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University of Nebraska–Lincoln

UNL

Biological Process Development Facility

Quality Assurance (QA)

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 recently installed Cerity Electronic Content Management (ECM) System, an electronic data management system 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. Cerity ECM provides a secure, 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. Cerity ECM automatically extracts searchable metadata from each of the files using ECM SmartFilters. Using a Web-based Virtual Personal Network (VPN), one is able to search any records of interest 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.