What you always wanted to know about Good Distribution Practices (GDP), but did not dare to ask.
On March 7th of this year, the European Union issued new guidelines on Good Distribution Practices (GDP) that will take effect in 6 months. An updated version of original guidelines from 1994 was released in 2011 for public consultation. The extensive input of numerous stakeholders led to the new publication focused on medicinal products for human use. Contents do not contain any surprises for professionals who followed developments at cold chain conferences in particular.
GDP documents are usually structured in a similar way, focusing more on quality management systems, procedures and documentation rather than technical details such as equipment and facilities. They address quality systems and risk management, responsibilities, records, training, self-inspections, complaints and corrective measures. The challenge today for integrators like FedEx is that there is no true, international GDP accepted standard. No ISO 9001 type certificates are available to demonstrate compliance. Many GDP versions appeared in the last couple of years around the world. They often used to be part of guidelines for Good Manufacturing Practices (GMP).
There are about 50 versions of GDP documents worldwide by now. While the focus used to be on cold chain management to reduce temperature excursions, the scope has now expanded to include issues related to security and counterfeiting. Countries, and also organizations and associations, are engaged in improving standards for proper storage, transportation and handling of healthcare products. In the US one often hears “USP <1079>” as standard of reference, in Canada “GUI-0069”, in the EU “2013/C 68/01” to name a few. The World Health Organization (WHO) with “TRS No. 957”, the International Air Transport Association (IATA) with “Chapter 17” and the Parenteral Drug Association (PDA) with “TR 52” have published guidelines that are more global in reach than those issued by countries or networks of countries. Sometimes pharmaceutical and biological products have their own separate guidelines such as in India. Often active pharmaceutical ingredients (APIs) are not in scope within general GDP and have to be treated elsewhere. GDP training courses are offered at conferences for participants to enhance their knowledge in that area and support GDP principles as a result. A grey zone around GDP is that documents do not differentiate clearly between transportation and distribution.
The two are very different in nature though. On one hand, transporters move shipments from origin to destination through a network, with contingency storage in case of unexpected events affecting the supply chain; transporters do not own the product, and they hold it only as long as necessary to get it delivered. Third-party logistics providers (3PLs) and wholesaler distributors, on the other hand, store products over a longer period of time in warehouses and need specialized licenses to operate; they are subject to strict regulations and inspections. In the FedEx portfolio, transportation and distribution fall in different operating companies: FedEx Express and FedEx SupplyChain, respectively. GDP guidelines are mainly applicable to distributors.
Since GDP are written in the spirit of guidelines rather than rules or laws, stakeholders might use this built-in flexibility to reach different conclusions and interpretations. FedEx professionals involved with healthcare regulatory matters engage in extensive internal discussions to agree on common standards and to ensure that relevant GDP content is properly addressed and applied.
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November 26, 2014
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