Monday, April 9, 2012

Pre-use/Post-sterilization integrity testing - the use of a debate for commercial purposes !

Why, one has to ask, is it that a scientific, biopharmaceutical industry topics ends up to become ones again a commercial opportunity to some ?!
Is it not bad enough for the industry to convince regulators that a) processes and activities used for decades in the industry work reliably and b) one knows what one does, i.e. leave the decisions to the end-user ? No, instead of supporting the industry with expertise and a one voice approach, scientific and/or regulatory topics become a contest by the supply industry ! The "who knows best" game is played and unscientific debates spur the fire of confusion. Moreover in instances like this, the regulatory confusion is even used as a commercialization opportunity. Purely to gain a few percentage points of increased revenue an entire industry is subjected to non-common sense regulatory demands.
When do suppliers realize that not the supplier with the highest commercial sense, but the one with the most scientific sense and support will be embraced by an industry which is scrutinized enough ?
A prime example is the current debate of the necessity of pre-use/post-sterilization integrity testing. The topic is fairly easy to resolve; leave the decision whether or not such integrity test should be performed or not to the end-user, to the industry. They perform the riosk assessment and not the supplier, they require to justify their activities to regulators and not the supplier and they have the best experience with their processes and not the supplier. The supplier should support with data, when asked for and required. This topic is not about the ability to perform such test and the great engineering abilities of suppliers, it is about the choice of the industry to either perform such test or not and what are the risks involved.
However, as usual, some suppliers think to take advantage out of a situation like this, express their unsolicited opinion and cause more problem for the industry than good.
Time to stop this nonsense and rather put science in front of commerical motivations !

No comments:

Post a Comment