GDP

 

Good Distribution Practices

Based on EU regulation 92/25/EEG guidnace for good distribution practices, wholesales organisations for pharmaceutical products should implement a a system to assure the integrity of the pharmaceutical products throughout the supply chain.

In order to achieve this, requirements are included in the guidance (94/C63103) whcih focus on::

  • General elements
  • Personnel
  • Documentation
  • Orders
  • Procedures
  • Protocols
  • Premises and equipment
  • Receipt
  • Storage
  • Delivery to customers
  • Returned products
  • Emergency response and recall
  • Counterfeit medical products
  • Self inspections
  • etc..

We provide consultancy services and training on GDP iisues. We can combine our services with management system approaches based on the SQAS distributor (food, Pharma & cosmetics module).