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GMP LOGFILE: Lead Article
LOGFILE No. 20/2018 – Practical Issues on Supply Chain and Good Distribution Practice
27.04.2018
Practical Issues on Supply Chain and Good Distribution Practice
A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017
6 minutes reading time
by Susanne Sailer
LOGFILE No. 19/2018 – 2017 - The GMP Regulations Report
19.04.2018
2017 – The GMP Regulations Report
by Sabine Rabus
LOGFILE No. 18/2018 – The Never-Ending Story of Annex 1 and the Obstacles of Aseptic Processing
16.04.2018
The Never-Ending Story of Annex 1 and the Obstacles of Aseptic Processing
A report on the ISPE European Annual Meeting 2018
8 minutes reading time
by Thomas Peither
LOGFILE No. 16/2018 – Industry 4.0 - Inspiration for the Pharmaceutical Industry?
09.04.2018
Industry 4.0 - Inspiration for the Pharmaceutical Industry?
A report on the ISPE European Annual Meeting 2018
8 minutes reading time
by Thomas Peither
LOGFILE No. 15/2018 – Principles of Qualification
03.04.2018
Principles of Qualification
An excerpt from the GMP Series PDF Download Qualification and Validation: Agency Expectations
6 minutes reading time
by Michael Hiob, PhD
LOGFILE No. 14/2018 – Inspections & Audits: Pitfalls and Criteria for Success – Part 2
26.03.2018
Inspections & Audits: Pitfalls and Criteria for Success – Part 2
A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017
6 minutes reading time
by Sabine Rabus and Christine Gräßlin
LOGFILE No. 10/2018 – What a Qualified Person must know about the recent cleaning validation updates – Part 1
13.03.2018
What a Qualified Person must know about the recent cleaning validation updates – Part 1
6 minutes reading time
by Walid El Azab
LOGFILE No. 13/2018 – Inspections & Audits: Pitfalls and Criteria for Success – Part 1
12.03.2018
Inspections & Audits: Pitfalls and Criteria for Success – Part 1
A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017
4 minutes reading time
by Sabine Rabus and Christine Gräßli
LOGFILE No. 09/2018 – General principles of hygienic design
06.03.2018
General principles of hygienic design
An excerpt from the GMP Series PDF Download Applying the Principles of Hygienic Design to Solid Dosage Forms
8 minutes reading time
by Richard Denk
LOGFILE No. 12/2018 – Sampling Frequencies
05.03.2018
Sampling Frequencies
An excerpt from the GMP Series PDF Download Microbiological Monitoring in Pharmaceutical Manufacturing
6 minutes reading time
by Hanfried Seyfarth, PhD
LOGFILE No. 08/2018 – What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 2
27.02.2018
What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 2
6 minutes reading time
A commentary by Ruven Brandes and Fritz Röder
LOGFILE No. 11/2018 – What a Qualified Person must know about the recent cleaning validation updates – Part 2
22.02.2018
What a Qualified Person must know about the recent cleaning validation updates – Part 2
6 minutes reading time
by Walid El Azab
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