The Enterey Blog

4 Rules to Facility Start-up. The Final Rule of Facility Start-up.

Posted by Tita Tavares on Thu, Aug 25, 2011 @ 02:40 PM

We’ve reached our final rule for facility start-ups:

The law of “The Jungle”

This rule is a play on two literary references that are applicable to a Life Sciences facility start-up.  The first is a reference to the book The Jungle by Upton Sinclair.   This book, published in 1905, exposed unsanitary conditions in the Chicago meat packing industry and served as a catalyst for the Pure Food and Drug Act passed in 1906.  This act is a pre-cursor to today’s current good manufacturing practices (cGMPs) that govern Life Sciences companies.  These cGMPs are non-negotiable and must be followed regardless of impact to the schedule of the start-up.  I know for most this goes without saying, but it is worth driving home the point.  Yes cGMPs are guidelines, and yes most companies go above and beyond cGMPs but in the thick of some of the financial pressures that occur during a highly visible capital projects like a facility start-up these sometimes can and do get forgotten. 

I realize in rule #3 we stressed not placing invisible boundaries to problem solving, cGMPs are very real boundaries and should always be followed.

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The second literary reference is to the last line of Rudyard Kipling’s poem The Law of the Jungle which is as follows


“…For the strength of the Pack is the Wolf, and the strength of the Wolf is the Pack.”


This one line summarizes the type of teamwork that is required through a successful start-up.  There is no one individual or functional area that is more important than another.  All groups / individuals play their part and need to work together to both solve problems and drive towards success.   There will be problems, there will be delays but a start-up team will always succeed if they focus on the appropriate level of detail, are balanced in their approach, don’t create artificial boundaries, all while adhering to cGMPs and working as a TRUE team.

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Published by Carlo Odicino | Former Director, Client Services


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Next week’s blog:
Laboratory Information Management System (LIMS) toward Streamlined Biotechnology and Pharmaceutical Operations



Tags: Facility Start-up, Life Sciences, cGMPs, Law of the Jungle, Final Rule to Facility Start-up