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GMP LOGFILE: Lead Article
LOGFILE No. 39/2018 – Batch release process steps
09.10.2018
Batch release process steps
An excerpt from the new GMP Series PDF Download EU-Compliant Batch Release of Medicinal Products
6 minutes reading time
by Rainer Gnibl, PhD
LOGFILE No. 38/2018 – Blockchain: Will it Transform the Pharmaceutical Supply Chain?
09.10.2018
Blockchain: Will it Transform the Pharmaceutical Supply Chain?
6 minutes reading time
by Mark Crawford
LOGFILE No. 37/2018 – What is the point of "heating" medicinal products to 15–25 °C?
25.09.2018
What is the point of "heating" medicinal products to 15–25 °C?
A case study challenging conventional limits
An excerpt from the GMP Compliance Adviser, Chapter 24.F
6 minutes reading time
by Christoph Frick, PhD
LOGFILE No. 36/2018 – Calibration of Laboratory Instruments
20.09.2018
Calibration of Laboratory Instruments
An excerpt from the new GMP Series PDF Download Qualification and Calibration of Laboratory Instruments in Pharmaproduction
5 minutes reading time
by Josef Künzle, PhD
LOGFILE No. 35/2018 – Quality Oversight and Lean QA
13.09.2018
Quality Oversight and Lean QA
A Summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017
6 minutes reading time
by Susanne Saile
LOGFILE No. 34/2018 – Failure Management in a GMP Regulated Environment
04.09.2018
Failure Management in a GMP Regulated Environment
An excerpt from the new GMP Series PDF Download Failure Management in a GMP Regulated Environment
5 minutes reading time
by Martin Mayer
LOGFILE No. 33/2018 – Regulatory Update at the PDA European Annual Meeting
29.08.2018
Regulatory Update at the PDA European Annual Meeting
A report on the PDA European Annual Meeting 2018 – Part 2
6 minutes reading time
by Thomas Peither
LOGFILE No. 32/2018 – Risk Analysis of a Pharmaceutical Water System
22.08.2018
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 No. 31/2018 – Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing
03.08.2018
Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing
An excerpt from the new download Comparison of the EU GMP Guide Annex 1 Sterile Manufacturing
5 minutes reading time
by Fritz Röder
LOGFILE No. 30/2018 – GMP Requirements for Process Validation
26.07.2018
GMP Requirements for Process Validation
An excerpt from the GMP Series PDF Download Inspection of Process Validation
10 minutes reading time
LOGFILE No. 29/2018 – Data Integrity in the Pharmaceutical Industry
23.07.2018
Data Integrity in the Pharmaceutical Industry
14 minutes reading time
by Gary Bird
LOGFILE No. 28/2018 – Executing Sterile Filtration
05.07.2018
Executing Sterile Filtration
An excerpt from the GMP Series download Aseptic Processing of Sterile Medicinal Products
6 minutes reading time
by Ruven Brandes
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