Frequently Asked Question

What is EU GMP and how do I get certified?

EU Good Manufacturing Practice (GMP) is the EU standard for pharmaceutical manufacturing. Indian API and finished dose manufacturers must have EU GMP certification to sell to EU pharmaceutical companies or patients. Process: (1) implement EU GMP (Annex 1-16) in your facility, (2) an EU national competent authority (MHRA, ANSM, BfArM, etc.) or EMA conducts an inspection, (3) if compliant, a GMP certificate is issued, valid 3 years. PHARMEXCIL coordinates EU GMP audit preparation for Indian pharma companies.