OPULUS
Welcome Guest (Log in, Subscribe
 What's New | Home | About Us | Contact Us | Help Center | Publications | Site Map | Links | Subscription 


Last update:2012.04.04.
 Regulatory Basis  Forum Issues  Intelligence Services  Web Applications  21 CFR Part 11 Compliant Products 

Search: 
Regulatory Basis
Guides & Guidelines
Warning Letters
21 CFR Part 11 Issues


Adobe Acrobat Reader
Where are you now? Regulatory Basis > Guides & Guidelines > Water System Regulations

Water System Regulations

These files are in Adobe PDF format.
Click on the "Get Acrobat Reader" icon on the left of the page to
download a free copy of the Acrobat Reader.

sort by
Title
sort by
  Date  
 Download 

Guide to Inspections of High Purity Water Systems
This guide discusses, primarily from a microbiological aspect, the review and evaluation of high purity water systems that are used for the manufacture of drug products and drug substances. FDA

    PDF PDF file (68 KB) 

Note for Guidance on Quality of Water for Pharmaceutical Use
PDA Comments

 2001-01-01   PDF PDF file (38 KB) 

Note for Guidance on Quality of Water for Pharmaceutical Use
This document presents a discussion of the characteristics for consideration during the validation of analytical procedures included as part of applications submitted within the EC, Japan and USA. EMEA

 2001-01-01   PDF PDF file (137 KB) 

USEPA - METHOD 502.2 - 1995
Volatile Organic Compounds in Water by Purge and Trap Capillary Column Gas Chromatography with Photoionization and Electrolytic Conductivity Detectors in Series

 1995-01-01   PDF PDF file (208 KB) 

Click here if you have not found what you were searching for.

21 CFR Part 11 Issues
Various aspects of electronic records and electronic signatures
Forum Database
Almost 100,000 searchable messages from 16 working newsgroups. Updated regularly.
Warning Letters Knowledge Base
An extremely versatile database that will assist familiarization with the regulatory requirements
Competency Trainings & Exams
Multimedia enriched learning materials, exercises and exams.
On-line Trainings & Exams
Web-based learning materials, exercises and exams

back Back
----------------------------------
--| What's New | Home | About Us | Contact Us | Help Center | Publications | Site Map | Links | Subscription |--
© 2001-2003 OPULUS® is licensed to BioMondex Ltd. All rights reserved. Please read the disclaimer.