Pharma Consulting


Core Experience in:
  • Designing & qualification of formulation manufacturing facilities
  • Manufacturing operations of wide spectrum for formulations
  • GMP compliance and regulatory audits.
Core Competency:
  • Designing and Operations of:
    • Isolator based manufacturing facility for Cytotoxic / high potency injectable formulations, including Lyophilized formulations.
    • Manufacturing facility for Aseptic or terminally sterilized Injectable formulations
    • Manufacturing facility for Oral Solid dosage forms – Tablets and capsules
    • Manufacturing facility for External Preparations (Ointments and Creams)
  • Upgradation of existing facilities for GMP compliance and productivity improvements
  • Designing of formulation manufacturing facilities
  • Preparation of URS for manufacturing facility and equipment
  • Preparation of Qualification documents: IQ/OQ/PQ
  • Equipment and facility qualification
  • Clean Room qualification and designing facility monitoring program
  • Developing equipment cleaning processes and Cleaning Validation
  • Risk Assessment and risk mitigation
  • GMP Training
  • Facility Audit and gap identification.
  • GMP compliance
  • Deviation investigation and root cause identification