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

2001-01-01 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 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 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 file (68 KB)

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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.

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