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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

2017-03-29

Document Access for GMP Inspectors and Auditors of Notified Bodies

Your question – our answer – Part 2

(5 min. reading time)

by Dr. Sabine Paris

 
2017-03-22

24 GMP documents You Should Know About–

A Concise Review of Everything New in 2016

by Sabine Rabus

 
2017-03-15

What do GMP compliance and GEP mean?

An excerpt from the GMP Compliance Adviser

(4 min. reading time)

by Thomas Peither

 
2017-03-08

Temperature monitoring and control

An excerpt from the GMP Series The Process of Freeze-Drying

(3 min. reading time)

by Dr. Margit Gieseler

 
2017-03-01

Self-Inspection Q&A

(4 min. reading time)

by Dr. Doris Borchert and Dr. Sabine Paris

 
2017-02-22

Executing Sterile Filtration

An excerpt from the GMP Series download Aseptic Processing of Sterile Medicinal Products

by Ruven Brandes

 
2017-02-15

How do you create awareness for GMP compliance in a ­company?

An excerpt from the GMP MANUAL, Chapter 18.I.4.1

(3 min. reading time)

by Thomas Peither

 
2017-02-08

Sampling Frequencies

An excerpt from the GMP Series download Microbiological Monitoring in Pharmaceutical Manufacturing

by Dr. Hanfried Seyfarth

 
2017-02-02

Managing Outsourced GMP Activities Successfully

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Dr. Frank Böttcher and Dr. jur. Ingo Schneider

 
2017-01-25

Limit Values for Cleaning Processes:
Implementing Toxicological Risk Assessment – Part 2

(5 min. reading time)

by Dr. Sabine Paris

 
2017-01-18

Limit Values for Cleaning Processes:
Implementing Toxicological Risk Assessment – Part 1

(5 min. reading time)

by Dr. Sabine Paris

 

 
2017-01-11

Alert and action levels and specifications

An excerpt from the USP <1231> Download

by Fritz Röder

 
2016-12-14

Quality Metrics – What will the FDA require in the future? How are companies already benefitting today?

(5 min. reading time)

by Dr. Sabine Paris

 
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

 
 
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