By recognizing what integrated supply chain means for our customers and always prioritizing it as the most important initiative. In order to audit finished product manufacturers we use the guidelines from the following regulatory authorities;

 

  • Republic of Turkey Ministry of Health, Turkish Medicines and Medical Devices Agency
  • Republic of Turkey Ministry of Food, Agriculture and Livestock
  • FDA Regulations, Guidelines
  • European Union Directives
  • EudraLex Guidelines
  • WHO Guidelines
  • MHRA Guidelines
  • PIC/S Guidelines

and others as required

 

A successful finished product manufacturer audit should be planned in a risk-oriented manner.

Before the audit of the finished product manufacturer, we hold meetings with our customers and perform the following analyses and assessments;

 

  • Possible risks and their manageability are assessed for finished product manufacturer
  • A risk profile is issued for finished product 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 auditors required are determined
  • An assessment report is prepared and submitted

 

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