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 Steam Systems

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

It is the aim of this guide to extend the principles laid down in the ISPE Baseline Guide Commissioning and Qualification to water and steam systems and to show the direct influence of water and steam systems on pharmaceutical and biotechnological applications. Here it is a new approach to identify the essential aspects of the validation life cycle based on the risk they involve and to confine oneself to these aspects during qualification. Parts of the equipment that are not relevant to qualification are commissioned after merely being documented.

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

The ISPE Guide on Water and Steam Systems can be ordered via the Internet.
  

If your plant includes water systems, you can learn all the essentials of this subject at the GMP Conference Pharmaceutical Water Systems - 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 Pharmaceutical Engineering taking place in Prague, Czech Republic, from 8-11 May 2007 gives you comprehensive information about the regulatory and GMP requirements on equipment and facilities.

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

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK