Good Manufacturing Practice Services

  • American & Canadian drug Good Manufacturing Practice audits
     
  • Quality Systems
     
  • Pre-approval inspections
     
  • Good Laboratory Practice reviews
     
  • Vendor audits
     
  • FDA medical device Quality System Regulation audits
     
  • Training in GMP & QSR
     
  • Advice on chemistry and microbiology laboratory practices and method validation
     
  • Advice on manufacturing systems including purified & water for injection systems
     
  • Advice on sterile product manufacturing and quality control
     
  • Development of process and method validation protocols
     
  • Functioning as the qualified Person in Charge of the quality control department

 

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