EC introduces Quality Risk Management into revised Guideline on Good Distribution; ISPE helps Members prepare

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The European Commission (EC) published a revised Guideline on Good Distribution Practice (GDP) on 7 March 2013. The effective date for its implementation is 8 September 2013. 

The new guideline - which can be downloaded here - revises one that had been in place for nineteen years and introduces a number of new requirements. It is the first time that the European Medicines Agency (EMA) has introduced Quality Risk Management to GDP. There also is greater emphasis on computer validation and expanded focus on quality systems.

What will the changes mean?

There is an expectation that inspections will place a much greater emphasis on risk mitigation in line with the Quality Risk Management approach.

How can I learn more?

ISPE provides an unparalleled opportunity to hear directly from the Medicines and Healthcare Products Regulatory Agency (MHRA) at the ISPE World Class Supply Chain Conference to be held in Prague in June.  During the regulatory panel discussion, Senior GDP Inspector Tony Orme will highlight the changes to the new GDP Guideline and potential changes to inspection, and he will be available to discuss implications of the changes with attendees during the conference.

Some of the other new areas in the Guideline:

  • the maintenance of a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
  • suitable documentation which prevents errors from spoken communication;
  • sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
  • adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
  • appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
  • outsourced activities correctly defined to avoid misunderstandings;
  • rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport;
  • specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products).

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