The Quality Assurance Unit documents all development activities in the BPDF, successful technology transfer for commercial production, and cGMP production of Phase I/II clinical material.
The QAU oversees compliance with current Good Manufacturing Practices (cGMP) by the Quality Control-Chemistry and Quality Control-Microbiology Laboratories and Pilot Plants.
QAU also oversees Good Laboratory Practices (GLP) compliance by the Fermentation Development Laboratory, Purification Development Laboratory, Analytical Methods Laboratory, and Protein Characterization Laboratory.
The Quality Assurance Unit:
- Manages the documentation system including Standard Operating Procedures, GMP production batch records, raw material acquisition, and release oversight, and any necessary technology transfer documents.
- Collaborates with BPDF staff to generate the necessary documents to successfully transfer/produce the product.
- Audits in house process development and production.
- Identifies and conducts surveillance of outsourced services.
- Oversees the calibration and maintenance of equipment,
- Validates major utility systems and their revalidation programs.
- Qualifies the installation, operation and performance (IQ, OQ and PQ) of all new equipment related to GMP work.
- Assists in establishing a process that can either be transferred into a GMP facility or production of GMP material for clinical trials.
The BPDF uses the Cerity Electronic Content Management software from Agilent Technologies. This electronic data management system is used to collect, organize, warehouse, index, and safely archive all structured and unstructured electronic records from raw data and laboratory reports into compliance records, putting the information the BPDF needs to improve operations in one, convenient, easily accessible location.
The Cerity ECM software provides a secure, 21 CFR Part 11 compliant centralized electronic library for any and all electronic data files of any size. BPDF offers access to their clients to search for any documents related to their project.