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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. 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