Auditing/Batch Release

  • Review and approve Standard Operating Procedures, Master Production and Control Records, Batch Production Records, Master Specifications, and Certificates of Analysis.
  • Provide Product Lot Release.

GMP Documentation

  • Issue and control CGMP Documentation.
  • Manage records and documentation archives.

Engineering/Validation

  • Oversee calibration and validation of utilities and process equipment.
  • Oversee process validation work (e.g. aseptic media fills and cleaning validations).
  • Manage the Engineering Change Control system.

Training

  • Perform and evaluate CGMP training for BDP and other personnel.
  • Provide and manage an NCI-supported CGMP outreach training for other agencies, institutes and NCI collaborators.
  • BDP CGMP Training
Biopharmaceutical Quality Assurance