Quality Assurance

Assessment of Good Manufacturing Practices (GMP) Compliance, Quality Management System, and Risk Management Capabilities

  • Mock Inspections to identify risk Areas
  • In-depth dssessment of manufacturing processes, quality assurance operations
  • Computerized manufacturing, analytical, record-keeping systems
  • Review and assessment of documentation and standard operation procedures

Assistance in Inspection Readines

  • Document submission readiness
  • Pre-Approval inspection readiness
  • Compliance inspection Readiness

Assessment of Supply Chain Fitness and Compliance

  • Inspection of Quality Management Systems
  • Assessment of GMP compliance
  • Assessment of supply chain suitability and risk
  • Writing of SOP's, specifications & drawings, work instructions, protocols, reports.
  • Equipment installation, calibration and validation.
  • Suppliers audits and approval
  • Master batch record
  • Master Formulation Records
  • Manufacturing instructions
  • Packaging instructions
  • Component specifications (API, excipient, container and closure System)
  • Bulk & Finished Product Specifications
  • Commercial stability protocol
  • Manufacturing change authorization summaries
  • Equipment
  • Facilities
  • Suppliers


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