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GMP LOGFILE: Lead Article
LOGFILE No. 17/2015 – Types of Biotechnological Active Substances
19.03.2015
Types of Biotechnological Active Substances
An excerpt of the GMP MANUAL
by Dr. Rainer Gnibl
LOGFILE No. 15/2015 – Reduce Human Error in a GMP Facility
06.03.2015
Reduce Human Error in a GMP Facility
by Claire Newcombe, Applied Biopharm Consultancy, Shanon McKenna , PAREXEL, Anthony Newcombe, PhD, PAREXEL
LOGFILE No. 07/2015 - Project management of facility construction
25.02.2015
Project management of facility construction
An excerpt of the GMP MANUAL
by Thomas Peither
LOGFILE No. 13/2015 – Continuous Manufacturing - the FDA Perspective
09.02.2015
Continuous Manufacturing
– the FDA perspective on the future of medicinal product manufacturing –
by Dr. Sabine Paris
LOGFILE No. 11/2015 - Preventing Cross-Contamination
09.02.2015
Preventing Cross-Contamination
In a highly acclaimed talk held during our GMP Symposium, Richard Denk elucidated the risk factors for contamination and the influence of highly active substances.
by Susanne Sailer
LOGFILE No. 09/2015 - Principles of blow-fill-seal technology
02.02.2015
Principles of blow-fill-seal technology
An excerpt of the GMP MANUAL
by Dr. Manfred Grüneberg
LOGFILE No. 09/2015 - Principles of blow-fill-seal technology
02.02.2015
Principles of blow-fill-seal technology
An excerpt of the GMP MANUAL
by Dr. Manfred Grüneberg
LOGFILE No. 05/2015 - Qualification and ATP Classification
27.01.2015
What you must know about qualification and ATP classification of lorries
by Thomas Peither
LOGFILE No. 03/2015 - Effectively dealing with OOX Results
19.01.2015
Test results outside defined criteria (OOX)
by Dr. Markus Limberger
LOGFILE No. 01/2015 - GMP-Outlook 2015
12.01.2015
GMP-Outlook 2015: What to expect in the world of GMP?
by Thomas Peither
LOGFILE No. 36/2014 - EDMF/ASMF and CEP
17.11.2014
LOGFILE No. 34/2014 - Safety in the workplace
07.11.2014
Safety in the workplace / Occupational health and safety
An excerpt from the GMP MANUAL
by Dr. Michael Hiob
LOGFILE No. 24/2014 - Risk Assessment of Excipients
27.10.2014
Excipients – Risks and their Assessment
by Dr. Stephanie Blum
LOGFILE No. 22/2014 - Electronic Training Systems
20.10.2014
Electronic Training Systems
An excerpt from the GMP MANUAL
by Dr. Michael Hiob
LOGFILE No. 20/2014 - Quality Assurance
20.10.2014
The Role of Quality Assurance within the Pharmaceutical Quality System
by Dr. Bernd Renger
LOGFILE No. 18/2014 - Knowledge Management
14.10.2014
Knowledge Management is the Next Risk Management
by Thomas Peither
LOGFILE No. 16/2014 - EU GMP-Guide Revisions
06.10.2014
How do new developments find their way into the EU GMP Guide?
What is the present status of the revision of the EU GMP Guide?
by Dr. Sabine Paris
LOGFILE No. 14/2014 - Quality is more than GMP Compliance
29.09.2014
There's More to Quality than GMP Compliance
by Thomas Peither