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GMP LOGFILE: Lead Article
LOGFILE No. 34/2015 – Risk Management in Transportation
29.05.2015
Risk Management in Transportation
An excerpt of the GMP MANUAL
by Dr. Nicola Spiggelkoetter
LOGFILE No. 32/2015 – Older Pharmaceutical Factories
27.05.2015
Older Pharmaceutical Factories – What does the FDA have to say?
by Thomas Peither
LOGFILE No. 31/2015 – Material flow, personnel flow and layout of premises
13.05.2015
GMP MANUAL Update 22
Short Summary of the updated chapter 3.B on material flow, personnel flow and layout of premises
by Andreas Nuhn
LOGFILE No. 30/2015 – Quality Metrics - Bane or Boon?
04.05.2015
Quality Metrics - Bane or Boon?
by Thomas Peither
LOGFILE No. 28/2015 - Risk Evaluation - more than just data and facts
28.04.2015
Risk Evaluation - more than just data and facts
An excerpt from the PDA/DHI publication Risk Assessment and Risk Management in the Pharmaceutical Industry - Clear and Simple
by James L. Vesper
LOGFILE No. 26/2015 - General principles of hygienic design
21.04.2015
General principles of hygienic design
An excerpt of the GMP MANUAL
by Richard Denk
LOGFILE No. 24/2015 - Cleaning Engineering: Flow and Coverage in Process Piping
13.04.2015
Cleaning Engineering: Flow and Coverage in Process Piping
An excerpt from the PDA/DHI publication Cleaning and Cleaning Validation
by George Verghese and Paul Lopolito
LOGFILE No. 22/2015 – Reverse osmosis also allowed for future WFI production
31.03.2015
Reverse osmosis also allowed for future WFI production
An interview with Ruven Brandes
by Dr. Sabine Paris
LOGFILE No. 20/2015 – Laboratory data management systems (LDMS)
25.03.2015
Advantages of laboratory data management systems (LDMS)
An excerpt of the GMP MANUAL
by Dr. Ulf Fuchslueger
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