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