CELEX: 51986PC0698
Language: en
Date: 1986-12-15
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE INSPECTION AND VERIFICATION OF THE ORGANIZATIONAL PROCESSES AND CONDITIONS UNDER WHICH LABORATORY STUDIES ARE PLANNED, PERFORMED, RECORDED AND REPORTED FOR THE NON-CLINICAL TESTING OF CHEMICALS ( GOOD LABORATORY PRACTICE )

17.1.87                                  Official Journal of the European Communities                               N o C 13/5
                                                                 II
                                                          (Preparatory Acts)
                                                   COMMISSION
                Proposal for a Council Directive on the inspection and verification of the organizational
                processes and conditions under which laboratory studies are planned, performed, recorded and
                           reported for the non-clinical testing of chemicals (good laboratory practice)
                                                        COM(86) 698 final
                               (Submitted by the Commission to the Council on 18 December 1986)
                                                            (87/C 13/06)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                              Whereas, however, in order to ensure that laboratories
                                                                      generating testing data in one Member State are also
                                                                      recognized by other Member States as working under
Having regard to the Treaty establishing the European                 GLP conditions it is necessary to provide for a
Economic Community, and in particular Article 100                     harmonized system of laboratory inspection and study
thereof,                                                              audit;
Having regard to the proposal from the Commission,                    Whereas it is necessary that Member States designate
                                                                      authorities for implementation of GLP monitoring;
Having regard          to the   opinion   of  the    European         Whereas a committee, the members of which will be
Parliament,                                                           appointed by the Member States, should help the
                                                                      Commission in the technical application of this Directive
                                                                      and cooperate in its efforts to encourage the free
Having regard to the opinion of the Economic and
                                                                      movement of goods by the mutual recognition by
Social Committee,
                                                                      Member States of procedures for control of compliance
                                                                      with GLP; whereas the committee set up by Council
                                                                      Directive 67/548/EEC of 27 June 1967 on the approx-
Whereas the application of standardized organizational
                                                                      imation of laws, regulations and administrative
processes and conditions under which laboratory studies
                                                                      provisions relating to the classification, packaging and
are planned, performed, recorded and reported for the
                                                                      labelling of dangerous substances (2), as last amended
non-clinical testing of chemicals for the protection of
                                                                      by        , may be used for this purpose;
man, animals and the environment, so called 'good
laboratory practice' (GLP), contributes to the reas-
surance of Member States as to the quality of the test                Whereas this   committee may assist the Commission not
data generated;                                                       only in the    application of this Directive but also in
                                                                      contributing    to the exchange of information and
                                                                      experience in  this field,
Whereas the Council of the Organization for Economic
Cooperation and Development has in its decision of 12
May 1981 on the mutual acceptance of data in the                      HAS ADOPTED THIS DIRECTIVE:
assessment of chemicals adopted, in its Annex 2,
principles of good laboratory practice which are accepted
within the Community, and are specified in Council                                               Article 1
Directive . . / . . ./EEC (');                                         1.   This Directive applies to the inspection and verifi-
                                                                      cation of the organizational processes and the conditions
                                                                      under which laboratory studies are planned, performed,
Whereas in the conduct of tests on chemicals, it is                   recorded and reported for the non-clinical testing for
desirable that resources in specialist manpower and in                regulatory purposes of chemicals (e.g. cosmetic,
testing laboratories must not be wasted by the need to                industrial, chemical, medicinal product, food additive,
duplicate tests owing to differences in laboratory                    animal feed additive, pesticide) in order to assess their
practices from one Member State to another;                           effect on man, animals and the environment.
0) COM(85) 380 final.                                                  O OJNo 196, 16. 8. 1967, p. 1.
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2.     For the purposes of this Directive, the organ-                                              Article 6
izational processes and conditions referred to in
paragraph 1 and hereinafter designated 'good laboratory                1.     The committee set up by Article 20 of Directive
practice* (GLP), are described by Directive . . / . . ./EEC.           67/548/EEC, hereinafter called 'the committee', may be
                                                                       consulted on the adaptation of this Directive to technical
                                                                       progress in accordance with the provisions laid down
3.     This Directive covers the verification and respect of           herein. Its chairman shall be a representative of the
the application of the principles of GLP and is not                    Commission.
concerned with the interpretation and evaluation of test
results or their acceptability.
                                                                       2.     Any question regarding the implementation of this
                                                                       Directive may be submitted to the committee at the
                          Article 2                                    request of its chairman or of a Member State, in
                                                                       particular on:
1.      Using the procedure specified in Article 3, Member
States shall verify the compliance with GLP of any
testing laboratory situated under its jurisdiction claiming            — cooperation between designated authorities of the
to use GLP in the conduct of tests on chemicals.                            Member       States    relating    to    technical    and
                                                                            administrative      matters      arising     from      the
                                                                            implementation of GLP,
2.      Where the provisions of paragraph 1 have been
complied with, the Member State in question may
endorse a claim by a testing laboratory in respect of a                — exchange of          information    on    the   training   of
specific test method using the form of words 'GLP certi-                    inspectors.
fication according to Directive . . / . . ./EEC on           '.
                                                                                                   Article 7
                          Article 3
                                                                       1.     Where a Member State has sufficient reason to
 1.     Member States shall establish or    designate the auth-        believe that a laboratory claiming GLP compliance has
orities responsible for the inspection       of laboratories on        not carried out a test according to GLP, it may request
their territories and for the audit of      studies carried out        further detailed information from the designated
by laboratories to ensure compliance        with the principles        authority in the Member State and in particular may
of GLP.                                                                request that a study audit, possibly in conjunction with a
                                                                       new inspection, be carried out.
