Quality Control Laboratory

Integrity Bio partners with clients to help them bring safe, effective, and FDA-compliant products to the clinic. GMP Testing is conducted according to strict scientific protocols, performed accurately, and completed on time. The Quality Control (QC) laboratory is fully equipped with state-of-the-art instrumentation.

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Quality Control

Integrity Bio’s quality control laboratory provides:

  • All environmental monitoring programs required of GMP clean rooms and process utilities
  • Analytical testing in support of PD activities
  • Finished product testing
  • Stability¬†program¬†management and testing

Testing Services

Product specific method development, transfer, qualification, and validation USP methods on validated equipment:

  • HPLC/UPLC
  • CE
  • UV or protein concentration
  • Sterility
  • Bioburden
  • Stability
  • Moisture Analysis
  • Endotoxin by Limulus
  • Amebocyte Lysate
  • Total Organic Carbon
  • pH & Conductivity
  • Surface¬†Monitoring

GMP and nonGMP capabilities

  • Expiry
  • Batch to batch comparability
  • The selection of alternative excipient vendors
  • Manufacturing condition changes
  • Performance of delivery devices
  • Preparation of backup formulations
  • Clinical needs and requirements
  • Drug interactions
  • Container closure systems
  • Excursions from recommended handling conditions