etc.) should have labels or other signs, indicating identity information and specified parameters (such as
Concentration, purity, physical and chemical properties, etc.), storage instructions, expiry date, relevant sources, safety information, etc.
8.2.3 The laboratory should have the safety data sheet (MSDS) or basic safety information of the materials used, and it should be available at any time, and the safety data should be updated regularly.
Full data sheet.
8.2.4 All materials should be stored correctly to ensure that they do not affect each other.
8.2.5 Materials should be stored in an orderly, reasonable and safe manner, without affecting work, posing unacceptable risks to personnel, and not hindering emergency evacuation.
8.2.6 A material inventory management system or registration system should be established, and the management of hazardous materials should meet relevant requirements.
8.2.7 Evaluation policies and procedures for materials and qualified suppliers should be established.
8.2.8 A mechanism should be established to ensure that the materials used in each research process meet the requirements.
8.2.9 The acquisition, use, transfer and disposal of all experimental materials shall meet relevant requirements.
8.3 Method
8.3.1 When applicable, research activities shall be carried out in accordance with documented procedures; modifications or deviations of procedures shall be recorded, and those that need to be modified shall be recorded in a timely manner.
The content is documented.
8.3.2 If feasible, the measurement model or input-output model for obtaining the data should be clearly defined and documented procedures should be developed.
8.3.3 All factors that affect the output of research activities should be identified as far as possible, and they should be explained, controlled or evaluated according to needs.
Note. Personnel, equipment, materials, methods, environment, etc. may affect the results of the study.
8.3.4 The output results of all processes should be appropriately traceable or traceable. When applicable and feasible, it should be traced back to the highest available metrology
Level.
8.3.5 If standardized measurement procedures or cited research procedures are used, the application requirements and specified performance shall be evaluated.
8.3.6 The measurement activities of scientific research laboratories refer to standards such as GB/T 27025 and ISO 15189.
8.3.7 When applicable, the process of research activities should be standardized in time.
9 Research records and files
9.1 The content and management requirements of the original records should be clarified, and the research records and archives (including the time limit) should be established, access, inspection, confidentiality, and destruction
The policies and procedures meet the relevant requirements and meet the needs of related parties (such as the client).
9.2 An archive room with access control and storage requirements should be established.
9.3 No one is allowed to tamper with the original record. For the change of the record error, the original record should be identifiable.
date.
9.4 When the paper record method is adopted, a special original record book should be used, the number of pages of the paper should be numbered, and the recipient should register it without damage.
Destroy the original logbook or original record.
9.5 When recording by means of video, sound recording, etc., special equipment should be used and information such as the recording format should be stored. The original recording medium should be properly
save. If it is necessary to save electronic records in the form of export or copy, there should be clear document regulations and authority arrangements.
9.6 The period of archiving the original records and the method, time, location, and use authority of the original records should be specified. According to research
The nature of the project determines whether the researcher can keep records or copies of records for a long time.
9.7 When applicable, the following research materials shall be kept for the specified period.
a) The research plan, research data (including original data), key research materials, quality assurance-related data, and final report of each research
Report etc.;
b) Records of all inspections performed in accordance with the quality assurance plan;
c) Records and repor...
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. The purchased PDF of GB/T 27425-2020_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.
|