Regulatory Compliance

GLP Compliance

At BRI, the Quality Assurance Unit is an integral part of our operation in every study. Study Directors, scientists and the QAU all shared a common value in providing the highest level of uncomprised data quality in every study. From sample shipment inventory to automated Therm-Watson? LIMS data reduction and reporting, we have successfully performed and delivered hundreds of bioanalytical and DM/PK studies under GLP.

BRI follows the following Good Laboratory Practice Regulations/ Standards/ Guidelines, including:

– United States Food and Drug Administration, Title 21 Code of Federal Regulations Part 58, Current
– Organization for Economic Cooperation and Development, The OECD Principles of Good Laboratory Practice, Series on Principles of Good Laboratory Practice and Compliance Monitoring, Monograph No.1 to 14, current
– Japanese Ministry of Health and Welfare, Ordinance No. 21, April 1, 1997

GLP Practices and Standards

BRI Biopharmaceutical Research Inc. is licensed under the following regulated activities:

– GMP / GLP Establishment License by Health Canada for supporting manufacturing QC testing of API and drug products
– CNSC Nuclear Substance License by the Canadian Nuclear Safety Commission for the use of 14C and 3H isotopes
– CCAC accredited by the Canadian Council on Animal Care for use of laboratory animals
– AAALAC accredited by the Association for Assessment and Accreditation of Laboratory Animal
Care International for use of laboratory animals

Canadian Council on Animal Care

– Controlled-drug licenses for a variety of controlled and scheduled drug substances
– CFIA Animal Pathogen Import Permit
– Health Canada Human Pathogen Importation Permit

aaalac