Tuesday the 7th October 2014
Martin Lush underlines the importance of controlling plant shutdowns so that start-up is on time with minimal disruption to the ongoing supply of products.
“We all have our war stories of shutdowns dragging on for weeks, not days, and it is worrying that after many engineering intervention...
Tuesday the 10th June 2014
The visual appearance of sterile drug products is obviously a key quality attribute for any formulated product, yet the pharma industry still struggles to define, control and set in place effective monitors. Freedom from particulates has been a compendial requirement for three decades so why is ... Read more
Wednesday the 12th March 2014
Make sure this hot topic doesn’t burn you … or your suppliers, contract manufacturers or contract laboratories
How confident are you that there are no data integrity issues within your firm, or within the many suppliers, contract laboratories or contract manufacturers you use in the developmen... Read more
Tuesday the 3rd December 2013
This brief article outlines the new EU requirement for a “Qualified Person” (QP) which is contained in the EU Regulation due to replace the current medical devices Directives 93/42/EEC and 90/385/EEC. The new Regulation has been the subject of fierce debate between the various stakeholders throu... Read more
Friday the 8th November 2013
Europe has introduced further measures for unannounced audits of manufacturers by notified bodies. With this in mind, James Pink, VP Europe-Health Sciences Medical Devices at NSF International, provides a little help to prepare for them.
There are two important documents that are ... Read more