Do you know your most critical GDP risk?

If you started to think before answering this question, I might think that you do not have much data about the importance of risk management in GDP, let alone the criticality of your risks. It is possible to summarize quality risk management as a preventive practice that should be included in every step of GDP activities, just like GMP and GLP operations.

The most well-known and implemented quality risk management tool in the pharmaceutical and biotechnology industries is ICH Q9. Since its first publication in 2005, it was not renewed until the last two or three years, but it came into force on January 18 last year.

We all accept that there are risks inherent in the storage and distribution of medicines. Considering that not only the drug product itself but also components such as API and Excipient reach the customer in a distribution chain, it should not be unreasonable to talk about a GDP concept starting from the raw material.

As you all remember, one of the most important API disasters in history occurred in 2008 with the API product called “Heparin”. After this date, of course, the dangers associated with many APIs, Excipients and finished products continue. When you look at the root cause of such incidents, you will see that many of sources are not registered, not approved and not audited from a GMP and GDP perspective.

GDP is a process that directly affects public health. Even the slightest disruption in the distribution process can lead to serious delays and the infiltration of counterfeit drugs into the supply chain. Of course, GDP does not end at this point; the issue of traceability of medicines is also an issue that should be on our agenda together with GDP.

GDP will actually directly or indirectly affect every aspect of transportation, storage and distribution. During the transportation of pharmaceutical, biotechnology and API products, risks should be classified by taking into account all kinds of shock and vibration, as well as temperature and humidity. Therefore, temperature and humidity stand out as two critical parameters in the journey until it reaches the end user.


  • How and where we position the temperature and humidity monitoring equipment?
  • If we are using computerized systems, how should we validate them?
  • Why will we need to qualify suppliers and customers?
  • What training should the responsible person receive and what should his/her university degree be?
  • What should we understand about the health and hygiene of the personnel?
  • How should we establish a solid quality management system?
  • How should we manage temperature and humidity deviations?
  • How often and in what situations should we repeat the temperature mapping study?
  • What are the differences between active and passive transportation methods?
  • Should we accept that transportation is a mobile storage?
  • Which records and how in what time?
  • How we should store our data, how we should ensure the integrity of our data?
  • How and with whom we should carry out internal audits for the continuity of our GDP system? 

It is now possible to find answers to dozens of questions at a single address where you simply register for one of the most demanded training courses…





Published on May 20, 2024 by Angela Spall