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GMP LOGFILE: Lead Article

LOGFILE No. 23/2017 – Changes in USP <1231>: Water for Pharmaceutical Purposes

13.06.2017

Changes in USP <1231>: Water for Pharmaceutical Purposes

8 min. reading time

by Fritz Röder

LOGFILE No. 21/2017 – Quality Agreement – A Sample Document

31.05.2017

Quality Agreement – A Sample Document

An excerpt from the GMP Series Quality Agreement

by Dr. Christine Oechslein

 

 

 

LOGFILE No. 21/2017 – Quality Agreement – A Sample Document

30.05.2017

Quality Agreement – A Sample Document

An excerpt from the GMP Series Quality Agreement

by Dr. Christine Oechslein

LOGFILE No. 20/2017 – 85 Questions You Should Ask Your Contract Manufacturer / Contract Lab

23.05.2017

85 Questions You Should Ask Your Contract Manufacturer / Contract Lab

An excerpt from the GMP Series GMP-Questionnaire: Contract Manufacturing / Contract Analysis

by Dr. Christine Oechslein

LOGFILE No. 19/2017 – Complex Product and Process Flows

16.05.2017

A Challenge: Complex Product and Process Flows

An excerpt from the GMP Compliance Adviser (formerly GMP MANUAL), Chapter 14.J.8 and 14.J.8.1

3 min. reading time

by Rainer Gnibl

LOGFILE No. 27/2017 – Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

12.05.2017

Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

A report on the ISPE 2017 Europe Annual Conference

6 minutes reading time

by Sabine Paris, PhD

LOGFILE No. 18/2017 – Data Integrity is a Must!

09.05.2017

Data Integrity is a Must!

5 min. reading time

A contribution from Thomas Peither

LOGFILE No. 17/2017 – Chemical Active Substances - Special Risks

03.05.2017

Chemical Active Substances – Special Risks

An excerpt from the GMP Series Practice Guide for Conducting Audits of Chemical Active Substance Manufacturers

4 min. reading time

by Stefan Kettelhoit, PhD

LOGFILE No. 16/2017 – 130 Elements You Need for a World-Class Technical Agreement

25.04.2017

130 Elements You Need for a World-Class Technical Agreement

An excerpt from the GMP Series Technical Agreement and Delimitation of Pharmaceutical Responsibilities

by Dr. Christine Oechslein

LOGFILE No. 15/2017 – Formalizing a Risk Assessment for Excipients

18.04.2017

Formalizing a Risk Assessment for Excipients

by Frithjof Holtz

 

LOGFILE No. 13/2017 - Comment to the Revision of the Note for Guidance on Quality of Water for Pharmaceutical Use

04.04.2017

“Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)”

A comment by Fritz Röder and Ruven Brandes

(reading time 5 min)

by Fritz Röder and Ruven Brandes

LOGFILE No. 22/2017 – Independent and Linked CAPA Systems

31.03.2017

Independent and Linked CAPA Systems

An excerpt from the GMP Series How to Manage Corrective and Preventive Actions (CAPA) in a GMP Environment

3 min. reading time

by Dr. Bernd Renger

LOGFILE No. 12/2017 - Document Access for GMP inspectors and Auditors of Notified Bodies

29.03.2017

Document Access for GMP Inspectors and Auditors of Notified Bodies

Your question – our answer – Part 2

(5 min. reading time)

by Dr. Sabine Paris

LOGFILE No. 11/2017 – 24 GMP documents you should know about

21.03.2017

 

24 GMP documents You Should Know About–

A Concise Review of Everything New in 2016

by Sabine Rabus

LOGFILE No. 10/2017 – What do GMP compliance and GEP mean?

14.03.2017

What do GMP compliance and GEP mean?

An excerpt from the GMP Compliance Adviser

(4 min. reading time)

by Thomas Peither

LOGFILE No. 09/2017 - The Process of Freeze-Drying

07.03.2017

Temperature monitoring and control

An excerpt from the GMP Series The Process of Freeze-Drying

(3 min. reading time)

by Dr. Margit Gieseler

 

LOGFILE No. 07/2017 – Executing Sterile Filtration

21.02.2017

Executing Sterile Filtration

An excerpt from the GMP Series download Aseptic Processing of Sterile Medicinal Products

by Ruven Brandes

LOGFILE No. 05/2017 – Sampling Frequencies

07.02.2017

Sampling Frequencies

An excerpt from the GMP Series download Microbiological Monitoring in Pharmaceutical Manufacturing

by Dr. Hanfried Seyfarth

LOGFILE No. 04/2017 – Managing Outsourced GMP Activities Successfully

31.01.2017

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. 14/2017 - 170 Questions You Should Ask Your Supplier

30.01.2017

170 Questions You Should Ask Your Supplier

An excerpt from the GMP Series GMP Supplier Assessment Questionnaire

3 min. reading time

by Cornelia Wawretschek

 

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