Advisory document for good laboratory practice : Establishment and control of archives that operate in compliance with the principles of GLP
Some standard content:
ICS 03. 120. 20
National Standard of the People's Republic of China
GB/T22272—2008
Advisory document for Good Laboratory Practice: Establishment and control of archives that operate incompliance with the principles of GLP2008-08-04 Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
Standardization Administration of the People's Republic of China
2009-04-01 Implementation
GB/T22272--2008
This standard adopts the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and compliance monitoring series document No. 15: "Establishing and managing files in accordance with GLP principles" [OECDENV/JM/MONO(2007)10, English version]. The following editorial changes have been made to this standard:
- The background introduction and introduction of OFCD in the original text have been deleted. This standard was proposed and managed by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251). The drafting units of this standard are: China Institute of Inspection and Quarantine, China Petroleum and Chemical Industry Association. Drafters of this standard: Chen Huiming, Yu Wenlian, Wang Xiaobing, Mei Jian, Sun Xin. 1 Preface
Constructive Documents of Good Laboratory Practice
Establish and manage archives that comply with the principles of good laboratory practice
GB/T 22272--2008
Archiving of materials and records generated in non-clinical health and environmental safety studies is an important part of complying with the original plan of good laboratory practice. Preserving the original data related to a specific study and the samples generated in the study is the only way to reproduce the research process, verify the information in the final report, and prove that the study complies with the requirements of GLP. This standard is intended to help test institutions to make their archive management comply with the requirements of good laboratory practice principles. This standard does not replace relevant requirements in national regulations and/or laws, such as the requirements for archive retention period. 2 Scope
This standard is applicable to test institutions, contracted archives, contracted quality assurance or information technology (IT) service organizations and clients that follow the principles of GLP, as well as GLP compliance supervision departments and receiving departments. Organizations involved in the trial should ensure that applicable regulatory requirements are evaluated against their business needs. Certain aspects of archive construction and operation may be related to regulations or laws that establish public health and safety, and these aspects are not within the scope of this standard. Testing institutions and other organizations that implement GLP archive management for records and materials can benefit from using recognized archive management standards, including those related metadata.
3 Normative references
The clauses in the following documents become clauses of this standard through reference in this standard. For dated referenced documents, all subsequent amendments (excluding errata) or revisions are not applicable to this standard, however, parties to agreements based on this standard are encouraged to investigate whether the latest versions of these documents can be used. For undated referenced documents, the latest versions apply to this standard. GB/T22278--2008 Principles of Good Laboratory Practice 4 Terms and Definitions
The following terms and definitions apply to this standard. 4.1
Archive
A designated area or facility (e.g., filing cabinet, room, building, or electronic system) used for the secure storage and preservation of records and materials. 4.2
Archive staff
A person who works under the supervision of an archivist and is responsible for the day-to-day management of archives. 4.3
Archiver
A person assigned by the test facility manager or test site manager to be responsible for archive management, such as archiving operations and procedures. 4.4
electronic archives
Electronic archives
Electronic records maintained by test facilities and systems in accordance with the requirements of G1.P principles. 1
GB/T 22272—2008
Electronic recordselecronic recurd
All original laboratory records and documents, including data directly input into the computer through the instrument interface, original observations and activities in the study, and original records necessary for the reproduction and evaluation of the research report. 4.6
Metadatametadata
Data describing other data attributes, which usually describe the structure, data elements, relationships and characteristics of the electronic record. 4.7
Migration
The conversion of electronic records from one format, medium or electronic system to another format, or the transfer to another medium or electronic system. 4.8
System administratorsystemowner
The manager of the department that has the greatest impact on the system, or the designated person, or the main user of the system. 5 Roles and Responsibilities
5.1 The Client
The client plays an active role in the conduct of all nonclinical health and environmental safety studies in accordance with GLP principles. The client should ensure that materials and records supporting regulatory studies are maintained under conditions that ensure their integrity and continuity. If records and materials are transferred to the client, they should be archived and meet the requirements of GLP principles. The client should retain study materials and records for the time periods required by the relevant departments. Archives and retained materials and records should be available for review during business hours. Electronic records should be maintained in a readable format.
5.2 Site Manager
5.2.1 The site manager is responsible for providing archival facilities. The site manager should appoint a dedicated person as the archival manager and, if necessary, additional archival staff to perform archiving work. When the archival manager is unable to perform his or her duties, the site manager should delegate to others to perform his or her duties. These delegations should be documented. When the original designated archive manager and the designated archive manager exist at the same time, the test institution manager should distinguish the responsibilities to avoid conflicts. 5.2.2 The test institution manager should ensure that the records and materials generated in the test institution can reproduce the research work and provide evidence to prove that the test institution meets the requirements of GIL.P. These records and materials should be archived. 5.2.3 The test institution manager should ensure that appropriate archiving procedures are established. 5.2.4 The test institution manager should ensure that only authorized personnel have access to archives. Access should be controlled and the access procedures should be documented. Only when necessary (such as in an emergency), safety and technical personnel should be allowed to access the archives, but it should also be controlled and documented.
