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.
Good Manufacturing Practices (GMP) Consulting
Types of Audits Supported
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.
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
USA
Brazil
Europe
Israel
UAE
India
China
Vietnam
Thailand
Taivan
Malaysia
Indonesia
Blogs
