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More than 700 questions with reference to regulations.

 

4. The New USP <1231>: Water for Pharmaceutical Purposes
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The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

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GMP LOGFILE Features

2016-12-07

Rework: What has to be observed?

An excerpt from the GMP MANUAL

by Dr. Christian Gausepohl

 
2016-11-29

Managing Contract Manufacturers and Testing Labs

An excerpt from the GMP Focus download Managing Contract Manufacturers and Testing Labs

by Dr. Christian Gausepohl, Dr. Frank Böttcher

 
2016-11-22

Line Clearance

An excerpt from the GMP Series download GMP Compliance Basics of Packaging Materials and Processes

by Ruven Brandes, Dr. Christian Gausepohl

 
2016-11-16

Transport Validation

An excerpt from the GMP Focus download Creating a Master Plan for Drug Warehousing, Transportation and Distribution

by Dr. Christoph Frick, Dr. Nicola Spiggelkötter

 
2016-11-09

The qualification life cycle concept and tools: an overview

An excerpt from the GMP MANUAL

by Ulrike Reuter

 
2016-10-20

Validation Planning

An excerpt from the GMP Focus download Managing Process Validation: A Drugmaker's Guide

by Dr. Christine Oechslein

 
2016-10-12

Evolution and a Touch of GMP Revolution at the PDA/FDA JRC 2016

(Reading time 5 min + 3 min video)

by Thomas Peither

 
2016-10-05

Self-Inspection

An excerpt from the GMP Focus PDF Download Preparing for the EU GMP Inspection

by Dr. Christian Gausepohl and Max Lazar

 
2016-09-28

Not yet all clear: Draft EMA Q&A paper on production of WFI by non-distillation methods

An interview with Fritz Röder

 
2016-09-21

Receiving the OOS result and starting the OOS process

An Excerpt from the GMP Series PDF Download Industry Guide to handle OOX Test Results

by Dr. Markus Limberger

 
2016-09-14

The changing concept of validation

An excerpt from the GMP MANUAL

by Dr. Christine Oechslein

 
2016-09-07

Achieving “Quality beyond Compliance” is a Matter of Leadership

by Thomas Peither

 

 
2016-08-31

Sanitisation

Exclusive Excerpt from the new pdf download The New USP <1231>: Water for Pharmaceutical Purposes


by Fritz Röder

 
2016-08-23

Separate Device Specification for the FDA?
Your question - our answer

by Thomas Peither

 
2016-08-03

Don’t Be a Daredevil When Retrofitting Your Facility

by Bob Ferer

 
 
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