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GMP LOGFILE: Lead Article

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

LOGFILE No. 02/2016 – Intermediate bulk container systems

14.09.2015

Intermediate bulk container systems

An excerpt from the GMP Series PDF Download 
Technical Solutions for Personal Protection in Solid Drug Manufacturing

An excerpt from the GMP MANUAL

by Richard Denk

LOGFILE No. 01/2016 – 2016 - GMP in Production

14.08.2015

2016 – GMP in Production

by Thomas Peither

LOGFILE No. 48/2015 – Managing Outsourced GMP Activities Successfully

14.08.2015

Managing Outsourced GMP Activities Successfully

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Dr. Frank Böttcher and Dr. jur. Ingo Schneider

LOGFILE No. 47/2015 – Transportation

14.08.2015

How do you transport and store medicinal products? Here is what you have to know!

by Dr. Sabine Paris

LOGFILE No. 45/2015 – Reasons for Outsourcing

10.08.2015

Reasons for Outsourcing

An excerpt from the GMP MANUAL

by Dr. Frank Böttcher

LOGFILE No. 44/2015 – Organization of audits

07.08.2015

Organization of Audits

An excerpt of the GMP-Audit-Checklist

by Dr. Michael Hiob and Max Lazar

LOGFILE No. 43/2015 – Particle Monitoring

03.08.2015

Particle Monitoring

An excerpt from the GMP MANUAL

by Thomas von Kahlden

LOGFILE No. 42 / 2015 – How to deal with OOX Results

22.07.2015

Receiving the OOS result and starting the OOS process

An Excerpt from the GMP Series PDF Download Industry Guide to handle OOX Test Results

by Dr. Markus Limberger

LOGFILE No. 41/2015 – Checklist Performance Qualification

20.07.2015

Checklist Performance Qualification

An Excerpt from the GMP Series PDF Download The Ultimate Checklist for Premises and HVAC Qualification

by Dr. Hans H. Schicht

LOGFILE No. 40/2015 – The purpose of GMP

07.07.2015

The purpose of GMP

An excerpt of GMP Fundamentals

by Dr. Christine Oechslein

LOGFILE No. 39/2015 – Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers

06.07.2015

Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Stefan Kettelhoit

LOGFILE No. 38/2015 – Roadmap to Manage Personnel in Pharmaceutical Manufacturing

30.06.2015

Roadmap to Manage Personnel in Pharmaceutical Manufacturing

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Michael Hiob

LOGFILE No. 37/2015 – How to Manage Corrective and Preventive Actions

23.06.2015

How to Manage Corrective and Preventive Actions (CAPA) in GMP Environment

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Bernd Renger

LOGFILE No. 36/2015 – What is quality management?

15.06.2015

What is quality management?

An excerpt from GMP Fundamentals

by Dr. Christine Oechslein

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