Contamination and risk management

Published: 29-Apr-2014

As the pharmaceutical industry adopts new business structures and technologies to meet new economic demands, Alan Fisher, Dycem, reviews the impact of this change on contamination control and modern QC and QA procedures

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These are challenging times in the world of pharmaceutical manufacture. Of late, the industry has had to make vital decisions regarding its future, particularly with regard to outsourcing production and the introduction of new technologies. Trends such as outsourcing production to contract manufacturing organisations, the introduction of nanotechnology, rapid microbiological methods and the uncertainty of the ‘unknown’ means that life will be anything but quiet.

It was Donald Rumsfeld who said: ‘Reports that say something hasn’t happened are always interesting to me, because as we know there are known knowns; things we know we know. We also know there are known unknowns; that is to say, we know there are some things we do not know. But there are also unknown unknowns – the ones we don’t know we don’t know’. Contamination and cross contamination, complicated by the factors of contract manufacture, nanotechnology and new microbial test methods take us into a new era where the ‘unknown unknowns’ are waiting to be known.

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