The BPDF has separate chemistry and microbiology GMP Quality Control laboratories operated by trained and experienced QC professionals. The labs conduct in-process, product release and stability testing using general USP and EP test methods, as well as methods customized to specific products. Testing is performed using qualified instrumentation, operating procedures and test methods. Test results and reports are reviewed and approved by Quality Control and Quality Assurance.
The Quality Control group performs monthly microbiological and particulate monitoring of the GMP facility, following validated environmental and facility monitoring programs. The monthly data is used to track and trend activities within the facility to ensure GMP production areas meet cleanliness and ISO cleanroom classification requirements.