WCI's Marty Boom analyses the increasing impact of non-GMP regulations on pharmaceutical manufacturing

New laws focused on pharmacovigilance and safety, such as Volume 9A of the EUs legislation on pharmaceuticals, affect manufacturing more than most people realise.  For example, it defines the Qualified Person for Pharmacovigilance (QPPV) role in a manner similar to the Qualified Person role in manufacturing.  In practice, this drives overlap between these roles, especially when it comes to process oversight.  But it is not all bad news.  Volume 9A also offers new opportunities for the manufacturing group to be more involved at an early stage of product development.  Patient Safety Risk Management (SRM) opens the door for closer collaboration between manufacturing and development.  Where Chemistry and Manufacturing Controls (CMC) often fail, SRM might just work. 

To read the article in full please click on the pdf link below:

Pharmacovigilance - Friend or Foe?

Or read PMPS magazine at: PMPS Magazine Spring Issue 2010 the article can be found on pages 62 - 63.

About PMPS
Pharmaceutical Manufacturing and Packaging Sourcer magazine is published by Samedan Pharmaceutical Publishers Ltd on a quartely basis in February, May, August, and November. The specialist journal has been designed to provide worldwide coverage of a range of topics relating to the pharmaceutical manufacturing and packaging sector. It provides a platform of communication and information sharing for executive and strategic decision makers within the industry; identifying new trends, marketing opportunities, as well as highlighting the latest innovations in the dynamic environment.

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Pharmaceutical Manufacturing and Packaging Sourcer