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LOGFILE No. 07/2018 – What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 1
21.02.2018
What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 1
6 minutes reading time
A commentary by Ruven Brandes and Fritz Röder
LOGFILE No. 05/2018 – Implementing and Monitoring Data Integrity Measures
06.02.2018
Implementing and Monitoring Data Integrity Measures
An excerpt from the GMP Focus PDF Download Data Integrity in the EU
5 minutes reading time
by Markus Veit, PhD
LOGFILE No. 04/2018 – Key learnings from serialisation projects – Part 2
30.01.2018
Key learnings from serialisation projects – Part 2
6 minutes reading time
by Andrew Love and Stephen McIndoe
LOGFILE No. 03/2018 – Key learnings from serialisation projects – Part 1
23.01.2018
Key learnings from serialisation projects – Part 1
6 minutes reading time
by Andrew Love and Stephen McIndoe
LOGFILE No. 02/2018 – Risk Analysis in the Equipment Life Cycle
16.01.2018
Risk Analysis in the Equipment Life Cycle
An excerpt from the GMP Focus PDF Download Principles of Equipment Qualification
5 minutes reading time
by Ulrike Reuter
LOGFILE No. 06/2018 – Root Cause Analysis – An Essential Enabler
12.01.2018
Root Cause Analysis – An Essential Enabler
An excerpt from the GMP Compliance Adviser, Chapter 20.E Failure Management
8 minutes reading time
by Martin Mayer
LOGFILE No. 01/2018 – Ask Our Experts – Part 2 – 4 GMP-Questions which might be of your interest
09.01.2018
Ask Our Experts – Part 2
4 GMP-Questions which might be of your interest
7 minutes reading time
by Sabine Rabus
LOGFILE No. 46/2017 – International GMP – Six Questions for Jacques Morénas
05.12.2017
International GMP – Six Questions for Jacques Morénas
5 minutes reading time
LOGFILE No. 44/2017 – Intermediate Bulk Container Systems
21.11.2017
Intermediate Bulk Container Systems
An excerpt from the GMP Series PDF Download Technical Solutions for Personal Protection in Solid Drug Manufacturing
5 minutes reading time
by Richard Denk
LOGFILE No. 43/2017 – Indispendsable: The Determination of PDE Values as Exposure Limits
14.11.2017
Indispensable: The Determination of PDE Values as Exposure Limits for Risk Analysis in Shared Facilities
It is not possible to estimate the danger or toxicity of APIs only according to their therapeutic group.
Results of an analysis of 1200 active substances.
8 minutes reading time
by Beatriz Carrero, PhD, Azierta and Sabine Paris, PhD, Maas & Peither – GMP Publishing
LOGFILE No. 42/2017 – Final version of the EMA Q&A paper on WFI production without distillation
10.11.2017
Update: Final version of the EMA Q&A paper on WFI production without distillation
5 minutes reading time
by Fritz Röder
LOGFILE No. 41/2017 – Deviation Management
31.10.2017
Deviations – Definition and Requirements
An excerpt from GMP Series Implementing a World Class Deviation Management
By Dr. Christian Gausepohl
LOGFILE No. 40/2017 – Calibration of laboratory instruments
24.10.2017
Calibration of laboratory instruments
An excerpt of the GMP Compliance Adviser, Chapter 14.D.4
5 minutes reading time
by Josef Künzle, PhD, Wolfgang Nedvidek, PhD
LOGFILE No. 47/2017 – Ask Our Experts – Part 1 – 6 GMP-Questions which might be of interest to You
24.10.2017
Ask Our Experts – Part 1
6 GMP-Questions which might be of interest to you
7 minutes reading time
by Sabine Rabus
LOGFILE No. 39/2017 – Mobile water treatment possible even in the GMP area for the first time!
17.10.2017
Mobile water treatment possible even in the GMP area for the first time!
6 minutes reading time
by Fritz Röder
LOGFILE No. 45/2017 – 8 Golden Rules for Personnel Hygiene
16.10.2017
8 Golden Rules for Personnel Hygiene
An excerpt from the GMP Compliance Adviser, Chapter 11.B.5
4 minutes reading time
by Christian Gausepohl, PhD
LOGFILE No. 38/2017 – MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 2
10.10.2017
MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 2
6 minutes reading time
by Dr. Tim Sandle
LOGFILE No. 37/2017 – Physical monitoring of cleanrooms
04.10.2017
Physical monitoring of cleanrooms
An excerpt from GMP Series Monitoring of HVAC Systems in GMP Environments
by Dr. Hans H. Schicht
LOGFILE No. 36/2017 – MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 1
26.09.2017
MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 1
6 minutes reading time
by Dr. Tim Sandle
LOGFILE No. 35/2017 – Technology Transfer Phases
19.09.2017
Technology Transfer Phases
An excerpt from GMP Series A Successful Concept for Technology Transfer in Drug Manufacturing
5 minutes reading time
by Christian Gausepohl, PhD