5.2.5 Where necessary, the test institution manager can inform the client of the requirements and responsibilities of the GLP principles regarding archiving. 5.3 Contracted archive agency
If the client or the test institution manager uses a contracted archive agency to store records and (or) materials of GLP research, the contracting party should ensure that the archives meet the requirements of the relevant parts of GB/T22278-2008. 5.4 Test Site Manager
Test site managers and test institution managers have the same responsibilities for archival facilities and archival procedures. 5.5 Project Manager
The project manager shall immediately transfer all records and materials related to the study to the archives during the study or after the study is completed (including the termination of the study). The project manager is responsible for the integrity of the study records and materials and ensures that all materials are archived before or after the study is completed.
5.6 Project Representative
GB/T22272—2008
Just after the study is completed or after a stage of the study, the project representative shall ensure that the records and materials under his/her responsibility are submitted to the project manager or the archive designated by the transfer office. The project representative shall report the transfer or archiving date to the project manager. 5.7 Archives Manager
5.7.1 The archives manager is responsible for the management, operation and procedures of archiving in accordance with the standard operating procedures and the requirements of GB/T22278-2008. 5.7.2 The archivist should also:
- ensure that access to archives is controlled; - ensure that records and materials are stored in an orderly manner and have an indexing system to facilitate retrieval; - ensure that the flow of archival records and materials into and out of the archives is properly managed and recorded. 5.7.3 When several people are required to perform archiving duties, they should work under the direction and supervision of the archivist. In some cases, specific archiving tasks, such as the management of electronic records, are delegated to the archivist. The specific duties, tasks and responsibilities of the archivist should be defined in the standard operating procedures. 5.8 Information Technology (IT) Personnel
Information technology personnel who perform archival operations (e.g., ensuring the integrity of electronic records) should be appropriately trained and their operations should comply with the requirements of GLP. Since archiving activities are the main responsibilities of the archivist, the IT personnel should work under the direction and supervision of the archivist. Because such an organizational structure is not feasible in modern companies, the cooperation between the archivist and the IT personnel should be ensured by other means, such as in the standard operating procedures or in a paper service agreement. 5.9 Quality Assurance (QA) Personnel
Quality assurance personnel are responsible for checking that all archiving processes comply with the principles of GLP, including checking archiving operations and procedures, including procedures for electronic records, equipment, stored records and materials. 6 Archives Facilities
Archives facilities should be designed and constructed to meet the requirements for the storage of archival records and materials. Archives facilities may be one or more buildings, rooms, safes, locked cabinets or other locations that can be secured. Archives facilities should have physical security measures to prevent unauthorized access to the records and materials stored, requiring the use of locks or electronic access systems. Components that provide only electronic archive storage should also have physical security measures, and computerized archive facilities should have procedures to prevent unauthorized access and virus protection. Buildings and rooms where archives are stored should be able to cope with local natural disasters, and risks such as flooding should be considered. Archives should be designed to protect archive contents from damage such as leaks from archive sewer pipes. In addition, the risk of fire and explosion should be minimized, and automatic fire and/or smoke detection systems should usually be installed. Management should also consider installing automatic fire extinguishing systems to minimize losses. If the archive facility is located in a location that is at risk of flooding, then consider installing water level detectors and/or drainage equipment. Archival facilities should be protected from rodents and vermin and, where appropriate, should have a pest control program. If necessary, back-up power should be provided for all equipment that requires strict temperature control (e.g. refrigerators and freezers). 6.1 Storage conditions for archives
6.1.1 Storage conditions should be designed to preserve, but not affect, the quality and integrity of the records and materials stored. For records and materials with special shelf life requirements, special storage conditions are required to maintain their integrity. For example, wet tissues, blocks and stock samples should be stored separately from paper documents and tissue sections.
6.1.2 Special materials require special storage conditions. For example, materials that require freezing, refrigeration, dry coal storage, etc., or materials that need to be protected from dust and magnetic interference under electronic media conditions. The requirements for special storage conditions should be clearly stated in the standard operating procedures of the test facility.
6.1.3 If it is clearly specified that special storage conditions are to be used, an environmental monitoring program should be operated in the archive storage area to ensure that the special storage conditions are achieved.
