supervision mainmenuitem

Recognizing the critical importance of integrated supply chain for our clients, we always prioritize it as the most important initiative, we use regulations from the following authorities for 3rd party storage & logistic service provider audits;

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

A successful 3rd party storage & logistic service provider audit should be planned in a risk-oriented manner.

Before 3rd party storage & logistic service provider audits, we hold meetings with our customers and perform the following;

  • Possible risks and their manageability are assessed in 3rd party storage & logistic service provider sites to be audited
  • A risk profile is issued for 3rd party storage & logistic service provider
  • Risk components are evaluated successively.
  • Components are classified and categorized
  • The number of audit days and inspectors needed are determined

Assessment reports are prepared and submitted.

The following items are reviewed for 3rd party storage & logistic service provider audits;

  • Location
  • Equipment
  • Staff
  • Information Technologies
  • Flexibility
  • Communication Skills
  • Qualification-Validation
  • Performance History
  • Quality Management Systems
  • Compliance with national and international regulations and guidelines
  • Pricing
  • And others as required.

 

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