Entries by PharmOut

MHRA Annual GMP Symposium, 2012

On December 12 and 13, 2012, the MHRA held its annual GMP Symposium. I was able to attend this event and have captured some of the major themes within this blog.
December 12 – Good …

Cleanrooms in Simple Terms

What makes a cleanroom a clean room?
Like anything technical, how a cleanroom works is essentially basic, but wrapped up in a whole lot of jargon, standards, rules and regulations. The basic principles are actually …


Mr Clean, Inventor of the Cleanroom Passes Away

I have always said that Cleanroom Technology is not rocket science.  Although it seems the modern cleanroom was developed to assist with the progression of rocket technology.

Working out of Sandia National Laboratories, Willis Whitfield, …


The Real Value of a Cleanroom

Cleanrooms have been part of Life Science manufacturing for a long time, for example a device, pharmaceutical or a pharmacy clean room all have specific design requirements to make sure that they add value. …

Product Quality Reviews – The Right Approach

Quality Management Systems (QMS), be it ISO or PIC/S, mandate that system reviews must occur. Product Quality Reviews (PQR) can provide the ideal platform not solely to fulfill a compliance requirement but to give …