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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 AdviserChapter 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

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