Food for Thought

The Biotechnology Quality Management System and Regulatory Compliance

Written by Goosmann Law Team | Aug 20, 2013 11:48:41 AM

August 20, 2013. The Biotechnology Quality Management System (“BQMS”) is a program designed to assist companies and organizations involved in biotechnology research and development, including small businesses and academic researchers. The goal of BQMS is to provide companies with the resources to evaluate the critical control points within their management systems to improve compliance with the Animal Plant Health Inspection Services (“APHIS”) regulations for the import, interstate movement, and field release of regulated genetically engineered (GE) organisms. Furthermore, the BQMS Program provides members of the regulated community with a better understanding of their regulatory responsibilities.

By voluntarily adopting a BQMS, businesses and organizations can improve the administration of regulated imports, interstate movements, and field releases by implementing document and record control, effective training, and continuous improvement. The primary consideration of BQMS is to facilitate a proactive approach to compliance with APHIS regulations.

For more information on how to implement a BQMS program within your business or organization, including information concerning the BQMS Program Audit Standards, visit the following link, BQMS Program.