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/
