Guidelines for Quality in Pharma Logistics
As a patient, you want to be certain that the quality of your medication remains unchanged throughout the chain of supply. How can you be sure that the pills that arrive at your hospital, your physician or pharmacist are identical to those shipped by the manufacturer? As an organization that is part of this chain of supply, you can ensure this by complying with the EU Guidelines for Good Distribution Practice of medicinal products for human use. Its focus: distribution, security, temperature control, packaging quality and reliable, functional technology.
Compliance with the GDP requirements is recognized proof of a company having successfully established the relevant controls in the supply chain; it is therefore able to deliver safe products of high quality in accordance with the requirements of pharmaceutical manufacturers. Implementing these requirements and having their effectiveness confirmed by an independent third party makes you a reliable business partner within the health care sector’s chain of supply. By consistently applying the Guidelines, and by responsibly handling medicinal products for human use, you set a competitive advantage, and you contribute to enhancing patient safety.
GDP requires a well implemented and effective quality management system. Building on that, organizations can implement the specific requirements of the GDP Guideline with little effort.
EU Guideline* on Quality in Pharma Logistics
There are many requirements for pharmaceutical products even after assembling and packaging. Medicinal products and excipients are usually distributed over long distances and through different climate zones, and are stored in various warehouses – overall, the distribution network is constantly getting more complex. In addition, the awareness of compliance with good storage, transport and distribution practices is growing globally. The EU Guideline on Good Distribution Practice (GDP) tightens the requirements for transport and logistics service providers. It also addresses pharmacies and wholesalers, as well as logistics providers operating in procurement, stock receipt, storage, shipping and transport.
*For companies operating exclusively outside the EU, DQS also offers certification according to the Word Health Organization’s (WHO) Good Distribution Practices for Pharmaceutical Products”.
Benefits of GDP Pharma certification
Significantly fewer individual customer audits
Higher degree of transparency and reliability in the supply chain
Noticeably fewer damages and loss
Increased legal certainty and improved reputation
Possibly lower insurance premiums due to recognition by insurers