2.      The authorities referred to in paragraph 1 shall
inspect the laboratory and audit the results of studies                Should it not be possible for the authorities concerned to
according to the provisions laid down in the Annex.                    reach agreement, they shall immediately inform the other
                                                                       Member States and the Commission thereof and give
                                                                       reasons for their decision.
                           Article 4
 1.     Each year, Member States shall draw up a report                2.     The Commission shall examine as soon as possible
relative to the implementation of GLP on their territory.              the grounds given by the Member States within the
                                                                       committee, and shall then deliver its opinion forthwith
This report shall contain in particular a list of labora-               and take the appropriate measures. It may in this
 tories inspected and a summary of the conclusions of the               connection ask experts from the designated authorities in
 inspections and of the study audits.                                  the Member States to give an opinion.
 2.     The report shall be transmitted to the Commission               3.     If the Commission considers that amendments to
 on request. The Commission shall communicate these                     this Directive are necessary in order to resolve the
 reports to the Committee referred to in Article 6.                     matters mentioned in paragraph 1, it shall initiate the
                                                                        procedure laid down in Article 9 with a view to adopting
                                                                        these amendments.
                           Article .5
  1.    Without prejudice to Article 8, the results of
 laboratory inspections and study audits on GLP                                                    Article 8
 compliance carried out by a Member State shall be
                                                                        The following shall be determined in accordance with
 binding on the other Member States.
                                                                        the procedure laid down in Article 9:
  2.     Where a Member State finds that a laboratory on
                                                                        — modification to the claim referred to in Article 2 (2),
  its territory claiming GLP compliance does not in fact
  comply with GLP it shall forthwith inform the
  Commission. The Commission shall inform the other                     — amendments necessary for adapting the Annex to
  Member States.                                                             technical progress.
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                                Article 9                                                                         Article 10
W h e r e the p r o c e d u r e laid d o w n in this Article is                    M e m b e r States shall bring into force the laws, r e g u -
invoked, the Commission shall decide after consulting                              lations o r administrative provisions necessary to comply
the committee. T h e c o m m i t t e e shall discuss matters on                   with this Directive n o t later t h a n 1 July 1988. T h e y shall
w h i c h the Commission has requested an opinion. W h e n                        forthwith inform the Commission thereof.
seeking the opinion of the c o m m i t t e e , the Commission
m a y set a time limit within w h i c h such opinion shall be
given. N o vote shall be taken. H o w e v e r , any m e m b e r of                                                A t' 1   n
the committee m a y d e m a n d t h a t his views be set d o w n in
the minutes.                                                                      This Directive is addressed to the M e m b e r States.
                                                                        ANNEX
                    PROGRAMME FOR T H E INSPECTION O F LABORATORIES A N D AUDIT OF STUDIES
               1. The inspection programme is concerned with the laboratory and the results of studies. The inspection
                  concerns the structures that have been used and the persons who are involved in the conduct of studies
                  in the laboratory. The inspection may address in a general and overall way many of the criteria that are
                  addressed specifically and in more detail in relation to the study audit. The inspection and the study
                  audit are not alternatives. They are complementary aspects of different degrees of examination of the
                  laboratory and its test results.
               2. An initial.assessment of a laboratory should comprise both an inspection and a study audit. Subsequent
                  inspections should be carried out every two to four years. The designated authority should determine
                  the frequency or necessity of study audits thereafter.
               3. In summary, the inspection programme should address all the criteria of 'good laboratory practice'
                  identified in the text describing such principles and verify the compliance of the laboratory with these
                  principles and should draw extensively on OECD provisions relating to these questions.
               4. The results of the inspection visit take the form of a written report which will cover all aspects of the
                  inspector's observations. The format of the report should parallel the sequence of items found in the
                  principles of 'good laboratory practice' contained in the OECD decision of 12 May 1981.
               A. Testing facility
                   (a) A control of the organization of the testing facilities, particularly:
                        1. a check of the qualifications of individuals that are designated 'study directors';
                        2. a check of the training programmes performed for the personnel involved in the studies;
                        3. a check, where possible, of the ratio between the studies performed and the available personnel.
                   (b) A control of the testing laboratory where the study or studies have been performed, particularly the
                        test substances storage area, animal rooms, environmental conditions and their monitoring systems.
               B. Standard operating procedures
                   (a) A control of the 'Standard Operating Procedures', with particular regard to the adequacy of the
                        procedures involved in the study, their modifications, if any, in the time and relative justifications.
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             (b) A control of apparatus employed in the study, particularly the records of the operations of
                 maintenance, standardization and calibration.
             (c) A control of the identification and storage conditions of reagents and materials.
             (d) A control of conditions of storage, maintenance and identification of the test systems used.
             (e) A control of the conditions of storage maintenance and identification of test substances and the
                  other substances, if and when used as reference standards (particularly important here are the data
                  relative to the purity, composition, stability of the pure substances and the data relative to the
                  stability of substance in the medium of administration).
          C. Quality assurance programme
             A control of internal Quality Assurance Unit (QAU) organization, such that it is possible to understand
             what are, or have been, the methods performed by QAU in the monitoring of the experimental work.
          D. Performance and reporting of the study
             (a) A control of adherence of final report of the study to the study protocol and/or to the
                  modifications, if any, and relative justifications.
             (b) A comparison of raw data (and the manner employed for their registration by the personnel and
                  study director) and data reported in the final report.
          E. Storage of records
             A control of all materials in the archives and the system of archivization.
          F. Completion of the inspection
             The inspection visit ends with a consultation between the inspector and representatives of the test
             facility on the inspectional observations.