Transport Validation GDP: Case Examples

How does the customer benefit?

Compliance with the new EU Good Distribution Practice (GDP) guideline, transport validation and qualification along with an improvement of the overall transportation processes are achieved with affordable effort despite time pressure and very complex situations. 

Case 1:

In the wake of the new EU-guideline for GDP, a leading, global pharmaceutical company decided to develop a transport validation concept for one of their large production sites, which sent around 8’000 transports per year to the entire world. The complexity of the task and the consequent potentially huge workload and cost of a possible suboptimal solution was the major obstacle to the development of an own concept for the company. MVLSC developed the required concept within the given time and cost frame and laid out the concept in a detailed Master Validation Plan for Lane Qualification and Validation. The customer recognized the concept as very straight forward, robust and simple as well as satisfying all necessary GDP requirements. Consequently the customer rolled out the concept in their company world-wide per a global guideline.

Case 2:

A global big pharma company planned to roll out an innovative medicine into numerous countries world-wide. The task was to validate the transport of the medicine into each country prospectively before the launch in that country. The natural complexity of the task was aggravated through the uncertainty and time pressure, because not all countries, dosage forms, or transport categories were exactly known yet at that point in time, and the transport validation /qualification subproject was perceived as a small part of the big world-wide launch project that itself was under time pressure. In this situation the responsible team of the company did not feel confident to resolve the issue in time, to the required quality and with an effective concept. MVLSC developed the required concept in tight collaboration with the customer team and laid it down in a detailed Master Validation Plan for Lane Qualification and Validation. The company applied the concept and the transport qualification/validation subproject was a great success within the successful world-wide product launch project.

Case 3:

As consequence of the new EU GDP-guideline a leading global pharmaceutical company decided to qualify/validate all their transports from all their European sites to the entire world. Given the numerous products, transport categories, sending and receiving sites world-wide, around 20’000 transports per year with all possible transport modes, this resulted in a very complex matrix with millions of options. Under these circumstances the experts of the company were not confident to find feasible and practicable solution. MVLSC developed a concept with templates for all necessary documents and lead a 2 years project with the customer site teams, in which all lanes of the company world-wide were qualified or validated, the quality of the transportation processes improved and a continuous transport process verification and improvement process installed.