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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

LOGFILE No. 38/2014 - GMP Certificates: What do they prove?

08.12.2014

GMP-Compliant Documentation

An excerpt from the GMP MANUAL

by Cornelia Wawretschek

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