6.1.4 If continuous (automatic) monitoring systems are used (which can serve as alarms when specified limits are exceeded), then in accordance with GLP principles, these systems need to be regularly maintained, tested, calibrated, and records kept. 3
GB/T 22272-2008
6.2 Disaster Recovery
The testing agency and the contracted archive agency should establish corresponding procedures to minimize the damage to archived records and materials caused by adverse events. Common adverse events include: fire, power outages, extreme weather damage, floods, theft and vandalism. The procedures may include implementing protective measures, restoring and/or recovering lost or damaged records and materials, and rebuilding security systems. The plan should include useful and emergency contact information, the location of necessary equipment, and make records [such as: incident records, measures taken to resolve and/or recover. 7 Security
7.1 Physical and operational security
7.1.1 Archive facilities should be physically and operationally secure to prevent unauthorized access and alteration and to avoid loss of stored records and materials. Test facility managers should ensure security by taking appropriate measures and documenting them in the test facility's standard operating procedures. 7.1.2 Security measures to restrict access to electronic records are usually different from those applied to other types of records. Since many electronic storage media can be reused (e.g., erased and rewritten), measures should be taken to ensure that records are not altered or deleted. 7.2 Access to archives
According to normal archive work, archive access should be controlled and archive access should be limited to archive managers and archive staff. For emergency access (especially during non-working hours or for security reasons), emergency personnel may enter and/or operate archives alone. Otherwise, archive access personnel should be accompanied by archive managers or archive staff to access archives, and the process of access to archive storage areas should be recorded, and such records should be retained. For electronic records, the above restrictions may not apply, but minimal deletion or modification of electronic records in electronic records should be avoided. For electronic records, managers may grant read-only access to the general public. 8 Archival Procedures
8.1 Standard Operating Procedures (SOPs)
The following issues should be addressed in the archival operating procedures, whenever applicable: a) Access to archives;
Definition and description of archives;
Indexing procedures, including electronic records;
The conditions under which records and materials should be retained;
c) Procedures for receiving archived records and materials;
Access, transfer and return procedures for records and materials;
Responsibilities of archivists and archivists: Security measures for archival facilities, stored records and materials;
Climate control;
Shelf life;
k) Disposal of archived records and materials;
Existence of a contracted archiving service;
M) Whether to transfer to the client or third party: Disaster recovery;
o) Training requirements for archivists and archivists;
Frequency of archiving of non-specific research records;
Regular updating of electronic records.
8.2 Records and Materials Retained
Records retained include paper records, photographs, microfilm or microfilm sheets, computer media, designated monitoring, recorded data from automated instruments, or any other storage media containing non-clinical health or environmental safety study data. Retained materials include: agglutinated tissue, paraffin blocks, specimens, scribes, smears, test materials/retained samples, etc. Records and materials may belong to a specific study only or may be related to multiple studies. GB/T 22272—2008
8.2.1 Records and Materials for a Specific Study
Refers to records and materials generated in a single study conducted in accordance with the study plan. The project leader ensures that these records and materials are transferred to the archive immediately after the completion date of the study. These records may be reviewed to confirm the specific research results reported and to enable an overall evaluation of the study's compliance with GLP principles. The following are the records and materials for specific studies that need to be kept in archives: a) study plans, raw data, and final reports for each study; b) other documents and communications related to the study, such as delivery receipts, telephone records, faxes, etc.; c) test samples and reference materials; d) specimens; and certificates of analysis. 8.2.2 Facility Records and Materials These records and materials are generated by the test equipment or site and may be generated by a specific study or multiple studies completed by the test equipment or site. These records and materials need to be verified in order to reproduce the study and to make an overall assessment of the test equipment's continued compliance with GLP principles. Management should specify in standard operating procedures how and by what criteria these records and materials should be archived. The following are examples of laboratory records and materials that should be retained: a) Records of all inspections performed by quality assurance (QA) personnel; b) Master schedule;
Organization chart:
Floor/site plan; bzxz.net
Records of qualifications, training, experience, and job descriptions of personnel; e) Records and reports of instrument maintenance and calibration; f)
g) Validation documentation for computer systems; h) Historical documentation of all standard operating procedures; i) Environmental monitoring records;
|Test samples and reference materials, if used in more than one study; k) Certificates of analysis, if used in more than one study. 8.3 Indexing
GLP principles require that records and materials in archives be organized into references for orderly storage and rapid retrieval. The indexing system used should facilitate retrieval from study records and facility records to all information required to reproduce a study. 8.4 Archiving of Records and Materials
8.4.1 Upon completion of the study (including termination of the study), the project leader ensures that all study documents, data, related records and materials are archived in a timely manner. The project leader is responsible for the integrity of the study documents, data, related records and materials until these materials are archived. Once transferred to the archive, the trial site manager will be responsible for maintaining the integrity of the records and materials. The trial site manager should ensure the time period for transferring materials from the project leader to the archivist, and if there are regulations, they should comply with national regulations. 8.4.2 Before transferring records and materials to the archive, the project leader is responsible for establishing an archiving diary to confirm the integrity of the records and materials and ensure that all records and materials are transferred to the archive. Once the transfer is completed, the archivist and archival staff should check the integrity of the records and materials by comparing the catalog cancellation slip and confirming the receipt. 8.4.3 The trial site manager should ensure that non-study specific laboratory records, such as maintenance records, employee training records, organizational charts, etc. are archived regularly and should be clearly stated in the trial site's SOPs. The procedures for obtaining these non-study records and materials are similar to the procedures for obtaining study records and materials.
