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GMP LOGFILE: Lead Article

LOGFILE No. 21/2013 - Transport of Medicinal Products

05.05.2014

By Dr. Christoph Frick and Dr. Nicola Spiggelkötter

 

LOGFILE No. 20/2013 - Change Control

25.04.2014

Author: Dr. Michael Hiob

 

LOGFILE No. 18/2013 - Audit Procedures

22.04.2014

Authors: Dr. Michael Hiob, Max Lazar

LOGFILE No. 17/2013 - Process Validation

14.04.2014

Process Validation

PDA Technical Report No. 60 as a practical guideline

By Thomas Peither

 

LOGFILE No. 15/2013 - Drugmakers and Contractors

08.04.2014

Relation between Drugmaker and Contractor

Extract from “Managing Contract Manufacturers and Testing Labs

LOGFILE No. 12/2013 - The Brazilian GMP Guideline

21.03.2014

The Brazilian GMP Guideline

By Dr. Hans H. Schicht

LOGFILE No. 10/2013 - Deviations - GMPnews FDA, India and EU

17.03.2014

Deviations – Definition and Requirements

By Dr. Christian Gausepohl

LOGFILE No. 7/2013 - GMP-relevant Documents

06.03.2014

GMP-relevant Documents

By Dr. Michael Hiob

 

LOGFILE No. 5/2013 - Coding and Serialisation

27.02.2014

Coding and Serialisation of Folding Cardboard Boxes in the Pharmaceutical Industry

By Roland Kleissendorf

LOGFILE No. 4/2013 - EU GMP Guidelines 2013

18.02.2014

Which European Guidelines will change in 2013?

By Thomas Peither, Maas & Peither AG - GMP Publishing

LOGFILE No. 3/2013 - Improve Quality Systems - Part II

11.02.2014

Simplification Can Improve Quality Systems, Experts Say Part II

Rebecca Stauffer, PDA

LOGFILE No. 2/2013 - Improve Quality Systems

27.01.2014

Simplification Can Improve Quality Systems, Experts Say Part I

Rebecca Stauffer, PDA

LOGFILE No. 33/2012 - Biological Active Substances

21.01.2014

Comparison of Different Versions of Annex 2 EU Guide to GMP Part I

Maas & Peither AG - GMP Publishing (November 2012)

LOGFILE No. 32/2012 - Change Management

15.01.2014

Principles of Change Control

Author: Michael Hiob, Ph.D., Germany

LOGFILE No. 28/2012 - Pharmaceutical Quality System (EU-GMP Chapter 1)

10.12.2013

Comparison of Different Versions of Chapter 1 EU Guide to GMP Part I

LOGFILE No. 27/2012 - Europe: New "Outsourced Activities"

02.12.2013

Synopsis of Chapter 7 of the EU Guide to GMP

(September 2012)

LOGFILE No. 26/2012 - Good Distribution Practice (GDP)

26.11.2013

Good Distribution Practice - Current Regulations

Author: Thomas Peither, Maas & Peither AG, GMP Publishing

LOGFILE No. 25/2012 - Typical GMP Audit Questions

19.11.2013

10 typical GMP audit questions about electronic records

LOGFILE No. 22/2012 - Contract Manufacturer Agreement

04.11.2013

LOGFILE No. 22/2012 - Contract Manufacturer Agreement

Author: Max Lazar

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