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GMP LOGFILE: Lead Article

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

LOGFILE No. 07/2012 - GMP Inspection of suppliers

17.07.2013

Inspection of suppliers

Authors: Dr. Michael Hiob, Max Lazar

LOGFILE No. 06/2012 - Monitoring of HVAC systems

01.07.2013

Monitoring of HVAC Systems

  • Objectives of process monitoring

  • Data management stipulations

  • Air cleanliness and other room air data

Author: Dr. Hans Schicht

LOGFILE No. 04/2012 - GMP Guidelines 2012

26.06.2013

GMP-Guidelines: What can we expect in 2012?

Author: Anita Maas, Maas & Peither AG

LOGFILE No. 03/2012 - Process Validation

11.06.2013

Process validation from the viewpoint of the FDA

Authors: Dr. Christine Oechslein, GMP Instructor, Germany and Max S. Lazar, FDA Regulatory Compliance Consulting, USA

LOGFILE No. 1/2012 - January 2012

28.05.2013

Contract Manufacture: Duties of the Contract Giver

from Max S. Lazar

LOGFILE No. 17/2011 - December 2011

14.05.2013

REGULATORY UPDATE October 2011

 

LOGFILE No. 15/2011 - November 2011

06.05.2013

Which Risk Assessment fits best?

Authors: S. Roenninger, M. Hertlein

LOGFILE No. 14/2011 - November 2011

29.04.2013

Temperature Profiles

Author: Nicola Spiggelkötter Ph. D.

LOGFILE No. 09/2013 - An Introduction to PQR and APR

27.03.2013

Product Quality Review and Annual Product Review

By Dr. Christian Gausepohl

LOGFILE No. 2/2013 - Improve Quality Systems

16.01.2013

Simplification Can Improve Quality Systems, Experts Say Part I

Rebecca Stauffer, PDA

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