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GMP LOGFILE: Lead Article

LOGFILE No. 28/2013 - Process Validation Trends - GMP News

30.06.2014

Process Validation Trends

By Susanne Sailer

 

LOGFILE No. 27/2013 - Industry Perspective on Quality Agreements - GMP News

23.06.2014

Quality Agreements: How to build a relationship? (Part II)

By Thomas Peither

LOGFILE No. 26/2013 - Quality Risk Management - GMP News

16.06.2014

There's More to Risk Management than Just Risk Analysis

by Susanne Sailer

LOGFILE No. 25/2013 - Excipients - Surprise FDA inspections in India

02.06.2014

Excipients - Safety, toxicological, and precedence of use issues

by Iain Moore, Ph. D

LOGFILE No. 24/2013 - Outsourcing - Quality Agreements - GMP News

26.05.2014

Quality Agreements: How to build a relationship? (Part I)

By Thomas Peither

LOGFILE No. 23/2013 - GMP Audit Checklist

19.05.2014

Buildings and Infrastuctrue

an excerpt from the GMP Audit Checklist

LOGFILE No. 22/2013 - PDA/FDA Joint Conference

12.05.2014

What is the Future Interpretation of GMPs?

By Thomas Peither

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

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