By recognizing what integrated supply chain means for our customers and always prioritizing it as the most important initiative, we use the guidelines and regulations from the following authorities in order to audit Active Pharmaceutical Ingredient (API) manufacturers and providers;
- ICH Guidelines (EU, Japan, US)
- FDA Regulations, Guidelines
- European Union Directives
- EudraLex Guidelines
- WHO Guidelines
- MHRA Guidelines
- PIC/S Guidelines
- and others.
A successful API audit should be planned with a risk-assessment objective.
Prior to the API audits, we hold meetings with our customers and perform the following tasks;
- Possible risks and their manageability are assessed for API supplier-manufacturer
- A risk profile is provided for API 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 are determined
- An assessment report is prepared and submitted.