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University of Nebraska–Lincoln

Biological Process Development Facility

cGMP Manufacturing

Quality Assurance Unit
cGMP Manufacturing

The Quality Assurance Unit (QAU) is the foundation for documentation of all development activities in the BPDF, successful technology transfer for commercial production, and cGMP production of Phase I/II clinical material. The QAU oversees the compliance to Good Manufacturing Practices (GMPs) by the Quality Control-Chemistry and Quality Control-Microbiology Laboratories and Pilot Plants. QAU also oversees Good Laboratory Practices (GLPs) compliance by the Fermentation Development Laboratory (FDL), Purification Development Laboratory (PDL), Molecular Biology Laboratory (MBL), Analytical Methods Laboratory (AML), and Protein Characterization Laboratory (PCL) of the BPDF.

Activities include:

  • Management of the documentation system including Standard Operating Procedures, GMP production batch records, raw material acquisition, and release oversight, and any necessary technology transfer documents.
  • Collaboration with BPDF staff, to generate the necessary documents to successfully transfer/produce the product.
  • Auditing of in house process development and production.
  • Identification and surveillance of outsourced services.
  • Oversight of calibration and maintenance of equipment, validation of major utility systems and their revalidation programs.
  • IQ, OQ and PQ of all new equipment related to GMP work.
  • Assistance to establish either a process that can be transferred into a GMP facility or production of GMP material for clinical trials.

The BPDF uses the Cerity Electronic Content Management (ECM) 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. Not only can machine readable instrument data files be stored, but also images, multimedia files, presentations, human readable word processing and Adobe PDF documents, spreadsheets, and hundreds of other formats. Using a web-based Virtual Personal Network (VPN), BPDF is able to allow clients to search for any records of interest regarding their project using an integrated Quick or Advanced query and view the files in the browser without the need for data generating applications for most file types.