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Joint Order No. 455/2006 of the Ministry of Economy and Trade, the Ministry of Public Health and the Ministry of Agriculture, Forests and Rural Development validating the Procedure regarding the inspections of the test installations and the verification of the studies in order to comply with the principles of good laboratory practice.

Country/Territory
Romania
Document type
Regulation
Date
2006
Source
FAO, FAOLEX
Subject
General
Keyword
Inspection Enforcement/compliance Data collection/reporting Access-to-information
Geographical area
Black Sea, Eastern Europe, Europe, Europe and Central Asia, European Union Countries
Abstract

This Join Order establishes the Procedure regarding the inspections of the test installations and the verification of the studies in order to comply with the principles of good laboratory practice. Inspections of test installations shall provide data on the safety of health and the environment, which are necessary for regulatory purposes. Inspectors may be required to verify data on the physical, chemical, toxicological or ecotoxicological properties of a substance. Inspectors must take a uniform approach to assess whether an appropriate level of compliance with each of the GLP principles is achieved in the case of a specific test facility or study. The procedures for inspection of test facilities and studies shall include: I. preliminary inspection, II. Organizational preparation of the inspection III. conducting the inspection. Items subject to inspection: (a) inspection of the organization and personnel of the test facility; (b) inspection of the quality assurance program; (c). inspection of installations; (d) inspection of care, accommodation and isolation of biological testing systems; (e) inspection of apparatus, materials, reagents and samples; (f) inspection of test systems; (g) inspection of test and reference substances; (h) inspection of standard operating procedures; (i) inspection of the study; (j) inspection of final reports; (k) inspection of storage and preservation of documents and materials; (l) inspection regarding the verification of studies; and (m) completion of inspection of test facilities and study verifications.

Full text
Romanian
Website
legislatie.just.ro