OCNS GLP requirements
Good Laboratory Practice
The OECD Good Laboratory Practice (GLP) guidelines embody a set
of principles that provide a framework within which laboratory
studies are conducted. GLP concerns all aspects of a laboratory
study from initial planning of the work to archiving of the study
data. The purpose of GLP is to help assure regulatory authorities
that the data submitted are a true reflection of the results
obtained during the study and therefore may be relied upon when
identifying hazards and assessing risk.
The OECD principles of GLP were first published by the OECD in
1982 and subsequently revised in 1997. These principles were
adopted by the European Community (EC) and published in the
appendix to Directive 2004/10/EC. As a result of this directive EC
member states must incorporate into their national laws the
requirement for all non-clinical safety studies, which are listed
in sectoral directives, to be conducted to GLP, and that the
premises conducting such studies must be regularly inspected by a
national authority.
In the UK the GLP regulations are laid down in Statutory
Instrument No. 3106, The Good Laboratory Practise Regulations,
1999. Compliance is administered by the GLP monitoring authority,
which is part of the Medicines and HealthCare Products Regulatory
Agency (MHRA).
In the Netherlands the GLP regulations are laid down in Wet op
milieugevaarlijke stoffen. Compliance is administered by the
Voedsel en Waren Autoriteit (Food and Consumer Products Safety
Authority), part of the Ministry of Agriculture, Nature and Food
quality
Companies commissioning tests (the sponsor) and testing
laboratories are reminded that:
Each test chemical (and reference substance) should be
appropriately identified and defined (e.g. Lot or Batch number,
chemical abstracts service registry number (CAS number), chemical
name, purity, concentration). In cases where the sponsor supplies
the test chemical, there should be a mechanism to verify the
identity of the chemical tested in the study. It should be apparent
from the final report that the identity of the test substance has
been confirmed.
When commissioning tests to be submitted to Cefas for the
purposes of the OCNS, the sponsor should ensure that the study plan
clearly states not only the relevant OECD (test) guideline for the
test to be conducted but also the endpoints that it is expected
will be taken from this study to complete the relevant section of
the HOCNF. As the final report must include all of the information
specified in the study plan this approach will ensure that the
final report is suitable for the purposes of the OCNS. It is the
supplier's responsibility to ensure that studies they specify on
the HOCNF allow them to complete all the mandatory fields.
When a report is requested by Cefas only a copy of the final
report will be accepted. This report will include the signatures of
the study director and quality assurance personnel on appropriate
GLP compliance and GLP quality assurance statements,
respectively.
For further information on GLP please follow the following
links
OECD web site
http://www.oecd.org/home/0,2987,en_2649_201185_1_1_1_1_1,00.html
European commission GLP web site
http://ec.europa.eu/enterprise/chemicals/legislation/glp/index_en.htm
UK Medicines and HealthCare Products Regulatory Agency
(MHRA)
http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=5
British Association of Research Quality Assurance
(BARQA)
http://www.barqa.com
Netherlands Government Organisations and
Legislation
http://www.overheid.nl
Voedsel en Waren Autoriteit
http://www.vwa.nl/zoekresultaten?zoekterm=glp