 |
 |
 |
 |
 |
 |
 |
Biotechnology Quality Management System (BQMS) Program |
|
 |
|
“I cannot imagine the Ag biotech regulatory compliance industry without this type of assistance/guidance program; it is the last piece of the puzzle.”
– Participant Testimonial
The Biotechnology Quality Management System (BQMS) Program helps organizations involved in biotechnology research and development, including small businesses and academic researchers, analyze the critical control points within their management systems to better maintain compliance with the APHIS regulations (7 CFR part 340) for the import, interstate movement, and field release of regulated genetically engineered (GE) organisms. In addition, the BQMS Program provides clarity and expectations of regulatory responsibilities to the regulated community.
Each participant’s BQMS focuses on effective planning of activities, checking the results of planned activities, and taking action with a goal towards continuous improvement. The operation of the BQMS is constantly self-verified and further validated through third-party audits.
The Office of Compliance Assistance provides participants with the tools and guidance needed to develop a BQMS that is tailored to their organization’s culture and needs. Compliance assistance is provided through:
- Interactive training workshops with other BQMS Program Participants and USDA officials,
- Documented guidelines and templates to aid in the development of a BQMS,
- A desk review,
- A baseline assessment of current management practices in relationship to the BQMS Program Audit Standard,
- One-on-one targeted assistance as needed,
- Internal audit training,
- Facilitated third-party audits of the organization’s BQMS, and
- Acknowledgement of BQMS Program completion and recognition.
BQMS Program Audit Standard v3.1
List of BQMS Participating Organizations
Participating in the BQMS Program |
|
|
|
Learn if your organization is qualified to participate in the BQMS Program, the advantages of voluntarily implementing a BQMS, and the cost of participating.
BQMS Participant Information |
|
|
|
Participants develop, implement, and maintain a BQMS within their organization to manage the movement and field release of regulated GE organisms. Specifically, organizations...
BQMS Program Operational Procedures |
|
|
|
The Office of Compliance Assistance follows documented procedures, to ensure consistent delivery of the BQMS Program. In addition, BQMS Program auditors utilize the BQMS Program audit checklists and guidelines to ensure consistent auditing practices.
|
|
|
|
