inglasiasupporting global quality in the
manufacture and distribution of medicine

Regulatory Inspection Preparation

  • Covers GMP and GDP inspections
  • Support companies in obtaining EU GMP certification
  • Specialise in preparation for MHRA (Medicines and Health Regulatory Authority) inspections
    • We create and follow through checklists for inspection readiness
    • Provide general staff training on MHRA inspection requirements
    • Creating a list of stationery and electronic systems required for the inspection
    • Setting up electronic systems to support ’back room’ and ’front room’ communications
    • Conduct audit rehearsals – for lead and support functions
  • Conduct Pharmaceutical GMP and GDP Gap analysis audits
  • Conduct Risk assessments
  • Perform Quality Control checks on documents to be reviewed at the Regulatory Authority inspection
  • Prepare and review Standard Operating Procedures
  • Organisation of the ’back room’ for MHRA inspections – preparation for efficient retrieval of documents
  • Organisation of ‘front room’ Q&A sessions
  • Perform mock inspections

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