Good Distribution Practice Audits
All stakeholders in the supply chain of medicinal products need to comply with GDP requirements in accordance with the European Guideline since September 2013.
Manufacturers of medicinal products are in charge to check that the products will be distributed under controlled conditions, that`s why, wholesalers, transport companies, warehouses and other partners in the supply chain will have to be selected thoroughly.
We suggest auditing all organizations involved in the distribution channel.
- Analysis of cold chain and transportation risk assessment
- Analysis of the current GDP status of a company
- Consulting on elimination of discrepancies
- Qualification of temperature-controlled storage areas
- Сomputerized system validation for Enterprise Resource Planning (ERP) systems