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Pharmaceutical Quality

Quality

Quality is the backbone of our business. Our Quality Management System maintains strict documentation records for our products including batch records, retain samples, and label generation and control.  Combined with full lot traceability and validated manufacturing production processes, our quality system will ensure our products meet your production requirements and demands.

Quality Management Systems include:

  • Full Lot Traceability
  • Change Control Management
  • GMP Document Control
  • Label Generation, Control,  and Reconciliation
  • Environmentally Monitored Production Processes
  • Environmentally Controlled Production Facilities and Warehouses
  • Non-Animal Origin (BSE/TSE) Control
  • Corrective Action/Preventative Action (CAPA) Systems
  • Raw Materials Audit Program
  • Validated Manufacturing and Production Processes
  • Quality Monitored Production Processes
  • In-House Audit Program
  • Personnel Training Programs

Analytical and testing programs include both standard and customized testing via internal laboratories or qualified external laboratories.  Capabilities include the following:

  • Compendial Testing
  • Endotoxin Testing
  • Bio-burden Testing
  • Sterility Testing
  • ICP Mass Spec
  • FTIR
  • HPLC, GC, LC-MS
  • Titrations
  • Materials Testing Retain Program
  • In-Process and Product Release Testing