By recognizing what integrated supply chain means for our customers and always prioritizing it as the most important initiative, we use the following aspects and regulations in order to audit excipient manufacturers and providers;

 

  • FDA Regulations, Guidelines
  • European Union Directives
  • Excipact Guidelines
  • EudraLex Guidelines
  • WHO Guidelines
  • MHRA Guidelines
  • PIC/S Guidelines
  • and others as required

 

A successful excipient audit should be planned with a risk-assessment objective.

Before starting excipient audit, we hold meetings with our customers and perform the following analyses/assessments;

 

  • Possible risks and their manageability are assessed for excipient supplier-manufacturer
  • A risk profile is provided for excipient supplier-manufacturer
  • Risk components are evaluated successively.
  • Components are classified and categorized
  • Parameters such as manufacturing, technology, capacity, etc. are reviewed.
  • The number of audit days and inspectors required are determined
  • An assessment report is prepared and submitted

 

 

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