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In March of 2013 in the EU the EMA introduced a new guideline related to Good Distribution Practices (GDP) and in June of 2013 the Chinese FDA introduced a new guideline related to Good Supply Practices (GSP).

If you study both of these regulations in some detail it will become very clear that these two new guidelines in structure and requirements are very similar and both clearly aimed at controlling human medicinal products from "Source to Patient".

Both have a requirement for a fully documented Quality Management Systems (QMS) and a fully documented Risk Assessment and Risk Aversion plan, which seems to be a step up requirement in many of the new, or updated regulations, and guidelines, now being introduced. Although this has been a requirement in the past it is becoming clearer that these two items are over-arching in all the other sections of the regulations.

I would be interested to hear from any of the Blog readers if they believe there is a renewed emphasize on Risk Mitigation planning?

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Peter Norton is a senior logistics and supply chain manager and consultant to the life science industry, with extensive experience in both the domestic US and global markets.

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