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:
Balancing Pre- and Post-Market Control of Health Supplements
Tuesday, 06 Dec 2016 13.12
Biopharmaceutical Manufacturing Process Validation and Quality Risk Management
Monday, 05 Dec 2016 17.12
Know Before You Go: 2016 ISPE Biopharmaceutical Manufacturing Conference
Friday, 02 Dec 2016 17.12