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 inspect primary & secondary packaging material manufacturers and providers;


  • FDA Regulations and Guidances
  • European Union Directives
  • ISO 9001, 13485, 15378, PS 9000 Guidelines
  • EudraLex Guidelines
  • WHO Guidelines
  • MHRA Guidelines
  • PIC/S Guidelines

and others as required.;

A successful primary & secondary packaging material audit should be planned in a risk-oriented manner.

Before the start of primary & secondary packaging materials audit, we hold meetings with our customers and perform the following;


  • Possible risks and their manageability are assessed for primary & secondary packaging material supplier-manufacturer
  • A risk profile is submitted for primary & secondary packaging material 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 auditors needed are determined



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