Good Distribution Practice: Brief Overview

“In theory, there is no difference between theory and practice. In practice there is.” – Yogi Berra

Good distribution practice, also known as GDP, was originated by the World Health Organisation (WHO) and the European Economic Community. It was written as a set of guidelines for the pharmaceutical suppliers. Today these guidelines are issued by various regulatory bodies.

Who is responsible for GDP and why is it important?

The marketing authorisation holder is responsible for GDP which is useful for prevent and guarding against risks that can cause dire consequences through standards of practice.

The WHO describes GDP as “ensuring the quality and integrity of pharmaceutical products during all aspects of the distribution process” and the “establishment, development, maintenance and control over activities involved”.

GDP is important for traceability and verification which prevents:

  • – Falsification of drug identity and origin
  • – Tampering with medicinal products
  • – Diversion from chain of supply
  • – Infiltration from illegitimate third parties
  • – Substitution of medicinal products

Who is affected by GDP?

A list of life science companies that are obliged to comply with GDP are:

  • – Manufacturers and processors
  • – Logistics providers
  • – Transportation providers
  • – Importation and exportation service providers
  • – Suppliers of components
  • – Wholesalers distributors
  • – Pharmacies

Conclusion

Good business relationships between parties in distribution, storage and movement of goods should be maintained. Everyone’s duties and responsibilities are critical for GDP as well as documentation and verification in order to have a seamless process.

Author: KVALITO Consulting Group

To obtain the full-text article, please e-mail us: contact@kvalito.ch

 

 

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