WHY SterRx

PRODUCT TESTING AND FACILITY MONITORING

Every aspect of SterRx manufacturing sets an unsurpassed standard for quality and sterility that allows us to consistently deliver what you care about most— patient safety. To produce sterile preparations of the highest quality, SterRx follows FDA requirements for 503B compounding, including:

Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
Current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals—21 CFR Part 211
Guidance for Industry—Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practices
cGMP/503BMeetsDetails
Incoming Material Control
  • Materials quarantined until tested/examined and released by quality unit
  • Full testing until supplier’s results are validated
Vendor Qualification/API Testing
  • Product-specific: filter validation and bioburden
Production Controls
  • Fully automated production; no manual intervention with BFS processes
  • Detailed batch records completed in real time
  • Fully qualified water system
  • In-process inspections and testing
  • Hold times established
  • Control of microbiological contamination
  • Comprehensive manufacturing investigation system
Packaging/Labeling Controls
  • Line cleaning and clearance
  • Strict label controls
  • Product inspection
Training
  • Ongoing cGMP training of staff, with verification and assessments
Laboratory Controls
  • Equipment qualified
  • Product specific: sterility and test method validation
  • Reserve samples
  • Comprehensive laboratory investigations
Environmental Monitoring
  • Monitored surface and air quality
  • Personnel gowning qualification
  • Rigorous cleaning regimen with rotation of cleaning agents
  • Static and dynamic monitoring
Stability Program
  • Real-time stability monitoring
  • Accelerated studies, where appropriate
Validation Program
  • Media fills performed for each process to ensure proper aseptic technique
Other Quality Systems
  • Customer complaints documented and investigated by QA
  • Corrective action/preventive action (CAPA)
  • Customer complaints
  • Annual product reviews (APRs)
  • Internal audits
Document Control
  • Standard operating procedures/forms/methods
  • Rigorous documentation practices