GB/T 22275 "Good Laboratory Practice Implementation Requirements" is divided into 7 parts, this part is the third part of GB/T 22275. This part of GB/T 22275 specifies the requirements for laboratory suppliers under the GLP principle, including the following aspects: standards and conformity assessment plans, test systems, animal feed, bedding and water, radioactively labeled chemicals, computer systems, application software, reference materials, instruments, sterile materials, conventional reagents, detergents and disinfectants, and products required for microbiological testing. This part applies to the requirements for laboratory suppliers under the GLP principle. This part has been edited as follows: - The foreword and background of the original text have been deleted; - Note 1 and Note 2 in the original text have been deleted GB/T 22275.3-2008 Requirements for the implementation of good laboratory practice Part 3: Compliance of laboratory suppliers with the principles of good laboratory practice GB/T22275.3-2008 Standard download decompression password: www.bzxz.net
GB/T 22275 "Requirements for the implementation of good laboratory practice" is divided into 7 parts, and this part is Part 3 of GB/T 22275. This part of GB/T 22275 specifies the requirements for laboratory suppliers under the GLP principles, including the following aspects: standards and conformity assessment plans, test systems, animal feed, bedding and water, radioactively labeled chemicals, computer systems, application software, reference materials, instruments, sterile materials, routine reagents, cleaning agents and disinfectants, and products required for microbiological testing. This part applies to the requirements for laboratory suppliers under the GLP principles. This part has been edited as follows: ——Deleted the foreword and background of the original text; -——Deleted Note 1 and Note 2 in the original text
class="f14" style="padding-top:10px; padding-left:12px; padding-bottom:10px;"> GB/T 22275 "Requirements for the Implementation of Good Laboratory Practice" is divided into 7 parts:
---Part 1: Quality Assurance and Good Laboratory Practice;
---Part 2: Tasks and Responsibilities of Project Leaders in Good Laboratory Practice Studies;
---Part 3: Compliance of Laboratory Suppliers with Good Laboratory Practice Principles;
---Part 4: Application of Good Laboratory Practice Principles in Field Studies;
---Part 5: Application of Good Laboratory Practice Principles in Short-term Studies;
---Part 6: Application of good laboratory practice principles in computerized systems;
---Part 7: Application of good laboratory practice principles in the organization and management of multi-site studies.
This part is Part 3 of GB/T 22275.
This part is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) Principles and Conformity Monitoring Series Document No. 5: "Compliance of Laboratory Suppliers with GLP Principles" [ENV/JM/MONO(99)21].
This part has been edited as follows:
---The foreword and background of the original text have been deleted;
---Notes 1 and 2 in the original text have been deleted.
This part was proposed and managed by the National Technical Committee for Standardization of Dangerous Chemicals Management (SAC/TC251).
The drafting unit of this part: Shandong Entry-Exit Inspection and Quarantine Bureau.
The main drafters of this part are Tao Qiang, Wan Min, Yu Xiao, Chen Huiming and Wang Xiaobing.
The clauses in the following documents become clauses of this part through reference in this part of GB/T 22275. For any dated referenced document, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, parties to agreements based on this part are encouraged to study whether the latest versions of these documents can be used. For any undated referenced document, the latest version applies to this part.