8.4.4 In multi-site studies, the archiving procedures for records and materials generated by individual sites before or at the start of each study should be consistent and documented.
8.4.5 The project representative should inform the project leader of the transfer of study materials to the archive. 5
GB/T22272—2008
8.5 Transfer
8.5.1 Sometimes it may be necessary to transfer archived records and materials from one archive facility to another archive facility in a different physical location. Before any transfer occurs, the archivist who transfers records and materials, including electronic records, should ensure that there is a documented agreement and transfer plan between the management of the test site, the management of the receiving site, and the client. The document should include detailed information on the records and materials to be transferred, the content of the contract, the address of the receiving site, and the method of transfer between the two locations. 8.5.2 The archivist should clearly describe the records and materials to be transferred in the corresponding transfer process document. The transfer of materials should be combined with the work of documenting, and the transfer between two locations should be carried out in such a way that the risk of loss or damage of records and materials is minimized. 8.5.3 The person receiving the transferred records and materials should check their compliance with the complete set of custody documents. Once received, the recipient is responsible for ensuring that the transferred records and materials are maintained and properly preserved. The parties involved in the transfer should retain copies of the custody documents. The transfer of archived materials between computer archive systems should be recorded and implemented according to the transfer plan. 8.6 Retention period
8.6.1 The retention period should comply with the regulations of the competent authority (acceptance). This retention period refers to the minimum period for which data should be retained and reviewed for safety studies conducted for the purpose of validating the registration of new products or marketed products. Records related to safety studies and other materials that can be retained for a long time should be retained as long as the main arm department requires a GLP review of each study. 8.6.2 When performing routine testing facility inspections, including the audit of ongoing studies. The supervisory department and/or its inspectors usually choose to inspect studies that have been completed or are ongoing since the last inspection, or the last two inspections (in some countries). If the appropriate competent authority does not specify a retention period, records and materials should be retained for at least three inspection cycles to allow inspectors to assess whether the testing facility is in compliance with GLP principles. For studies not submitted to the competent authority, it is acceptable (if justified) to dispose of specific study records and materials after the retention period has expired.
8.6.3 The original GLP requirement states that "for all studies except short-term studies, a reserve sample from each batch of test samples should be retained for analytical purposes". However, test samples and reference materials may be discarded when the quality of the material is no longer sufficient for evaluation, and obviously the best conditions should be selected for the storage of these samples. Disposal of test samples and reference materials or specimens before the end of the retention period should be justified and recorded accordingly.
8.6.4 Perishable specimens, such as freeze-dried preparations of blood smears, mixed tissues, can be discarded when they can no longer be reviewed or evaluated. For non-perishable specimens, the general principles apply. 8.6.5 Electronic media can be discarded when the media itself no longer allows evaluation (due to hardware or software problems). Such disposal shall be authorized and documented, and the electronic record shall be transferred and the loss of any record shall be recorded. 8.7 Access
8.7.1 Procedures for access to records and materials shall be established. These procedures shall specify the circumstances in which they may be removed from the archive (for inspection or regulatory purposes, by the client). The procedures shall specify who is allowed to retrieve the records and materials, who can authorize the removal of records and materials, and the time when the records and materials should be returned to the archive. 8.7.2 Viewing electronic records that cannot be changed, deleted, or copied to another computer system does not fall within the scope of "access".
8.7.3 GLP principles require that records and materials be properly recorded when they are placed in and removed from the archive. Reasonable mechanisms should be in place to enable the archive manager to track the entry and exit of records and materials and to determine which records and materials have not been returned within the specified time. Once returned to the archive, the archive manager or designated archive staff should check the integrity of the records and materials and confirm that they have not been modified. Management should be informed of any differences in the records and materials.
8.8 Disposal of Records and Materials
Before disposing of any archived records and materials, authorization should be obtained from the test facility management and, in some cases, the client. The reason for the disposal should be recorded appropriately and the quality assurance personnel should be informed. Disposal of archived records and materials should be recorded appropriately. 9 Archiving of Electronic Records
Although the requirements for archiving electronic records are the same as those for archiving other records, there are additional characteristics of electronic record archiving. This is described in detail below. Management ensures that standard operating procedures are established for archiving electronic media to ensure that electronic media are archived in a secure GLP environment.
