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More than 650 typical questions related to audits and inspections.

 

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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

>>> ORDER NOW

GMP LOGFILE Features

2017-09-20

Technology Transfer Phases

An excerpt from GMP Series A Successful Concept for Technology Transfer in Drug Manufacturing

5 minutes reading time

by Christian Gausepohl, PhD

 
2017-09-13

Data Integrity – Old Wine in New Skins?
GMP Talk Between the GMP Inspector Dr. Petra Rempe and Thomas Peither – Part 2

Data Integrity – Old Wine in New Skins?

GMP Talk Between the GMP Inspector Dr. Petra Rempe and Thomas Peither – Part 2

7 minutes reading time

by Sabine Paris, PhD

 
2017-09-06

Data Integrity – Old Wine in New Skins?

GMP-Talk Between GMP Inspector Dr. Petra Rempe and Thomas Peither – Part 1

7 minutes reading time

by Sabine Paris, PhD

 
2017-08-30

Human Resource Management: Qualification requirements and requirement profiles

An Excerpt from the GMP Series PDF Download Roadmap to Manage Personnel in Pharmaceutical Manufacturing

by Michael Hiob, PhD

 
2017-08-23

GMP-Compliance-Index 2017

Join in now and further your knowledge!

by Thomas Peither

 
2017-08-02

What you can expect from the newly amended MRA between the EU and the USA – Facts and figures in the GMP Sector – Part 2

5 minutes reading time

by Sabine Paris, PhD

 
2017-07-26

What you can expect from the newly amended MRA between the EU and the USA – Facts and figures in the GMP Sector – Part 1

5 minutes reading time

by Sabine Paris, PhD

 
2017-07-19

Checklist Performance Qualification

An Excerpt from the GMP Series PDF Download The Ultimate Checklist for Premises and HVAC Qualification

by Hans H. Schicht, PhD

 
2017-07-12

Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

A report on the ISPE 2017 Europe Annual Conference

6 minutes reading time

by Sabine Paris, PhD

 
2017-07-05

Types of Biotechnological Active Substances

An excerpt from GMP Series Managing GMP Requirements in Biotech API Manufacturing

by Dr. Rainer Gnibl

 
2017-06-28

Manufacturing Innovation -
PDA Annual Meeting 2017, Anaheim

8 min. reading time

by Thomas Peither

 
2017-06-21

Test results outside defined criteria (OOX)

An excerpt of the GMP Series Download Industry Guide to handle OOX Test Results

by Dr. Markus Limberger

 
2017-06-14

Changes in USP <1231>: Water for Pharmaceutical Purposes

8 min. reading time

by Fritz Röder

 
2017-06-07

Independent and Linked CAPA Systems

An excerpt from the GMP Series How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment

3 min. reading time

by Dr. Bernd Renger

 
2017-05-31

Quality Agreement – A Sample Document

An excerpt from the GMP Series Quality Agreement

by Dr. Christine Oechslein

 
 
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