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GMP LOGFILE: Lead Article
LOGFILE No. 27/2018 – Pharmaceutical Industry Highlights - Past, Present, Future
02.07.2018
Pharmaceutical Industry Highlights - Past, Present, Future
A report on the PDA European Annual Meeting 2018 – Part 1
6 minutes reading time
by Thomas Peither
LOGFILE No. 26/2018 – Principles of Cleaning Process Requirements
22.06.2018
Principles of Cleaning Process Requirements
An excerpt from the GMP Series PDF Download A Pharma Guide to Cleaning Validation
6 minutes reading time
by Michael Hiob, PhD
LOGFILE No. 25/2018 – The clock is ticking on the new EU Medical Devices and In Vitro Diagnostic Devices Regulations
15.06.2018
The clock is ticking on the new EU Medical Devices and In Vitro Diagnostic Devices Regulations
10 minutes reading time
by Andrew Love
LOGFILE No. 24/2018 – GDP Questionnaire - Transportation
11.06.2018
GDP Questionnaire - Transportation
An excerpt from the GDP Questionnaire
5 minutes reading time
by Simone Ferrante
LOGFILE No. 23/2018 – PQ: The Link between Qualification and Validation
17.05.2018
PQ: The Link between Qualification and Validation
An excerpt from the GMP Compliance Adviser, Chapter 6.G Performance Qualification
6 minutes reading time
by Thomas Peither, Ulrike Reuter, Rainer Röcker
LOGFILE No. 22/2018 – Data Integrity and the Problem of Getting It Done
16.05.2018
Data Integrity and the Problem of Getting It Done
A report on the ISPE European Annual Meeting 2018
8 minutes reading time
by Thomas Peithe
LOGFILE No. 21/2018 – Effectively Dealing with OOX Results
07.05.2018
Test results outside defined criteria (OOX)
An excerpt of the GMP Series Download Industry Guide to handle OOX Test Results
by Dr. Markus Limberger
LOGFILE No. 17/2018 – Layout of a Cleanroom Air Handling Unit
02.05.2018
Layout of a Cleanroom Air Handling Unit
An excerpt from the GMP Compliance Adviser, Chapter 3.I Air Handling Technology
6 minutes reading time
by Harald Flechl
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