inglasiasupporting global quality in the
manufacture and distribution of medicine

Qualified Person and Quality Expert Services

Our QPs and Quality Experts can provide the following services, in accordance with Pharmaceutical Good Manufacturing Practice (GMP) requirements:

  • Product release for solid dose tablets, capsules, granules, liquids and creams
  • Quality Risk Management
  • Equipment Qualification
  • Process Validation
  • Cleaning Validation
  • Computer Systems Validations
  • Environmental Monitoring
  • Product Quality Review
  • Quality Incidents Investigation
  • Customer Complaint Investigation
  • Root Cause Analysis
  • CAPA
  • Host for regulatory and customer audits
  • Internal audits
  • External Audits for APIs, dosage form, components and distributors
  • Technology Transfer
  • Analytical method development/validation
  • Utilities: Purified water, HVAC
  • Change Control
  • GMP and vocational training
  • Technical Agreements
  • Batch certification
  • Site Master File
  • Provide consultants to be named as Qualified Person on Manufacturers/Importers Authorisation as person releasing medicinal product in the EU.

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