ISPE Publishes New Guideline on Water and Steam Systems

GMP News No. 904: ISPE Publishes New Guideline on Water and Steam Systems

GMP News
14 March 2007

ISPE Publishes New Guideline on Water and SteamSystems

Quite recently, the International Society for Pharmaceutical Engineering(ISPE) published the newGood Practice Guide Commissioning andQualification of Pharmaceutical Water and Steam Systems.

It is the aim of this guide to extend the principles laid downin the ISPE Baseline GuideCommissioning and Qualification to water and steam systems and to show thedirect influence of water and steam systems on pharmaceutical andbiotechnological applications. Here it is a new approach to identify theessential aspects of the validation life cycle based on the risk they involveand to confine oneself to these aspects during qualification. Parts of theequipment that are not relevant to qualification are commissioned aftermerely being documented.

The guide deals mainly with highly purified water, but it alsomentions water for injections and purified water. It gives details on projectand planning phase, procurement and construction, start-up and qualification aswell as monitoring and maintenance.

TheISPE Guide on Water and Steam Systems can be ordered via theInternet.

If your plant includes water systems, you can learn all the essentials ofthis subject at the GMP Conference Pharmaceutical WaterSystems - Key compliance issues to be held in Madrid, Spain,from 22-23 May 2007. This event has two parts:
"Pharmaceutical water systems and how to maintain a high quality level"and
"Rouging and how to avoid it".

The 4-day GMP Education Course PharmaceuticalEngineering taking place in Prague, Czech Republic, from 8-11May 2007 gives you comprehensive information about theregulatory and GMP requirements on equipment and facilities.

Dr Robert Eicher
On behalf of the European Compliance Academy (ECA)


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