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GMP LOGFILE: Lead Article

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

LOGFILE No. 36/2014 - EDMF/ASMF and CEP

17.11.2014

EDMF/ASMF and CEP

An excerpt from the GMP MANUAL

by Dr. Stefan Kettelhoit

 

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. 28/2014 - Integrated Quality Risk Management

31.10.2014

Integrated Quality Risk Management

An excerpt from the GMP MANUAL

by Martin Mayer

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

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