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GMP LOGFILE: Lead Article

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

LOGFILE No. 21/2012 - Laboratory Controls - GMP Audit Questions

04.11.2013

Typical Audit Questions: Laboratory Controls

LOGFILE No. 20/2012 - Top 10 GMP Deficiencies

28.10.2013

The Top 10 GMP Deficiencies of PIC/S Members

Author: Thomas Peither
Maas & Peither GMP Publishing, Germany, USA

LOGFILE No. 19/2012 - Site Master File (SMF)

22.10.2013

Site Master File – Guidelines for structure, contents and extent

Author: Cornelia Wawretschek, GxP Services

LOGFILE No. 18/2012 - GMP and Personalized Medicine

15.10.2013

GMP and Personalized Medicine

Author: Thomas Peither, Maas & Peither AG

LOGFILE No. 17/2012 - Transfer of qualification activities to suppliers

08.10.2013

Outsourcing qualification activities to suppliers

Authors: Ulrike Reuter, Germany; Max Lazar, USA

LOGFILE No. 16/2012 - Computer System Validation

30.09.2013

The “V model”

Author: Markus Roemer

LOGFILE No. 15/2012 - GMP Risk Analysis RA 2x5

23.09.2013

Risk Analysis RA2x5

Author: Thomas Peither

LOGFILE No. 14/2012 - EMA Draft for Process Validation

17.09.2013

EMA Draft for Process Validation

Author: Thomas Peither

LOGFILE No. 13/2012 - Commenting on USP Standards

29.08.2013

The Importance of Commenting on Public Standards

Authors: Sue Schniepp, OSO Biopharmaceutical and Janeen Skutnik-Wilkinson, Pfizer

LOGFILE No. 12/2012 - Qualification of Personnel

27.08.2013

Aseptic Processing: Qualification of personnel

Author: Dipl.-Ing. (FH) Ruven Brandes, WDT eG, Germany

LOGFILE No. 11/2012 - GDPs for Excipients

07.08.2013

USP and IPEC-Europe Weigh in on GDPs for Excipients

An article by IPQ Publications

LOGFILE No. 09/2012 - Quality by Design (QdB)

24.07.2013

The New Quality Paradigm

Author: Dr. Siegfried Schmitt

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