9.1 Decision to Store Records Electronically
The decision to store records in electronic form is important. The long-term retention of electronic records may affect the choice of storage media, because damage to the storage media may result in permanent loss of records. Computer technology is developing rapidly, and devices that can be used to read storage media today may not be available in the future. Electronic records should be stored in a readable format during the applicable storage period. 9.2 Storage Media
Records are transferred through a computer system to storage media, such as tapes, disks, CDs or optical disks, which may be used for physical archival purposes. Archival procedures should include consideration of the additional management that may be imposed on the movement of electronic records from old to new media. Consideration should be given to future access to data or records stored on these media, which may require special storage conditions, such as protection from magnetic fields. 9.3 Designated Archival Areas on Computer Systems Electronic records may be moved from the generating portion of a computer processing system to a separate, secure archival area (physically separate, such as an archival records system) or clearly designated as an archival area (logically separate, such as a database records system) on the same computer. Records should be "locked" to prevent them from being altered or deleted without prior knowledge. Records stored in this manner should be managed by a designated archivist and in a manner consistent with other forms of records.
9.4 Dedicated electronic archival system
9.4,1 Records may be transferred from the computer system from which they were obtained or manipulated to an independent, dedicated electronic archiving system. All data relevant to the reproduction of the research should be transferred. This includes, but is not limited to, raw data, metadata, audit trails, electronic signatures, and related hardware and software that will allow all records to be accessed in the future. 9.4.2 Ideally, the archivist is also the system administrator of the electronic archiving system. In practice, it is generally accepted that electronic archiving systems are managed by information technology (IT) personnel. The basic responsibilities of the archivist are to manage the archives. , but its important task is to help ensure that regulatory requirements are met. Therefore, the test facility manager should ensure cooperation and coordination between the archive manager and information technology personnel. 9.4.3 Information technology personnel should comply with procedures agreed upon with the archive manager and (or test facility manager. 9.5 Maintenance and preservation of electronic records
9.5.1 Electronic records should have a storage process to ensure future use, otherwise the electronic records will be at risk. The storage procedure should ensure that basic information is kept intact and available within a specific retention period. If the record medium requires a process to ensure that the retained records are stored in a readable format, then appropriate equipment should be provided so that the records can be continuously read. If reading cannot be guaranteed, it is necessary to consider transferring the data from one medium to another. 9.5.2 If electronic records must be transferred, the transfer process should be fully registered and verified before the original records are deleted or destroyed to ensure that the records have been transferred accurately. If it is not possible to transfer the records to a new electronic medium, they should be converted to paper records. As part of the archive retention plan, electronic archives should be backed up. 10 Quality Assurance
Archive facilities and archiving processes are an important part of the laboratory's compliance with GLP requirements. Therefore, they should be subject to routine quality assurance (QA) inspections and audits. When archival records and materials need to be transferred, the transfer process should be supervised by performing direct quality assurance inspections.
11 Contracted Archive Services
GLP principles require that the laboratory should have an archive that can provide safe storage for records and materials. Usually the laboratory itself is equipped with archive facilities, but this does not exclude contracted archive facilities. In this case, this standard also applies to contracted archive facilities. Contracted archive facilities are involved in GLP research and should be subject to quality assurance plans, inspections and reviews by the testing agency to evaluate the degree of compliance with GLP principles. The following factors should be considered when using contracted archive facilities:7
GB/T 22272—2008
11.1 Contract and/or Service Level Agreement
A formal agreement should be provided to detail the service levels and service conditions provided by the contracted archive agency. This agreement should include the description of archived data and materials, the transfer, flow, use of archived records and materials by the contracted archive agency, the services provided by the contracted archive agency (such as regular inspection of wet tissue containers), security, storage conditions, storage period, methods of access and/or use and methods of return and/or disposal, quality assurance activities and responsibilities, and other matters that need to be considered as stated in the agreement. The contracted archive agency should follow its existing relevant or standard operating procedures provided by the test agency manager, which should be specifically stated in the agreement. 11.2 Access arrangements
The following procedures should be specified: how and when the provider of records and/or materials can access the stored records and/or materials. Any such access should be approved and recorded. 11.3 Storage conditions
The storage conditions and procedures followed by the contracted archive agency should be consistent with those of the archives of the research institutes operating in accordance with the principles of GLP. This includes: designating a qualified archive manager, having a written and approved standard operating procedure for archiving, and specifying appropriate storage areas to prevent damage and loss of stored records and materials.
