Good Laboratory Practice Regulations 1997
| Jurisdiction | UK Non-devolved |
| Citation | SI 1997/654 |
| Year | 1997 |
1997 No. 654
HEALTH AND SAFETY
The Good Laboratory Practice Regulations 1997
Made 6th March 1997
Laid before Parliament 7th March 1997
Coming into force 1st April 1997
The Secretary of State, being the Minister designated1for the purposes of section 2(2) of the European Communities Act 19722in relation to measures relating to the control of laboratories carrying out tests on chemical products, in exercise of the powers conferred by the said section 2(2) and, with the consent of the Treasury, the powers conferred by section 56(1) and (2) of the Finance Act 19733, and of all other powers enabling him in that behalf, hereby makes the following Regulations—
Citation and commencement
1. These Regulations may be cited as the Good Laboratory Practice Regulations 1997 and shall come into force on 1st April 1997.
Interpretation
2.—(1) In these Regulations, unless the context otherwise requires—
“batch” means a specific quantity or lot of a test or reference substance produced during a defined cycle of manufacture in such a way that it could be expected to be of a uniform character and should be designated as such;
“the GLP Inspection and Verification Directive” means Council Directive 88/320/EECof 9th June 1988 on the inspection and verification of Good Laboratory Practice (GLP)4, as amended by Commission Directive 90/18/EECof 18th December 1989 adapting to technical progress the Annex to Council Directive 88/320/EECon the inspection and verification of good laboratory practice (GLP)5;
“laboratory” means a test facility which conducts or which intends to conduct safety studies;
“monitoring authority” means any national authority which is responsible (either solely or jointly with other such authorities) for monitoring adherence to the principles of good laboratory practice;
“OECD” means the Organisation for Economic Co-operation and Development;
“OECD test guideline” means a test guideline which the OECD has recommended for use in its member countries;
“operator”, in relation to a laboratory, means the person having control of the laboratory;
“premises”, in relation to a laboratory, includes field sites at which safety studies are conducted;
“principles of good laboratory practice” means the principles of good laboratory practice set out in Schedule 1 to these Regulations, which are based on the principles of good laboratory practice contained in Annex 2 to the Decision of the Council of the OECD of 12th May 1981 on the mutual acceptance of data for the evaluation of chemical products6, read with the guidance on inspection procedures and study audits set out in Schedule 2 to these Regulations, which is based on Annex B of the GLP Inspection and Verification Directive;
“quality assurance programme” means an internal control system designed to ascertain that the safety study is in compliance with these principles of good laboratory practice;
“raw data” means all original laboratory records and documentation, or verified copies thereof, which are the result of the original observations and activities in a safety study;
“reference substance” means any well defined substance or any mixture other than the test substance used to provide a basis for comparison with the test substance;
“regulatory authority” means any national authority with legal responsibility for aspects of the control of chemicals;
“safety study” means a non-clinical experiment or set of experiments—
(a) in which a substance is examined to evaluate its safety with respect to human health, animal health or the environment; and
(b) in relation to which a Community provision provides for the application of the principles of good laboratory practice in respect of that experiment or set of experiments;
“sample” means any quantity of a test or reference substance;
“specimen” means any material derived from a test system for examination, analysis, or storage;
“sponsor” means a person or entity who commissions or pays for a safety study;
“standard operating procedures” means written procedures which describe how to perform certain routine laboratory tests or activities normally not specified in detail in study plans or test guidelines;
“study director” means the individual responsible for the overall conduct of the safety study;
“study plan” means a document which defines the entire scope of the safety study;
“test substance” means a substance or a mixture which is under investigation;
“test system” means any animal, plant, microbial, cellular, sub-cellular, chemical, or physical system or a combination thereof used in a safety study;
“vehicle” means any agent which serves as a carrier used to mix, disperse, or solubilise the test or reference substance to facilitate the administration to the test system.
