Good Distribution Practice Update: Industry Insight

Pharma Logistics IQ speaks to Tony Wright, CEO of Exelsius Cold Chain Management for his expert insight on Good Distribution Practices to find out the latest updates and forecasts for the industry.

1. What are the biggest GDP challenges for pharma companies?

   For most pharma companies(and perhaps those particularly operating under the regulatory guidance of the EU), a key challenge is the ability to create and maintain an innovative and competitive distribution channel strategy. For many, this has involved an internal downstream change whereby the logistics/distribution/purchasing functions have clearly begun to play a greater role in the company’s overall supply chain management. Whilst QA remain a vital part of the distribution strategy, there has clearly been a shift towards a more overall cost-effective process. 

   In addition, the need for continued visibility of the supply chain and which seems increasingly to involve improving relationships with logistics  and distribution suppliers, is playing a greater role.

   All of this is of course against a regulatory background that has placed much more GDP compliance in the hands of pharma manufacturers. Balancing the need for that compliance, whether it is for finished products or API, whilst remaining competitive, remains a real challenge.

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2. How can these be addressed?

   There is no doubt that pharma companies need to continue to fully understand their supply chain and its component parts. No longer is it practical or sensible to ‘only’ understand the basic shipping and distribution cost. Based upon the principles of Route Qualification And Risk Management (both of Which are Key features of The EU GDP guidance EU343/01) it is necessary to break down the total cost of each process stage in order to create a ‘Total Cost of Ownership’ profile. This allows a better comparison of, for example, packaging components, storage and handling of those components and the time/manpower costs involved when using different types of transport solutions.

    

   Since there has been a shift in Logistics process ‘ownership’, It is also essential to accurately and regularly measure and monitor the performance of any outsourced suppliers. Many companies will of course be familiar with the principles of establishing Key Performance Indicators (KPI’s). I believe that there are a few key aspects that are not sufficiently well implemented when establishing KPIs: 

   • Measure the few, not the many:  Don't overcomplicate the process of measurement with unnecessary KPIfs . 
   • What gets measured gets fixed.  If it can't be measured its likely to remain a problem unsolved . 
   • Share. Create KPIfs as part of a partnership for continuous improvement. Remember that performance measurement is a two-way process.

   Other topics in this discussion include:

   “The first step is to acknowledge the problem, and then you can move on to risk management and analysis”

   

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   • The potential  consequences of the challenges faced. 
   • Regulation updates.
   • GDP Continuous Improvement.

Download the interview in full below.