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PostScription: Cleanroom Standards

Author(s):  Fitzpatrick Mike, Goldstein Ken

Issue:  Mar/Apr 2004 - Overview of USP Chapter <797>
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Abstract:  This brief article is a reprint of an article that originally appeared in CleanRooms magazine, a Penn Well publication. The authors look at the subject of standards, considering some of their strengths and weaknesses. On the plus side, they mention that standards provide fundamental information, a basis for moving in new directions, a means of formally reviewing projects to identify strengths and weaknesses, a common starting point and means of communicating, a way to save time and a means of simplifying and encouraging free trade. Disadvantages include the potential of becoming quickly outdated, the possibility of terminology’s remaining undefined if critical terms are too narrowly defined, the capability of being misused and the potential of delaying or stopping technological development. The authors conclude that it is necessary to choose and read standards carefully, use them appropriately and participate in groups to modify standards that need improvement.

Related Keywords: Cleanroom, standards for, Fitzpatrick, Mike, Goldstein, Ken, PhD, PostScription, cleanroom, standards for

Related Categories: BUSINESS, INFUSION, LEGAL, PARENTERALS, STERILE PREPARATIONS, SUPPORT, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS

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