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More than 700 questions with reference to regulations.

 

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The New USP <1231>
Water for Pharmaceutical Purposes

a detailed Overview

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GMP LOGFILE Features

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

 
2016-07-20

Roadmap to Manage Personnel in Pharmaceutical Manufacturing

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Michael Hiob

 
2016-07-12

What typical situations must be controlled by a quality management system?

An excerpt from GMP Fundamentals

by Dr. Christine Oechslein

 
2016-07-06

Basic Principles of a Document Management System (DMS)

Excerpt from the GMP Series pdf download
Successful Implementation of Electronic Document Management Systems


by Markus Roemer

 
2016-06-29

Change Control – Dealing with Changes in Investigational Medicinal Products

by Kerstin Kruithoff-Ley

 
2016-06-22

System types by extent of automation

Excerpt from the GMP Series pdf download Electronic Batch Recording for Drugmakers


by Markus Roemer

 
2016-06-15

Overview of the New USP <1231>
Water for Pharmaceutical Purposes

by Fritz Röder

 
2016-06-01

Qualification of Single-Use Component:
The Need for Standardization

by Christopher Smalley

 
2016-05-25

Quality Metrics – Bane or Boon?

GMP Talk with Experts Claudia Pachl and Ruven Brandes

by Dr. Sabine Paris

 
2016-05-13

Microbiological monitoring of cleanrooms – regulatory requirements

Excerpt from the GMP Series pdf download Monitoring of HVAC Systems in GMP Environments

by Dr. Hans H. Schicht

 
 
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