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GMP LOGFILE: Lead Article
LOGFILE Feature 21/2019 – The aims and basic principles of the PQS
04.06.2019
The aims and basic principles of the PQS
An excerpt from the new e-book The Road to a Pharmaceutical Quality System
4 minutes reading time
by Stephanie Blum, PhD
LOGFILE Feature 20/2019 – ICH Q12 - Set menu or buffet?
28.05.2019
ICH Q12 - Set menu or buffet?
A Report on the 2019 ISPE Europe Annual Conference
6 minutes reading time
by Sabine Paris, PhD
LOGFILE Feature 19/2019 – GMP training courses in the online offline tension field
21.05.2019
GMP training courses in the online offline tension field
A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2018
5 minutes reading time
by Sabine Paris, PhD
LOGFILE Feature 18/2019 – The power of the comma, or: What do print data have to do with drug safety?
14.05.2019
The power of the comma
Or: What do print data have to do with drug safety?
6 minutes reading time
by Doris Borchert, PhD
LOGFILE 17/2019 – Drive and Leverage Innovation for Pharma
07.05.2019
Drive and Leverage Innovation for Pharma
A Report on the 2019 ISPE Europe Annual Conference
7 minutes reading time
by Sabine Paris, PhD
LOGFILE 16/2019 – How to Manage ICH Q3D Risk Assessments with Change Control Management
30.04.2019
How to Manage ICH Q3D Risk Assessments with Change Control Management
9 minutes reading time
by Paulino Alonso
LOGFILE 15/2019 – Risk Analysis in the Equipment Life Cycle
23.04.2019
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 14/2019 – The answer is? FDA publishes final data integrity Q&A
16.04.2019
The answer is? FDA publishes final data integrity Q&A
A commentary by Tim Sandle
LOGFILE 13/2019 – Calibration of Laboratory Instruments
09.04.2019
Calibration of Laboratory Instruments
An excerpt from the new GMP Series Download Qualification and Calibration of Laboratory Instruments in Pharmaproduction
5 minutes reading time
by Josef Künzle, PhD
LOGFILE 12/2019 – Clean air in non-sterile production areas
02.04.2019
Clean air in non-sterile production areas
Results of an online survey
8 minutes reading time
by Doris Borchert, PhD
LOGFILE 11/2019 – Risk Analysis of a Pharmaceutical Water System
27.03.2019
Risk Analysis of a Pharmaceutical Water System
An excerpt from the GMP Series PDF Download Qualification of Pharma Water Supply Systems
5 minutes reading time
by Fritz Röder
LOGFILE 10/2019 – Areas of Application for E-Learning and Advantages of E-Learning
19.03.2019
Areas of Application for E-Learning and Advantages of E-Learning
4 minutes reading time
by Christine Oechslein, PhD
LOGFILE 09/2019 – Is monitoring (of germs and particles) required in “unclean airlock areas” for non-sterile production?
12.03.2019
Is monitoring (of germs and particles) required in “unclean airlock areas” for non-sterile production?
Ask our experts
5 minutes reading time
by Doris Borchert, PhD
LOGFILE 08/2019 – New Technologies for Cleanroom Planning
05.03.2019
New Technologies for Cleanroom Planning
Excerpt from the GMP Compliance Adviser, Chapter 3.E.4
4 minutes reading time
by Harald Flechl, Senior Engineer
LOGFILE 07/2019 – Annex 1 - Sterile and Aseptic Production Facing New Challenges
26.02.2019
Annex 1 - Sterile and Aseptic Production Facing New Challenges
A Summary of the GMP DIALOGUE at the GMP-BERATER Tage 2018
8 min. reading time
by Dr Sabine Paris
LOGFILE 06/2019 – The GMP Regulations Report 2018
19.02.2019
The GMP Regulations Report 2018
by Sabine Rabus
LOGFILE No. 05/2019 – GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment
05.02.2019
GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment
Excerpt from the GMP Series Download GMP Supplier Assessment Questionnaire
4 minutes reading time
by Cornelia Wawretschek
LOGFILE No. 04/2019 – DT When and how must OOS examinations be triggered?
29.01.2019
When and how must OOS examinations be triggered?
Your question - Our answer
6 minutes reading time
by Doris Borchert, PhD
LOGFILE No. 03/2019 – Microbiological Monitoring: Actions when levels are exceeded
22.01.2019
Microbiological Monitoring: Actions when levels are exceeded
Excerpt from the GMP Compliance Adviser, Chapter 10.E
5 minutes reading time
by Hanfried Seyfarth, PhD
LOGFILE No. 02/2019 – Who may carry out the sampling?
08.01.2019
Who may carry out the sampling?
Ask our experts
5 minutes reading time
by Doris Borchert, PhD