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Operating a Stringent Quality & Regulatory Program

  • Upholding Global Regulatory Requirements
  • Testing to the Highest Quality Standards
  • Applying Rigorous Oversight & Controls
Highlights Include:
  • Global GMP Standards Meeting US-FDA, ICH Q7 & IPEC Guidelines
  • Comprehensive Internal Auditing of all Manufacturing Processes
  • Regulatory Services including Drug Master File Submissions
  • FDA Process Validation for all GMP Manufacturing Systems
  • Complete Testing of all Finished Manufactured Lots
  • On-site Quality Control Labs Operating 24/7
  • Robust Preventive Maintenance Program
  • State-of-the-art Instrumentation
  • FDA Registered & Inspected
  • Raw Materials:
    • Qualifi ed and Inspected Sources
    • 100% Authentic Traceability
    • Complete Testing
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Quality Assurance
  • Validation of all GMP Manufacturing Systems
  • Rigorous Preventive Maintenance Program
  • Qualifi cation of all Equipment
  • Stringent Cleaning Protocols
  • Environmental Monitoring
  • Change Control Process
  • Equipment IQ-OQ-PQ
  • Document Control
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Regulatory Control & Support
  • Creation and Submission of Drug Master Files for APIs and Excipients
  • Creation and Control of all Critical Documentation
  • Management of all External Audits and Certifi cations
Quality Control
  • Fully staffed, on-site Quality Control Laboratories
  • Validation and Verifi cation of all Test Methods
  • Qualifi cation of all Instrumentation including ICP-MS, GC-MS, HPLC, UV/Vis, TOC, Ion Chromatographer, Conductivity Meter, Microcount UATR, Polarimeter, Karl-Fisher Titrator & more
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