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Water System Regulations

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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) 

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) 

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21 CFR Part 11 Issues
Various aspects of electronic records and electronic signatures
Forum Database
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Warning Letters Knowledge Base
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