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Process / Packaging Manufacturing Services
  • Process Monitoring
  • Streamlining and Simplification
  • Process and Packaging Related Investigations
  • Corrective Action and Preventive Action Plans (CAPA)
  • Process Capability Assessments
  • FMEA / Process Excellence
  • Six Sigma
  • Risk Assessment / Risk Analysis
  • Quality Engineering
  • Process Improvements
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  • Special Studies
  • Shipping Studies
  • Holding Studies
  • Procedures  Assessment and Upgrading
  • Equipment Trials
  • Statistical process Control Tools
  • Six Sigma/ Process Excellence Implementation
  • Raw Material Changes Qualification
  • New Suppliers Qualification
  • SOPs/Batch Records Review and Streamlining
  • Post Approval Changes: SUPAC and Guide to Packaging Changes (Changes to NDA / ANDA's)
  • Components Changes
  • Labeling Changes
  • Packaging Technologies
  • Good Manufacturing Practices:
    • 21 CFR Part 210, 211: Pharmaceutical Drugs
    • 21 CFR Part 820: Medical Devices
    • 21 CFR Part 809: Diagnostic Products
    • 21 CFR Part 600 - 680: Biologics
    • ICH Q7A : API's
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