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What’s this whole QA? - Part 2

Posted Oct 23 2008 1:43pm

Happy New Year,

Life and work have been very busy since my last post in October. As a result, blogging has taken a decidedly backseat. And so it goes.

At this point, I’d like to pick it back up though and continue where we left off. Quality Assurance in the Pharmaceutical (and related) Industries. Now, if one looks up the subject of Quality Assurance on Wikipedia (an online resource that I highly recommend, by the way), we get the industry independent, generic, vanilla description of what QA is:

Quality assurance, or QA for short, is the activity of providing evidence needed to establish quality in work, and that activities that require good quality are being performed effectively. All those planned or systematic actions necessary to provide enough confidence that a product or service will satisfy the given requirements for quality….

Now, that’s not a bad start. It does cover some of the key concepts with regard to manufacturing, particularly in industries other than Pharma. However, it does little to address the particular nuances of what quality is in terms of Pharma Manufacturing and Pharma Research.

Previously, I talked a bit about the whole point of QA being related to Safety and Data Integrity. The Pharmaceutical Industry is among the most regulated in the world (particularly in the US). In fact, it is often stated that Pharma is more regulated than Nuclear Engergy. Now, I don’t know whether that is definitively true, but I think just being in that ballpark gives us some context for my next points:

1) People expect more from their medicines. *That* is why they are so regulated.
2) QA has a unique role in the Pharmaceutical and related industries. This is a core reason for this Blog to further explore what this means.

I’m going to continue writing on this topic, but in bite-sized posts rather than longer, more polished essays. We may get to the essays eventually, but I think it is more important to get some of this stuff down.

~TJK

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