Quality standard

how to judge thatn pharma manufacturing company is maintaining standard at the time manufacturing drugs.
what are certifications to prove standard manufcturing in india as well as abroad

Following are the some indicators to ensure that a pharma manufacturing unit is maintaining high quality standards, if they have,

  • WHO GMP certification through GMP inspection
  • USFDA approval for their products (ANDA approvals & GMP inspection)
  • EU Regulatory authorities approval through GMP inspection
  • Drug Master File (DMF) registration with USFDA & inspection
  • Any other equivalent approvals or certification such as ISO 9001-2015 (Quality Management System- QMS)
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