GB/T 19001 Quality management system requirements
GB/T 22278-2008 Principles of good laboratory practice
EN 45001-1990 General specifications for laboratory work

ICS 03. 120. 20
National Standard of the People's Republic of China
GB/T22275.3—2008
Requirements of conduct for Good Laboratory Practice(GLP)-Part 3: Compliance of laboratory suppliers with GLP 2008-08-04 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China Standardization Administration of China
2009-04-01 Implementation
GB/T22275 "Implementation Requirements for Good Laboratory Practice" is divided into 7 parts: Part 1: Quality Assurance and Good Laboratory Practice; Part 2: Tasks and Responsibilities of Project Leaders in Good Laboratory Practice Research; Part 3: Compliance of Laboratory Suppliers with Good Laboratory Practice Principles; Part 4: Application of Good Laboratory Practice Principles in Field Research; Part 5: Application of Good Laboratory Practice Principles in Short-term Research; Part 6: Application of Good Laboratory Practice Principles in Computerized Systems; Part 7: Application of Good Laboratory Practice Principles in the Organization and Management of Multi-site Research. This part is Part 3 of GB/T22275. CB/T 22275.3—2008
This part is equivalent to the original Good Laboratory Practice (GLP) and Conformity Monitoring Series Document No. 5 of the Organization for Economic Cooperation and Development (OECD): Compliance of Laboratory Suppliers with GLP Principles [ENV/JM/MONO(99)21]. The following editorial changes have been made to this part: the foreword and background of the original text have been deleted, and Notes 1 and 2 in the original text have been deleted. This part was proposed and coordinated by the National Technical Committee for Standardization of Dangerous Chemicals Management (SAC/TC251). The drafting unit of this part: Shandong Exit-Entry Inspection and Quarantine Bureau. The main drafters of this part: Tao Qiang, Wan Min, Yu Xiao, Chen Huiming, Wang Xiaobing. I
Scope
Requirements for the implementation of good laboratory practice
Part 3: Compliance of laboratory suppliers with the principles of good laboratory practice
GE/T22275.3--2008
This part of GB/T22275 specifies the requirements for laboratory suppliers under the GLP principles, including the following aspects: standards and conformity assessment plans, test systems, animal feed, bedding and water, chemicals with radioactive labels, computer systems, application software, reference materials, instruments, sterile materials, routine reagents, cleaning agents and disinfectants, and products required for microbiological testing. This part applies to the requirements for laboratory suppliers under the GLP principles. 2 Normative references
The provisions of the following documents become the provisions of this part through reference in this part of GB/T22275. For all dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, parties to agreements based on this part are encouraged to study whether the latest versions of these documents can be used. For undated references, the latest edition applies to this standard.
GB/T19001 Quality Management System Requirements
GB/T22278—2008 Principles of Good Laboratory Practice EN45001-1990 General Specifications for Laboratory Work 3 Terms and Definitions
The terms and definitions in GB/T22278—2008 apply to this standard. 4 Requirements
4.1 Standards and Conformity Assessment Schemes
4.1.1 Laboratories use a variety of supplied materials in conducting studies that comply with GLP principles. Suppliers attempt to produce products that meet the obligations set out in the GLP principles for the user. Many suppliers use production methods that comply with national or international standards or are certified in various national qualification systems. This initiative has been anticipated because only in this way can the products they provide be accepted by regulatory authorities that require studies to be conducted in accordance with GLP principles. 4.1.2 It is recommended that suppliers implement GB/T19001. This standard can be supported by EN45001-1990, which stresses the importance of subcontracting in 5.4.7.
4.1.3 Where appropriate, conformity assessment can be particularly useful for suppliers. Conformity assessment systems often monitor members' compliance with national and international standards, so a supplier's or manufacturer's assessment certificate can demonstrate to customers good compliance with standards in addition to other aspects of conformity assessment. Suppliers are advised to strive to obtain membership of a national assessment system where appropriate and feasible. 4.1.4 Although such conformity assessment is an effective supplementary tool to support compliance with GLP principles, it is not an acceptable alternative to GLP compliance, nor can it be internationally recognized as meeting the requirements for data validation set out in the OECD Council Directive. 4.2 Test systems
GB/T 22278-2008 3.8.2.5b) requires that the nature of the test system (animals, plants and other organisms) should be given in the study plan. This requirement can be met directly by information provided by the supplier. In some countries where GLP has been implemented, suppliers who are members of a nationally administered or voluntary conformity assessment system (e.g., for laboratory animals) can provide users with additional written evidence that they are using a test system that meets the quality requirements of GB/T 22275.3-2008. 4.3 Animal feed, bedding and water Although there is no specific requirement in GB/T 22278-2008, animal feed should be analyzed regularly to determine its composition to avoid any potential interference with the test system. Water and bedding should also be analyzed to ensure that contaminants are below levels that may affect test results. Certificates of analysis should be provided by the supplier, including the water management department. The supplier should provide appropriate written evidence to ensure the reliability of the analysis.
