Quality Assurance

The BPDF Quality Assurance (QA) group oversees the Quality System and verifies compliance with each of the major processes with audit and investigation activities. The group’s change management and document control processes ensure that all Quality System documentation meets current GMP requirements. Quality System documentation includes the Quality Manual, Standard Operating Procedures, Work Instructions, Forms, Batch Records, Specifications, Test Methods, Maintenance/Calibration Records and Training Assessments.

The QA group collaborates with BPDF production and Quality Control (QC) staff to generate technology transfer and method development documentation, oversees process and product qualification/validation protocols and reports, and develops the design and content of client manufacturing records. The QA group ensures that GMP activities meet client expectations by assessing the quality of incoming materials, monitoring manufacturing processes, and reviewing all production-related documentation prior to product release.