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GMP LOGFILE: Lead Article

LOGFILE No. 20/2016 – Quality Metrics - Bane or Boon?

19.05.2016

Quality Metrics – Bane or Boon?

GMP Talk with Experts Claudia Pachl and Ruven Brandes

by Dr. Sabine Paris

LOGFILE No. 19/2016 – Microbiological monitoring of cleanrooms – regulatory requirements

17.05.2016

Microbiological monitoring of cleanrooms – regulatory requirements

Excerpt from the GMP Series pdf download Monitoring of HVAC Systems in GMP Environments

by Dr. Hans H. Schicht

LOGFILE No. 18/2016 – Problems with the Regulatory Culture

10.05.2016

Problems with the Regulatory Culture

by Robert G. Kieffer, Ph.D.

LOGFILE No. 17/2016 – Air cleanliness grades and associated process steps

03.05.2016

Air cleanliness grades and associated process steps

Excerpt from the GMP Series pdf download Classes and Grades for Air Cleanliness

by Dr. Hans H. Schicht

LOGFILE No. 16/2016 – Work instructions, records and documentation

25.04.2016

Work instructions, records and documentation –
How do you keep track?

An excerpt from GMP Fundamentals

by Dr. Christine Oechslein

LOGFILE No. 15/2016 – The New Annex 16 – Eight Questions for Dr. Rainer Gnibl

15.04.2016

The New Annex 16 – Eight Questions for Dr. Rainer Gnibl

LOGFILE No. 14/2016 – Laboratory data management systems (LDMS)

08.04.2016

Laboratory data management systems (LDMS)

An excerpt from GMP Series How to design a Laboratory Data Management System

by Dr. Ulf Fuchslueger

LOGFILE No. 12/2016 – Cytostatic Safety Cabinets

24.03.2016

Specifications for packaging materials

An excerpt from GMP Series Sterile Manufacturing: Barrier Systems, Isolator and Safety Cabinets

by Andreas Nuhn, Dr. Hans H. Schicht

LOGFILE No. 11/2016 – What does the new Annex 1 have in store for us?

17.03.2016

What does the new Annex 1 have in store for us?

by Thomas Peither, Maas & Peither AG

LOGFILE No. 21/2016 – Qualification of Single-Use Component: The Need for Standardization

17.03.2016

Qualification of Single-Use Component: The Need for Standardization

by Christopher Smalley

LOGFILE No. 10/2016 – Storage and shelf life of laboratory substances

07.12.2015

Storage and shelf life of laboratory substances

An excerpt from the GMP MANUAL

by Dr. Markus Limberger

LOGFILE No. 09/2016 – Specifications for packaging materials

23.11.2015

Specifications for packaging materials

An excerpt from GMP Series GMP Compliance Basics of Packaging Materials and Processes

by Ruven Brandes, Dr. Christian Gausepohl, Roland Kleissendorf

LOGFILE No. 08/2016 – Types of Biotechnological Active Substances

16.11.2015

Types of Biotechnological Active Substances

An excerpt from GMP Series Managing GMP Requirements in Biotech API Manufacturing

by Dr. Rainer Gnibl

LOGFILE No. 07/2016 – Physical monitoring of cleanrooms

09.11.2015

Physical monitoring of cleanrooms

An excerpt from GMP Series Monitoring of HVAC Systems in GMP Environments

By Dr. Hans H. Schicht

LOGFILE No. 06/2016 – Technology Transfer Phases

04.11.2015

Technology Transfer Phases

An excerpt from GMP Series A Successful Concept for Technology Transfer in Drug Manufacturing

By Dr. Christian Gausepohl

LOGFILE No. 05/2016 – Process Validation

23.10.2015

Process Validation – How do I implement the new GMP requirements?

Results of the GMP Conference in 2015

Report by Dr. Sabine Paris

LOGFILE No. 04/2016 – Deviation Management

13.10.2015

Deviations – Definition and Requirements

An excerpt from GMP Series Implementing a World Class Deviation Management

By Dr. Christian Gausepohl

LOGFILE No. 03/2016 – Possible risks of manufacturing and packaging

25.09.2015

Possible risks of manufacturing and packaging

An excerpt from GMP Fundamentals 

by Dr. Christine Oechslein

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