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GMP LOGFILE: Lead Article

LOGFILE No. 03/2016 - Limit Values for Cleaning Processes - Part 2

24.01.2017

Limit Values for Cleaning Processes:
Implementing Toxicological Risk Assessment – Part 2

(5 min. reading time)

by Dr. Sabine Paris

 

LOGFILE No. 02/2017 - Limit Values for Cleaning Processes - Part 1

17.01.2017

Limit Values for Cleaning Processes:
Implementing Toxicological Risk Assessment – Part 1

(5 min. reading time)

by Dr. Sabine Paris

 

LOGFILE No. 01/2017 - Alert and action levels and specifications

10.01.2017

Alert and action levels and specifications

An excerpt from the USP <1231> Download

by Fritz Röder

LOGFILE No. 45/2016 – Rework: What has to be observed?

06.12.2016

Rework: What has to be observed?

An excerpt from the GMP MANUAL

by Dr. Christian Gausepohl

LOGFILE No. 43/2016 – Line Clearance

22.11.2016

Line Clearance

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

by Ruven Brandes, Dr. Christian Gausepohl

LOGFILE No. 42/2016 – Transport Validation

15.11.2016

Transport Validation

An excerpt from the GMP Focus download Creating a Master Plan for Drug Warehousing, Transportation and Distribution

by Dr. Christoph Frick, Dr. Nicola Spiggelkötter

 

LOGFILE No. 08/2017 – Self-Inspection Q&A

11.11.2016

Self-Inspection Q&A

(4 min. reading time)

by Dr. Doris Borchert and Dr. Sabine Paris

LOGFILE No. 41/2016 – The qualification life cycle concept and tools: an overview

08.11.2016

The qualification life cycle concept and tools: an overview

An excerpt from the GMP MANUAL

by Ulrike Reuter

LOGFILE No. 39/2016 – Managing Process Validation

18.10.2016

Validation Planning

An excerpt from the GMP Focus download Managing Process Validation: A Drugmaker's Guide

by Dr. Christine Oechslein

 

LOGFILE No. 38/2016 – PDA/FDA Joint Regulatory Conference 2016

11.10.2016

Evolution and a Touch of GMP Revolution at the PDA/FDA JRC 2016

(Reading time 5 min + 3 min video)

by Thomas Peither

LOGFILE No. 37/2016 - Preparing for the EU GMP Inspection

05.10.2016

Self-Inspection

An excerpt from the GMP Focus PDF Download Preparing for the EU GMP Inspection

by Dr. Christian Gausepohl and Max Lazar

 

LOGFILE No. 36/2016 – Draft EMA Q&A paper on production of WFI non-distillation methods

27.09.2016

Not yet all clear: Draft EMA Q&A paper on production of WFI by non-distillation methods

An interview with Fritz Röder

LOGFILE No. 35/2016 – Successful Handling of OOX Results

20.09.2016

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. 34/2016 – The Changing Concept of Validation

13.09.2016

The changing concept of validation

An excerpt from the GMP MANUAL

by Dr. Christine Oechslein

LOGFILE No. 33/2016 – Achieving “Quality beyond Compliance” is a Matter of Leadership

02.09.2016

Achieving “Quality beyond Compliance” is a Matter of Leadership

by Thomas Peither

LOGFILE No. 46/2016 - Quality Metrics - What will the FDA require in the future? How are companies already benefitting today?

02.09.2016

Quality Metrics – What will the FDA require in the future? How are companies already benefitting today?

(5 min. reading time)

by Dr. Sabine Paris

LOGFILE No. 31/2016 – Separate Device Specification for the FDA?

23.08.2016

Separate Device Specification for the FDA?
Your question - our answer

by Thomas Peither

LOGFILE No. 44/2016 – Managing Contract Maufacturers and Testing Labs

15.08.2016

Managing Contract Manufacturers and Testing Labs

An excerpt from the GMP Focus download Managing Contract Manufacturers and Testing Labs

by Dr. Christian Gausepohl, Dr. Frank Böttcher

LOGFILE No. 30/2016 – Don’t Be a Daredevil When Retrofitting Your Facility

02.08.2016

Don’t Be a Daredevil When Retrofitting Your Facility

by Bob Ferer

LOGFILE No. 28/2016 – Roadmap to Manage Personnel in Pharmaceutical Manufacturing

19.07.2016

Roadmap to Manage Personnel in Pharmaceutical Manufacturing

GMP Series PDF Download

An excerpt from the GMP MANUAL

by Michael Hiob

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