Primary & Secondary Packaging Material

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