11.4 Inspections
The contracted archive agency should receive regular inspections from the quality assurance organization, the representative research institute, and the client to ensure that the conditions of the service level agreement are met and that the systems and procedures operated by the contracted archive agency meet the requirements of their SOPs and the principles of GLP. 12 Termination of archives
12.1 Principles
GB/T22278-2008 3.10.5 states: If a research institute or contracted archive agency is about to cease operations and there is no legal successor, the archives should be transferred to the archives of the research client. 12.2 Actions to be taken
If a laboratory or testing site does not follow the principles of GLP in its records management or ceases operations, the following actions should be taken:
12.2.1 The laboratory should promptly notify the appropriate national GLP compliance monitoring authority. 12.2.2 Upon a decision to close the records or if operations cease, the laboratory management should ensure that the client is informed as soon as possible. The client should ensure that all data and materials related to the study are transferred to another institution that complies with the requirements of the GLP records management rules and are retained for the period specified by the relevant authorities.
12.2.3 Records of non-specific studies or records related to studies initiated by multiple clients should be retained in accordance with the principles of GLP. The laboratory management should agree with the client on how to ensure that data and materials are stored in an archive that complies with the requirements of GLP after the laboratory is closed, and the retention period should be in accordance with the regulations of the competent authority. The client's access to these records and materials related to the study should be granted and the access should be recorded. 12.3 Inspection by the Supervisory Authority
After the records are transferred to the new archive facility, the GLP Supervisory Authority will conduct normal inspections of the new archive facility. If records or data are transferred to an archive facility in another country, the GLP Supervisory Authority of that country should be notified. 8
参考文献
GB/T22272--2008
[1] OECD Principles of Good LaboratoryPractice(as revised in 1997),ENV/MC/CHEM(98)17,OECD, Paris, 19g8, (No. 1 in OECD Series on Good Laboratory Practice and Campliance Monito-ring).
Ta] Revised Guidance fur the Conduct of Laboratory Inspections and Study Audits, Environment Monograph No.111,EVV/GD/(95)67,OECD,Paris,1995(No,3 inOECD Series on GoodLahoratory Practice and Compliance Monitoring).[3] The Application of The Principles of GLP ta Computerised Systerns, Environment Monugraph No. 116, OECD/GD(95)115, OECD, Paris, 1995.(No. 10 in OECD Series on Good Laboratory Practice and Compliance Monitoring),9
GB/T22272-2008
National Standard of the People's Republic of China
Recommended Document on Good Laboratory Practice
Establish and manage archives that comply with the principles of good laboratory practice
GB/T 22272—2008
Published and distributed by China Standards Press
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Report phone: (010) 685335331 Contract and/or Service Level Agreement
A formal agreement should be provided that details the service levels and conditions to be provided by the contracted archive organization. This agreement should include the description of archived data and materials, the transfer, flow, use of archived records and materials by the contracted archive organization, services provided by the contracted archive organization (e.g., periodic testing of wet tissue containers), security, storage conditions, storage periods, methods of access and/or use, and methods of return and/or disposal, quality assurance activities and responsibilities, and any other matters that are considered necessary as stated in the agreement. The contracted archive organization should follow its existing standard operating procedures, which should be provided by the relevant agency or the study site management, and this should be specifically noted in the agreement. 11.2 Access Arrangements
Procedures should be set out as to how and when the provider of records and/or materials can access stored records and/or materials. Any such access should be approved and documented. 11.3 Storage Conditions
The storage conditions and procedures adhered to by the contracted archive organization should be consistent with those of the study site archives operating in accordance with the principles of GLP. Including: designating qualified archive managers, having written and approved archiving standard operating procedures, specifying appropriate storage areas, and preventing damage and loss of stored records and materials.
11.4 Inspection
The contracted archive agency should accept regular inspections from the quality assurance agency, the representative test agency, and the client to ensure that the conditions of the service level agreement are met and that the systems and procedures operated by the contracted archive agency meet the requirements of their SOPs and GLP principles. 12 Termination of archives
12.1 Principles
GB/T22278-2008 3.10.5 stipulates: If a test agency or contracted archive agency is about to cease operations and there is no legal successor, the archives should be transferred to the archives of the research client. 12.2 Measures to be taken
If a test agency or test site does not follow the principles of GLP in archive management or ceases operation, the following measures should be taken:
12.2.1 The test agency should promptly notify the corresponding national GLP compliance supervision department. 12.2.2 Upon decision to close the archives or if operations cease, the site manager shall ensure that the client is informed as soon as possible and that the client ensures that all data and materials related to the study are transferred to another facility that complies with the GLP archive management rules and are retained for the period specified by the competent authority.
12.2.3 Records of non-specific studies or records related to studies initiated by multiple clients should be retained in accordance with the principles of GLP. The site manager should agree with the client on how to ensure that data and materials are stored in an archive facility that complies with GLP requirements after the site is closed, and the retention period should be in accordance with the regulations of the competent authority. The client's access to these records and materials related to the study should be granted and the access should be recorded. 12.3 Inspection by the Supervisory Authority
After the archives are transferred to the new archive facility, the GLP supervisory authority will conduct normal inspections of the new archive facility. If records or data are transferred to an archive facility in another country, the GLP supervisory authority in that country should be notified. 8
参考文献
GB/T22272--2008
[1] OECD Principles of Good LaboratoryPractice(as revised in 1997),ENV/MC/CHEM(98)17,OECD, Paris, 19g8, (No. 1 in OECD Series on Good Laboratory Practice and Campliance Monito-ring).
