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Good Manufacturing Practices (GMP) Consulting

Artixio's Global GMP experts are well experienced with ICH guidelines, EU GMP & GDP&GACP guidelines, WHO, ISO, US cGMP requirements and other international GMP regulations. They bring rich experience in GMP/GDP/GACP audits and international authority GMP inspections (EU,US, Mexico, Brazil, China, Japan, Russia & others) with more than 2000 executed audits as lead auditors of different products including APIs and FDFs; supply chain management etc.

Types of Audits Supported

  • Active Pharmaceutical Ingredients (API)
  • Contract Manufacturers (CMO)
  • Finished Drug Formulations (FDF)
  • Intermediates
  • Excipients
  • Packaging Material 
  • Laboratories
  • Medical Devices
  • Dietary Supplements
  • Supplier Audits
  • Pre-Inspection Audits
  • Remote & Onsite Audits
  • Quality Management System (QMS) Gap Analysis 
  • Regulatory Gap Analysis of GMP Documentation
  • Root Cause Analysis & CAPA
     

Countries Supported

India

China

Thailand

Indonesia

Malaysia

Taiwan

Vietnam

UAE

Israel

Brazil

Europe

USA

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