GMP LOGFILE: Lead Article

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

Maas & Peither AG - GMP Publishing (November 2012)

Principles of Change Control

Author: Michael Hiob, Ph.D., Germany

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

Synopsis of Chapter 7 of the EU Guide to GMP

(September 2012)

Good Distribution Practice - Current Regulations

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

10 typical GMP audit questions about electronic records

LOGFILE No. 22/2012 - Contract Manufacturer Agreement

Author: Max Lazar

Typical Audit Questions: Laboratory Controls

The Top 10 GMP Deficiencies of PIC/S Members

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

Site Master File – Guidelines for structure, contents and extent

Author: Cornelia Wawretschek, GxP Services

GMP and Personalized Medicine

Author: Thomas Peither, Maas & Peither AG

Outsourcing qualification activities to suppliers

Authors: Ulrike Reuter, Germany; Max Lazar, USA

The “V model”

Author: Markus Roemer

Risk Analysis RA2x5

Author: Thomas Peither

EMA Draft for Process Validation

Author: Thomas Peither

The Importance of Commenting on Public Standards

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

Aseptic Processing: Qualification of personnel

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

USP and IPEC-Europe Weigh in on GDPs for Excipients

An article by IPQ Publications

The New Quality Paradigm

Author: Dr. Siegfried Schmitt

Inspection of suppliers

Authors: Dr. Michael Hiob, Max Lazar