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GMP LOGFILE: Lead Article
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. 14/2013 - GMP Validation Documentation
31.03.2014
Documenting Process Validation: Introduction
Extract from “Documenting Process Validation: A Drugmaker’s Guide”
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. 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
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