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GMP LOGFILE: Lead Article
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
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