http://www.legislation.gov.uk/id/eudr/2004/10/contents

SECTION IINTRODUCTIONPreface 1.Scope 2.Definition of terms 2.1.Good laboratory practice 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...2.4.Terms concerning the test item 1.Test item means an article that is the subject of...2.Reference item (control item) means any article used to provide...3.Batch means a specific quantity or lot of a test...4.Vehicle means any agent which serves as a carrier used...SECTION IIGOOD LABORATORY PRACTICE PRINCIPLES1.Test facility organisation and personnel 1.1.Test facility management's responsibilities 1.Each test facility management should ensure that these principles of...2.At a minimum it should: 3.When a phase(s) of a study is conducted at a...1.2.Study director's responsibilities 1.The study director is the single point of study control...2.These responsibilities should include, but not be limited to, the...1.3.Principal investigator's responsibilities 1.4.Study personnel's responsibilities 1.All personnel involved in the conduct of the study must...2.Study personnel will have access to the study plan and...3.All study personnel are responsible for recording raw data promptly...4.Study personnel should exercise health precautions to minimise risk to...2.Quality assurance programme 2.1.General 1.The test facility should have a documented quality assurance programme...2.The quality assurance programme should be carried out by an...3.This individual(s) should not be involved in the conduct of...2.2.Responsibilities of the quality assurance personnel 3.Facilities 3.1.General 1.The test facility should be of suitable size, construction and...2.The design of the test facility should provide an adequate...3.2.Test system facilities 1.The test facility should have a sufficient number of rooms...2.Suitable rooms or areas should be available for the diagnosis,...3.There should be storage rooms or areas as needed for...3.3.Facilities for handling test and reference items 1.To prevent contamination or mix-ups, there should be separate rooms...2.Storage rooms or areas for the test items should be...3.4.Archive facilities 3.5.Waste disposal 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...5.Test systems 5.1.Physical/chemical 1.Apparatus used for the generation of physical/chemical data should be...2.The integrity of the physical/chemical test systems should be ensured....5.2.Biological 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...6.Test and reference items 6.1.Receipt, handling, sampling and storage 1.Records including test item and reference item characterisation, date of...2.Handling, sampling, and storage procedures should be identified in order...3.Storage container(s) should carry identification information, expiry date, and specific...6.2.Characterisation 1.Each test and reference item should be appropriately identified (e.g....2.For each study, the identity, including batch number, purity, composition,...3.In cases where the test item is supplied by the...4.The stability of test and reference items under storage and...5.If the test item is administered or applied in a...6.A sample for analytical purposes from each batch of test...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...8.Performance of the study 8.1.Study plan 1.For each study, a written plan should exist prior to...2.Amendments to the study plan should be justified and approved...3.For short-term studies, a general study plan accompanied by a...8.2.Content of the study plan 8.3.Conduct of the study 1.A unique identification should be given to each study. All...2.The study should be conducted in accordance with the study...3.All data generated during the conduct of the study should...4.Any change in the raw data should be made so...5.Data generated as a direct computer input should be identified...9.Reporting of study results 9.1.General 1.A final report should be prepared for each study. In...2.Reports of principal investigators or scientists involved in the study...3.The final report should be signed and dated by the...4.Corrections and additions to a final report should be in...5.Reformatting of the final report to comply with the submission...9.2.Content of the final report 10.Storage and retention of records and materials 10.1.The following should be retained in the archives for the...10.2.Material retained in the archives should be indexed so as...10.3.Only personnel authorised by management should have access to the...10.4.If a test facility or an archive contracting facility goes...

ANNEX II

PART APART B

ANNEX III

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)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee1,

Acting in accordance with the procedure laid down in Article 251 of the Treaty2,

Whereas:

(1)

Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of principles of good laboratory practice and the verification of their applications for tests on chemical substances3 has been significantly amended. In the interests of clarity and rationality the said Directive should be codified.

(2)

Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances4 requires tests to be carried out on chemical substances in order to enable their potential risk to man and the environment to be determined.

(3)

When the active substances in pesticides undergo tests they should do so in accordance with Directive 67/548/EEC.

(4)

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products5 and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use6 lay down that non-clinical tests on pharmaceutical products are to be carried out in accordance with the principles of good laboratory practice (GLP) in force in the Community for chemical substances, compliance with which is also required by other Community legislation.

(5)

The methods to be used for these tests are laid down in Annex V to Directive 67/548/EEC.

(6)

It is necessary to comply with the principles of GLP in carrying out the tests laid down by Directive 67/548/EEC so as to ensure that the results are comparable and of high quality.

(7)

The resources devoted to the tests should not be wasted by having to repeat tests owing to differences in laboratory practice from one Member State to another.

(8)

The Council of the Organisation for Economic Cooperation and Development (OECD) took a Decision on 12 May 1981 on the mutual acceptance of data for the evaluation of chemical products. It issued a recommendation on 26 July 1983 concerning the mutual recognition of compliance with GLP. The principles of GLP have been modified by OECD Council Decision (C(97) 186 (final)).

(9)

Animal protection requires that the number of experiments conducted on animals be restricted. Mutual recognition of the results of tests obtained using standard and recognised methods is an essential condition for reducing the number of experiments in this area.

(10)

It is necessary to set up a procedure allowing rapid adaptation of the principles of GLP.

(11)

This Directive should be without prejudice to the obligations of the Member States concerning the time limits for transposition of the directives set out in Annex II, part B,

HAVE ADOPTED THIS DIRECTIVE: