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• Biopharmaceutical Quality Assurance

Biopharmaceutical Quality Assurance

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