4.4 Radiolabeled chemicals
Commercial trade pressures have forced suppliers of radiolabeled chemicals to seek formal compliance with GLP principles by including them in a GLP compliance plan. In most cases suppliers produce labeled test materials that are required to be fully characterized by procedures that follow GLP principles. Suppliers of radiolabeled chemicals may be included in national GLP compliance monitoring programs.
4.5 Computer systems, application software
4.5.1 All computer software, including those obtained from external suppliers, should normally be subject to acceptance testing before being put into use in the laboratory. It can be inferred from this requirement that formal validation of application software completed by the supplier on behalf of the user is acceptable if the user is to adopt formal acceptance testing.
4.5.2 The user should ensure that all software obtained from external sources is provided by approved suppliers. Many suppliers try to meet the user's requirements by implementing GB/T19001. This is considered effective. 4.5.3 GB/T22278-2008 3.1.2.2g) assigns the responsibility for ensuring that the software program is validated to the project manager. This validation can be performed by the user or the supplier, but the process should be fully documented and kept in the archives. If the user performs the validation, there should be a standard operating procedure for validation [see 3.7.4.2b of GB/T22278-2008). 4.5.4 It is the user's responsibility to perform an acceptance test on the software program before using it. This test should be fully documented. 4.6 Reference Materials
4.6.1 The test institution manager is responsible for ensuring that all artificial reference materials meet the requirements of GLP, including the identity, composition, purity and stability of the batch (see 3.6.2.2 and 3.6.2.4 of GB/T22278-2008). 4.6.2 The certificate provided by the supplier should include data on identity, composition, purity and stability (if necessary, stability under specific conditions) and any other characteristics that can appropriately define each batch. In special cases, the supplier may need to provide more information, such as analytical methods, and should be prepared to demonstrate the national or international standards used for quality control, such as reference to "Good Manufacturing Practice" or reference to national or international pharmacopoeias. 4.7 Instruments
4.7.1 It is the responsibility of the test facility manager to ensure that the equipment is fully functional and adequate for its intended use. The test facility manager should also ensure that the equipment is checked and calibrated regularly. Calibrations should be traceable to appropriate national or international standards. If reference standards are maintained by the user, they should be calibrated regularly by a competent authority. 4.7.2 The supplier should provide all necessary information on the proper use of the equipment. For certain categories of equipment, such as balances and standard thermometers, the supplier should also provide a calibration certificate. 4.8 Sterile Materials
It is the responsibility of the test facility manager to ensure that materials that are intended to be sterile have been sterilized by appropriate controlled processes. The supplier should be able to provide appropriate evidence, such as a certificate or reference to a national standard, that materials sterilized by irradiation or other means or reagents are free of contamination by infectious agents or residual disinfectants.
4.9 Conventional Reagents
4.9.1 The user should ensure that reagents are obtained only from suppliers who have been accredited. The supplier should provide any documentation of the status of such accreditation. If there is no national accreditation system, the user should ensure that a certificate of analysis is available from the supplier to prove that the reagents meet the description on the label.
4.9.2 The user is responsible for ensuring, by agreement with the supplier, that all reagents are labeled with sufficient information to meet the specific requirements of GLP2
.
Cleaning agents and disinfectants
GB/T 22275.3—2008
The user should be aware of all active ingredients so that an appropriate choice can be made and any potential contamination or interference that may affect the integrity of the study can be eliminated.
4.11 Products required for microbiological testing
4.11.1 The user is responsible for ensuring, by agreement with the supplier, that all products are labeled with at least the following information: source, identity, date of manufacture, shelf life, storage conditions. 4.11.2 The supplier should ensure that written material is provided to demonstrate any assessment status. If there is no national assessment system, the supplier should provide the user with a confirmation document to demonstrate that the actual situation of the product is consistent with its label description. GB/T22275.3-2008
People's Republic of China
National Standard Promotion
Requirements for the Implementation of Good Laboratory Practice
Part 3: Compliance of Laboratory Suppliers with the Principles of Good Laboratory Practice
GB/T 22275. 3—2008
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