8/9 December 2020
GMP News No. 904: ISPE Publishes New Guideline on Water and Steam Systems
ISPE Publishes New Guideline on Water and SteamSystems
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:
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.