GDP
Introduction
Good Distribution Practice guidelines (94/C 63/03) were originally published in 1994 to ensure quality throughout the supply chain. The guidance referenced the need for a Quality Management System commensurate with the activities of Wholesale and distribution.
In order to account for other legislative changes (such as to prevent the entry of falsified medicines into the supply chain) together with the natural advancement of practices in this area; a new guidance is out for review.
Some points of interest:
- Responsible Person qualifications have been further defined
- Formal reference to temperature mapping
- ‘The required storage conditions for medicinal products should be maintained during transport…’ in the context of the EMA concept paper on storage conditions during transport, what does this mean for your company? How will you adapt your QMS to manage this?
- Incorporation of the definition of a ‘Broker’
To open the the Commission Guidelines on Good Distribution Practice of Medicinal Products for Human use (consultation) click HERE
How do you comment?
Simply add comments in the comment field of this page or email me on advocacy@pqg.org
Please make it clear which part of the text you are referring to (i.e. chapter heading) and provide as much information as possible to add maximum value.
When should you comment by?
I will collate all comments and respond on behalf of the PQG members by the deadline for the consultation. With this in mind, can you provide all comments by the 23rd December 2011
Thanks!
4 Responses to “GDP”
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2.3 An RP need not be a person qualified in Pharmacy but should be well versed with the quality risks associated with distribution and should be able to make a learned decision from experiences of quality, pharmaceutics and regulatory requirements.
Chapter 2 makes no mention that a RP’s decision on the fate of a product received or to be distributed should not be influenced by anyone regardless of position in the company, financial gain/loss or KPI. Honesty is paramount and being an RP is a privilege. No MD or CEO should be able to manipulate a RP into making a call against their will or being ignored and overruled.
Thanks to all that commented on this important paper! The response has been submitted and both the PQG consolidated output and the commission’s response will be posted in the new year.
I feel so much happier now I understand all this. Thanks!
This is a strategic function and will the existing contract be relevant in the future if the business model changes? If the supplier is no longer required an accurate assessment of the repercussions needs to be carried both from a financial and operational perspective.