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Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (Text with EEA relevance)
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Government and industry are concerned about the quality of non-clinical health and environmental safety studies upon which hazard assessments are based. As a consequence, OECD Member States have established criteria for the performance of these studies.
To avoid different schemes of implementation that could impede international trade in chemicals, OECD Member States have pursued international harmonisation of test methods and good laboratory practice. In 1979 and 1980 an international group of experts, established under the special programme on the control of chemicals, developed the ‘OECD principles of good laboratory practice’ (GLP), utilising common managerial and scientific practices and experience from various national and international sources. These principles of GLP were adopted by the OECD Council in 1981, as an Annex to the Council Decision on the mutual acceptance of data in the assessment of chemicals (C(81) 30 (final)).
In 1995 and 1996, a new group of experts was formed to revise and update the principles. The current document is the result of the consensus reached by that group. It cancels and replaces the original principles adopted in 1981.
The purpose of these principles of good laboratory practice is to promote the development of quality test data. Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources. The application of these principles should help to avoid the creation of technical barriers to trade, and further improve the protection of human health and the environment.
These principles of good laboratory practice should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organisms. The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human health and/or the environment.
Non-clinical health and environmental safety studies covered by the principles of good laboratory practice include work conducted in the laboratory, in greenhouses, and in the field.
Unless specifically exempted by national legislation, these principles of good laboratory practice apply to all non-clinical health and environmental safety studies required by regulation for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals.
Good laboratory practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
ensure that a statement exists which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by these principles of good laboratory practice;
ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study;
ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual;
ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions;
ensure that appropriate and technically valid standard operating procedures are established and followed, and approve all original and revised standard operating procedures;
ensure that there is a quality assurance programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with these principles of good laboratory practice;
ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the study director before the study is initiated. Replacement of a study director should be done according to established procedures, and should be documented;
ensure, in the event of a multisite study, that, if needed, a principal investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a principal investigator should be done according to established procedures, and should be documented;
ensure documented approval of the study plan by the study director;
ensure that the study director has made the approval study plan available to the quality assurance personnel;
ensure the maintenance of a historical file of all standard operating procedures;
ensure that an individual is identified as responsible for the management of the archive(s);
ensure the maintenance of a master schedule;
ensure that test facility supplies meet requirements appropriate to their use in a study;
ensure for a multisite study that clear lines of communication exist between the study director, principal investigator(s), the quality assurance programme(s) and study personnel;
ensure that test and reference items are appropriately characterised;
establish procedures to ensure that computerised systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with these principles of good laboratory practice.
approve the study plan and any amendments to the study plan by dated signature;
ensure that the quality assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the quality assurance personnel as required during the conduct of the study;
ensure that study plans and amendments and standard operating procedures are available to study personnel;
ensure that the study plan and the final report for a multisite study identify and define the role of any principal investigator(s) and any test facilities and test sites involved in the conduct of the study;
ensure that the procedures specified in the study plan are followed, and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from standard operating procedures during the conduct of the study;
ensure that all raw data generated are fully documented and recorded;
ensure that computerised systems used in the study have been validated;
sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these principles of good laboratory practice;
ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.
The principal investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable principles of good laboratory practice.
The responsibilities of the quality assurance personnel include, but are not limited to, the following functions. They should:
maintain copies of all approved study plans and standard operating procedures in use in the test facility and have access to an up-to-date copy of the master schedule;
verify that the study plan contains the information required for compliance with these principles of good laboratory practice. This verification should be documented;
conduct inspections to determine if all studies are conducted in accordance with these principles of good laboratory practice. Inspections should also determine that study plans and standard operating procedures have been made available to study personnel and are being followed.
Inspections can be of three types as specified by quality assurance programme standard operating procedures:
study-based inspections,
facility-based inspections,
process-based inspections.
Records of such inspections should be retained;
inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies;
promptly report any inspection results in writing to management and to the study director, and to the principal investigator(s) and the respective management, when applicable;
prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the study director and principal investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.
Archive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration.
Handling and disposal of wastes should be carried out in such a way as not to jeopardise the integrity of studies. This includes provision for appropriate collection, storage and disposal facilities, and decontamination and transportation procedures.
Coding of studies, data collection, preparation of reports, indexing systems, handling of data, including the use of computerised systems.
Room preparation and environmental room conditions for the test system.
Procedures for receipt, transfer, proper placement, characterisation, identification and care of the test system.
Test system preparation, observations and examinations, before, during and at the conclusion of the study.
Handling of test system individuals found moribund or dead during the study.
Collection, identification and handling of specimens including necropsy and histopathology.
Siting and placement of test systems in test plots.
Amendments to the study plan should be justified and approved by dated signature of the study director and maintained with the study plan.
Deviations from the study plan should be described, explained, acknowledged and dated in a timely fashion by the study director and/or principal investigator(s) and maintained with the study raw data.
The study plan should contain, but not be limited to the following information:
A descriptive title
A statement which reveals the nature and purpose of the study
Identification of the test item by code or name (IUPAC; CAS number, biological parameters, etc.)
The reference item to be used.
Name and address of the sponsor
Name and address of any test facilities and test sites involved
Name and address of the study director
Name and address of the principal investigator(s), and the phase(s) of the study delegated by the study director and under the responsibility of the principal investigator(s).
The date of approval of the study plan by signature of the study director. The date of approval of the study plan by signature of the test facility management and sponsor if required by national regulation or legislation in the country where the study is being performed.
The proposed experimental starting and completion dates.
Reference to the OECD test guideline or other test guideline or method to be used.
The justification for selection of the test system
Characterisation of the test system, such as the species, strain, substrain, source of supply, number, body weight range, sex, age and other pertinent information
The method of administration and the reason for its choice
The dose levels and/or concentration(s), frequency, and duration of administration/application;
Detailed information on the experimental design, including a description of the chronological procedure of the study, all methods, materials and conditions, type and frequency of analysis, measurements, observations and examinations to be performed, and statistical methods to be used (if any).
The final report should include, but not be limited to, the following information:
A descriptive title
Identification of the test item by code or name (IUPAC, CAS number, biological parameters, etc.)
Identification of the reference item by name
Characterisation of the test item including purity, stability and homogeneity.
Name and address of the sponsor
Name and address of any test facilities and test sites involved
Name and address of the study director
Name and address of the principal investigator(s) and the phase(s) of the study delegated, if applicable
Name and address of scientists having contributed reports to the final report.
A quality assurance programme statement listing the types of inspections made and their dates, including the phase(s) inspected, and the dates any inspection results were reported to management and to the study director and principal investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.
Description of methods and materials used
Reference to OECD test guideline or other test guideline or method.
the study plan, raw data, samples of test and reference items, specimens, and the final report of each study;
records of all inspections performed by the quality assurance programme, as well as master schedules;
records of qualifications, training, experience and job descriptions of personnel;
records and reports of the maintenance and calibration of apparatus;
validation documentation for computerised systems;
the historical file of all standard operating procedures;
environmental monitoring records.
In the absence of a required retention period, the final disposition of any study materials should be documented. When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation.
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