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Article 1.(1) Member States shall take all measures necessary to ensure...
Article 2.When submitting results, the laboratories referred to in Article 1...
Article 3.(1) Member States shall adopt the measures necessary for verification...
Article 3a.The Commission may adapt Annex I to technical progress, with...
Article 4.(1) The Commission shall be assisted by the Committee established...
Article 5.(1) Where Community provisions require application of the principles of...
Article 6.Directive 87/18/EEC is hereby repealed, without prejudice to the obligations...
Article 7.This Directive shall enter into force on the 20th day...
THE OECD PRINCIPLES OF GOOD LABORATORY PRACTICE (GLP)
2.2. Terms concerning the organisation of a test facility
1. Test facility means the persons, premises and operational unit(s) that...
2. Test site means the location(s) at which a phase(s) of...
3. Test facility management means the person(s) who has the authority...
4. Test site management (if appointed) means the person(s) responsible for...
5. Sponsor means an entity which commissions, supports and/or submits a...
6. Study director means the individual responsible for the overall conduct...
7. Principal investigator means an individual who, for a multisite study,...
8. Quality assurance programme: means a defined system, including personnel, which...
9. Standard operating procedures (SOPs) means documented procedures which describe how...
10. Master schedule means a compilation of information to assist in...
2.3. Terms concerning the non-clinical health and environmental safety study
1. Non-clinical health and environmental safety study, henceforth referred to simply...
2. Short-term study means a study of short duration with widely...
3. Study plan means a document which defines the objectives and...
4. Study plan amendment means an intended change to the study...
5. Study plan deviation means an unintended departure from the study...
6. Test system means any biological, chemical or physical system, or...
7. Raw data means all original test facility records and documentation,...
8. Specimen means any material derived from a test system for...
9. Experimental starting date means the date on which the first...
10. Experimental completion date means the last date on which data...
11. Study initiation date means the date the study director signs...
12. Study completion date means the date the study director signs...
SECTION II GOOD LABORATORY PRACTICE PRINCIPLES
1. Test facility organisation and personnel
4. Apparatus, material, and reagents
1. Apparatus, including validated computerised systems, used for the generation, storage...
2. Apparatus used in a study should be periodically inspected, cleaned,...
3. Apparatus and materials used in a study should not interfere...
4. Chemicals, reagents, and solutions should be labelled to indicate identity...
1. Proper conditions should be established and maintained for the storage,...
2. Newly received animal and plant test systems should be isolated...
3. Records of source, date of arrival, and arrival condition of...
4. Biological test systems should be acclimatised to the test environment...
5. All information needed to properly identify the test systems should...
6. During use, housing or containers for test systems should be...
7. Test systems used in field studies should be located so...
7. Standard operating procedures
1. A test facility should have written standard operating procedures approved...
2. Each separate test facility unit or area should have immediately...
3. Deviations from standard operating procedures related to the study should...
4. Standard operating procedures should be available for, but not be...