Ta] Revised Guidance fur the Conduct of Laboratory Inspections and Study Audits, Environment Monograph No.111,EVV/GD/(95)67,OECD,Paris,1995(No,3 inOECD Series on GoodLahoratory Practice and Compliance Monitoring).[3] The Application of The Principles of GLP ta Computerised Systerns, Environment Monugraph No. 116, OECD/GD(95)115, OECD, Paris, 1995.(No. 10 in OECD Series on Good Laboratory Practice and Compliance Monitoring),9
GB/T22272-2008
National Standard of the People's Republic of China
Recommended Document on Good Laboratory Practice
Establish and manage archives that comply with the principles of good laboratory practice
GB/T 22272—2008
Published and distributed by China Standards Press
No. 16, Sanlihebei Street, Fuxingmenwai, Beijing
Postal Code: 100045
Website spc, net. cn
Tel: 6852394668517548
Printed by China Standard Press Qinhuangdao Printing Factory Distributed by Xinhua Bookstores in various places
Format 880×12301/16 Printing sheet 1 Word count 18,000 words First edition in November 2008 First printing in November 2008 Book number: 155066-1-33859 Price 16.00 yuan If there is any printing error, the publishing center of our company will replace it. Copyright is exclusive. Infringement will be investigated
Report phone: (010) 685335331 Contract and/or Service Level Agreement
A formal agreement should be provided that details the service levels and conditions to be provided by the contracted archive organization. This agreement should include the description of archived data and materials, the transfer, flow, use of archived records and materials by the contracted archive organization, services provided by the contracted archive organization (e.g., periodic testing of wet tissue containers), security, storage conditions, storage periods, methods of access and/or use, and methods of return and/or disposal, quality assurance activities and responsibilities, and any other matters that are considered necessary as stated in the agreement. The contracted archive organization should follow its existing standard operating procedures, which should be provided by the relevant agency or the study site management, and this should be specifically noted in the agreement. 11.2 Access Arrangements
Procedures should be set out as to how and when the provider of records and/or materials can access stored records and/or materials. Any such access should be approved and documented. 11.3 Storage Conditions
The storage conditions and procedures adhered to by the contracted archive organization should be consistent with those of the study site archives operating in accordance with the principles of GLP. Including: designating qualified archive managers, having written and approved archiving standard operating procedures, specifying appropriate storage areas, and preventing damage and loss of stored records and materials.
11.4 Inspection
The contracted archive agency should accept regular inspections from the quality assurance agency, the representative test agency, and the client to ensure that the conditions of the service level agreement are met and that the systems and procedures operated by the contracted archive agency meet the requirements of their SOPs and GLP principles. 12 Termination of archives
12.1 Principles
GB/T22278-2008 3.10.5 stipulates: If a test agency or contracted archive agency is about to cease operations and there is no legal successor, the archives should be transferred to the archives of the research client. 12.2 Measures to be taken
If a test agency or test site does not follow the principles of GLP in archive management or ceases operation, the following measures should be taken:
12.2.1 The test agency should promptly notify the corresponding national GLP compliance supervision department. 12.2.2 Upon decision to close the archives or if operations cease, the site manager shall ensure that the client is informed as soon as possible and that the client ensures that all data and materials related to the study are transferred to another facility that complies with the GLP archive management rules and are retained for the period specified by the competent authority.
12.2.3 Records of non-specific studies or records related to studies initiated by multiple clients should be retained in accordance with the principles of GLP. The site manager should agree with the client on how to ensure that data and materials are stored in an archive facility that complies with GLP requirements after the site is closed, and the retention period should be in accordance with the regulations of the competent authority. The client's access to these records and materials related to the study should be granted and the access should be recorded. 12.3 Inspection by the Supervisory Authority
After the archives are transferred to the new archive facility, the GLP supervisory authority will conduct normal inspections of the new archive facility. If records or data are transferred to an archive facility in another country, the GLP supervisory authority in that country should be notified. 8
参考文献
GB/T22272--2008
[1] OECD Principles of Good LaboratoryPractice(as revised in 1997),ENV/MC/CHEM(98)17,OECD, Paris, 19g8, (No. 1 in OECD Series on Good Laboratory Practice and Campliance Monito-ring).
