Regulatory Compliance

BioAgilytix aims to have one of the most comprehensive Quality Assurance (QA) programs in the industry. We have a distinguished regulatory track record with the USFDA and with our clients. All studies conducted at our facilities are of the highest quality, meet or exceed the criteria set forth by our Standard Operating Procedures (SOPs), and are performed in accordance with the requirements of the following regulatory agencies:

  • Organisation for Economic Co-operation and Development (OECD), Principles of Good Laboratory Practices (GLP) [ENV/MC/CHEM (98)17]

  • Japanese Ministry of Health, Labor and Welfare (MHLW), Good Laboratory Practice Standards (GLP Ordinance 21)

FDA Inspection for GLP-compliance

Our most recent inspection by the USFDA for overall compliance with GLP regulations was completed in March 2017.

Quality Assurance Unit

The BioAgilytix Quality Assurance Unit (QAU) maintains an independent organizational structure which has no direct connection to the laboratory departments that conduct research studies. This allows the QAU to effectively assess the conduct of all studies without bias. Although independent, the QAU works with the scientists and management team to continually improve BioAgilytix quality systems, processes, and procedures. In addition to routine internal audits/inspections, study audits/inspections, data audits, report reviews, and records management, the QAU makes recommendations for quality improvements based on quality system audits. BioAgilytix QAU participates in department meetings and updates the entire staff on quality systems trends and current regulatory compliance guidelines.

Each QAU member at BioAgilytix participates in a comprehensive training program involving hands-on training, as well as formal training in Good Laboratory Practices. The QA staff also attends external training seminars with topics on GLP compliance to broaden their knowledge base. All QA staff members maintain an active membership to the Society of Quality Assurance (SQA), the leading quality organization in the pharmaceutical industry.

"Internal quality system review audits are conducted annually to ensure that our Quality Assurance program is one of the most comprehensive in the industry."

Jose V. Buenviaje
Vice President
QA/Regulatory Compliance

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