Oecd guidelines glp
[DOC File]Microsoft Word - GLP Inspection Checklist.doc
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GMP (Good Manufacturing Practices) Qualification. Utilize the list below in qualifying each vendor. A Vendor is a person, organization, company, or institution …
[DOCX File]WordPress.com
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It was followed a few years later by the Organisation for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD has since helped promulgate GLP to many countries. GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the ...
[DOCX File]ARGOM: Appendix 4 - Guidelines on OTC application for new ...
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Information on the regulatory status of the new substance in other countries should be provided. If an application for approval has been rejected or withdrawn prior to approval, or withdrawn (e.g. due to adverse effects) following marketing approval, this should be noted in the application.
[DOCX File]1
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(GLP) - is a quality system that deals with the organisational process and conditions, under which laboratory studies are planned, performed, monitored, recorded and reported (Organization for Economic Co-operation and Development (OECD) GLP Guideline). GLP practices are intended to promote the quality and validity of test data.
[DOC File]OECD.org - OECD
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much information as possible on the planned study in order to support the evaluation of the proposal. Typically, this would include at least the test guideline, information on the test material, the species and the route of administration in the corresponding distinct fields, as appropriate.Consult any programme-specific guidance (e.g. OECD Programme, Pesticides NAFTA or EU REACH) on whether ...
[DOC File]D80 assessment report - Non-Clinical template with ...
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Study type Test protocol Results Remarks Adsorption-Desorption OECD 106 or … Koc = List all values Ready Biodegradability Test OECD 301 Aerobic and Anaerobic Transformation in Aquatic Sediment systems OECD 308 DT50, water = ... Any deviations from the toxicology programme as stated in the guidelines or from GLP or any absence of required ...
[DOCX File]United States Environmental Protection Agency | US EPA
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EPA OCSPP Harmonized Test Guideline 860.1340 Residue Analytical Method (August 1996) PMRA Regulatory Directive DIR98-02 – Residue Chemistry Guidelines, Section 3 – Residue Analytical MethodEU SANCO 825/00/rev. 7 (17/3/04)
[DOC File]OECD.org - OECD
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OECD Test Guidelines are harmonized test methods included in the OECD Council Decision on Mutual Acceptance of Data. This means that “data generated in the testing of chemicals in an OECD Member country (or some non member economies) in accordance with OECD Test Guidelines and OECD principles of Good Laboratory Practice
QUESTIONNAIRE ON IMPLEMENTATION OF THE 1989 …
GLP Doc 7.0 . Template of 22 February 2013. QUESTIONNAIRE ON IMPLEMENTATION OF THE 1989 COUNCIL ACT ON COMPLIANCE WITH GLP - C(89)87(FiNAL) [The text in blue can be used by Member States in order to fill in the annual OECD questionnaire]
[DOC File]Microsoft Word - INHALATION SS NEWSLETTER Summer 06.doc
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This means that data generated in a member country in accordance with OECD Test Guidelines and Principles of Good Laboratory Practice (GLP) shall be accepted in other Member countries for assessment purposes and other uses related to the protection of human health and the environment. Some of these guidelines are already in use.
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