Ta] Revised Guidance fur the Conduct of Laboratory Inspections and Study Audits, Environment Monograph No.111,EVV/GD/(95)67,OECD,Paris,1995(No,3 inOECD Series on GoodLahoratory Practice and Compliance Monitoring).[3] The Application of The Principles of GLP ta Computerised Systerns, Environment Monugraph No. 116, OECD/GD(95)115, OECD, Paris, 1995.(No. 10 in OECD Series on Good Laboratory Practice and Compliance Monitoring),9
GB/T22272-2008
National Standard of the People's Republic of China
Recommended Document on Good Laboratory Practice
Establish and manage archives that comply with the principles of good laboratory practice
GB/T 22272—2008
Published and distributed by China Standards Press
No. 16, Sanlihebei Street, Fuxingmenwai, Beijing
Postal Code: 100045
Website spc, net. cn
Tel: 6852394668517548
Printed by China Standard Press Qinhuangdao Printing Factory Distributed by Xinhua Bookstores in various places
Format 880×12301/16 Printing sheet 1 Word count 18,000 words First edition in November 2008 First printing in November 2008 Book number: 155066-1-33859 Price 16.00 yuan If there is any printing error, the publishing center of our company will replace it. Copyright is exclusive. Infringement will be investigated
Report phone: (010) 685335333 Inspection by the Supervisory Department
After the records are transferred to the new archive facility, the GLP Supervisory Department will conduct normal inspections of the new archive facility. If records or data are transferred to an archive facility in another country, the GLP Supervisory Department of that country should be notified. 8
参考文献
GB/T22272--2008
[1] OECD Principles of Good LaboratoryPractice(as revised in 1997),ENV/MC/CHEM(98)17,OECD, Paris, 19g8, (No. 1 in OECD Series on Good Laboratory Practice and Campliance Monito-ring).
Ta] Revised Guidance fur the Conduct of Laboratory Inspections and Study Audits, Environment Monograph No.111,EVV/GD/(95)67,OECD,Paris,1995(No,3 inOECD Series on GoodLahoratory Practice and Compliance Monitoring).[3] The Application of The Principles of GLP ta Computerised Systerns, Environment Monugraph No. 116, OECD/GD(95)115, OECD, Paris, 1995.(No. 10 in OECD Series on Good Laboratory Practice and Compliance Monitoring),9
GB/T22272-2008
National Standard of the People's Republic of China
Recommended Document on Good Laboratory Practice
Establish and manage archives that comply with the principles of good laboratory practice
GB/T 22272—2008
Published and distributed by China Standards Press
No. 16, Sanlihebei Street, Fuxingmenwai, Beijing
Postal Code: 100045
Website spc, net. cn
Tel: 6852394668517548
Printed by China Standard Press Qinhuangdao Printing Factory Distributed by Xinhua Bookstores in various places
Format 880×12301/16 Printing sheet 1 Word count 18,000 words First edition in November 2008 First printing in November 2008 Book number: 155066-1-33859 Price 16.00 yuan If there is any printing error, the publishing center of our company will replace it. Copyright is exclusive. Infringement will be investigated
Report phone: (010) 685335333 Inspection by the Supervisory Department
After the records are transferred to the new archive facility, the GLP Supervisory Department will conduct normal inspections of the new archive facility. If records or data are transferred to an archive facility in another country, the GLP Supervisory Department of that country should be notified. 8
参考文献
GB/T22272--2008
[1] OECD Principles of Good LaboratoryPractice(as revised in 1997),ENV/MC/CHEM(98)17,OECD, Paris, 19g8, (No. 1 in OECD Series on Good Laboratory Practice and Campliance Monito-ring).
Ta] Revised Guidance fur the Conduct of Laboratory Inspections and Study Audits, Environment Monograph No.111,EVV/GD/(95)67,OECD,Paris,1995(No,3 inOECD Series on GoodLahoratory Practice and Compliance Monitoring).[3] The Application of The Principles of GLP ta Computerised Systerns, Environment Monugraph No. 116, OECD/GD(95)115, OECD, Paris, 1995.(No. 10 in OECD Series on Good Laboratory Practice and Compliance Monitoring),9
GB/T22272-2008
National Standard of the People's Republic of China
Recommended Document on Good Laboratory Practice
Establish and manage archives that comply with the principles of good laboratory practice
GB/T 22272—2008
Published and distributed by China Standards Press
No. 16, Sanlihebei Street, Fuxingmenwai, Beijing
Postal Code: 100045
Website spc, net. cn
Tel: 6852394668517548
Printed by China Standard Press Qinhuangdao Printing Factory Distributed by Xinhua Bookstores in various places
Format 880×12301/16 Printing sheet 1 Word count 18,000 words First edition in November 2008 First printing in November 2008 Book number: 155066-1-33859 Price 16.00 yuan If there is any printing error, the publishing center of our company will replace it. Copyright is exclusive. Infringement will be investigated
Report phone: (010) 68533533
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