(2) In these Regulations, unless the context otherwise requires, a reference—
(a)
(a) to a numbered regulation or Schedule is to the regulation in or Schedule to these Regulations bearing that number;
(b)
(b) in a regulation to a numbered or lettered paragraph is to the paragraph of that regulation bearing that number or letter; and
(c)
(c) in a paragraph to a numbered or lettered sub-paragraph is to the sub-paragraph in that paragraph bearing that number or letter.
Functions of the Secretary of State
3. The Secretary of State—
(a) is designated as the authority within the United Kingdom responsible for—
(i) the verification of compliance with the principles of good laboratory practice within the United Kingdom,
(ii) the inspection of laboratories within the United Kingdom and the audit of studies carried out by laboratories to assess compliance with the principles of good laboratory practice, and
(iii) any other functions of the United Kingdom’s good laboratory practice monitoring authority arising out of or related to any Community obligation or the United Kingdom’s enjoyment of rights deriving from the Community’s cooperation with the OECD under or by virtue of the Treaties; and
(b) shall enforce compliance with these Regulations.
Requirement to be a member or a prospective member of the United Kingdom good laboratory practice compliance programme
4. A safety study shall not be conducted at any premises of a laboratory unless—
(a) the operator of the laboratory is regarded by virtue of regulation 5 or 6 as a member or a prospective member of the United Kingdom good laboratory practice compliance programme; and
(b) the operator’s membership or prospective membership of that programme is or is partly in respect of those premises,
and if a safety study is conducted at any premises of a laboratory in contravention of this regulation, the operator of that laboratory shall be guilty of an offence.
Prospective membership of the United Kingdom good laboratory practice compliance programme
5.—(1) An operator of a laboratory shall, for the purposes of these Regulations, be regarded as being a prospective member of the United Kingdom good laboratory practice compliance programme in respect of particular laboratory premises only if—
(a)
(a) he has informed the Secretary of State by notice in writing of the intention to conduct safety studies at those premises;
(b)
(b) the Secretary of State has in writing—
(i) acknowledged receipt of that notification, and
(ii) informed the operator that he is a prospective member of the programme in respect of those premises,
and he has not ceased to be regarded as a prospective member of the programme in respect of those premises by virtue of paragraph (2).
(2) Subject to paragraph (3), an operator of a laboratory shall cease to be regarded as a prospective member of the United Kingdom good laboratory practice compliance programme in respect of particular laboratory premises if—
(a)
(a) he is admitted to membership of the programme in respect of those premises by the Secretary of State;
(b)
(b) he informs the Secretary of State in writing that he no longer conducts or intends to conduct safety studies at those premises; or
(c)
(c) the Secretary of State informs him in writing that he is not prepared to admit him to membership of the programme in respect of those premises.
(3) The Secretary of State shall, before informing a prospective member of the United Kingdom good laboratory practice compliance programme under paragraph (2)(c) that he is not prepared to admit him to membership of the programme in respect of particular laboratory premises—
(a)
(a) inform the prospective member that he is considering taking such action and explain to him in writing the reasons why such action is being considered;
(b)
(b) give the operator a specified period within which to make representations to him; and
(c)
(c) consider any representations which are duly made and not withdrawn,
unless either there is a failure to adhere to the principles of good laboratory practice at those premises which, in the opinion of the Secretary of State, may contribute towards precipitating a danger to animal or human health or to the environment or in order to ensure fulfilment of any Community obligation, it is necessary for the Secretary of State to inform the prospective member immediately that he is not prepared to admit him to membership of the programme in respect of those premises.
Membership of the United Kingdom good laboratory practice compliance programme
6.—(1) Subject to paragraph (2) and except where paragraph (5) applies, the operator of a laboratory shall be regarded as being a member of the United Kingdom good laboratory practice compliance programme in respect of particular laboratory premises if—
(a)
(a) he is regarded by the Secretary of State...
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