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BQMS Program Operational Procedures

The Office of Compliance Assistance provides compliance assistance to organizations involved in biotechnology research and development, including small businesses and academic researchers, to facilitate compliance with APHIS regulations (7 CFR part 340) for the import, interstate movement, and field release of regulated genetically engineered (GE) organisms. Compliance assistance is provided to the regulated community through a variety of mechanisms including education, template procedures and forms, the Biotechnology Quality Management System (BQMS) Program, and collaboration with academia and private and public stakeholders.

The Office of Compliance Assistance follows documented procedures to ensure consistent delivery of the BQMS Program.

1000 BQMS General Logistics Procedure

1000B BQMS Confidential Business Information Procedure

2000 BQMS Audit Process Procedure

5005 Quality Policy and Objectives

5070 Procedure, Appeals and Complaints

In addition, BQMS Program auditors utilize the BQMS Program audit checklists and guidelines to ensure consistent auditing practices.

BQMS Program: Baseline Checklist

BQMS Program: Process Audit Checklist

BQMS Program: Audit Guidelines

 

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Last Modified: July 8, 2013

 

 



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