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GMP LOGFILE: Lead Article

LOGFILE No. 07/2018 – What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 1

21.02.2018

What's new in the draft of Annex 1 of the EU GMP Guidelines? – Part 1

6 minutes reading time

A commentary by Ruven Brandes and Fritz Röder

LOGFILE No. 05/2018 – Implementing and Monitoring Data Integrity Measures

06.02.2018

Implementing and Monitoring Data Integrity Measures

An excerpt from the GMP Focus PDF Download Data Integrity in the EU

5 minutes reading time

by Markus Veit, PhD

LOGFILE No. 04/2018 – Key learnings from serialisation projects – Part 2

30.01.2018

Key learnings from serialisation projects – Part 2

6 minutes reading time

by Andrew Love and Stephen McIndoe

LOGFILE No. 03/2018 – Key learnings from serialisation projects – Part 1

23.01.2018

Key learnings from serialisation projects – Part 1

6 minutes reading time

by Andrew Love and Stephen McIndoe

 

 

LOGFILE No. 02/2018 – Risk Analysis in the Equipment Life Cycle

16.01.2018

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 No. 06/2018 – Root Cause Analysis – An Essential Enabler

12.01.2018

Root Cause Analysis – An Essential Enabler

An excerpt from the GMP Compliance Adviser, Chapter 20.E Failure Management

8 minutes reading time

by Martin Mayer

LOGFILE No. 01/2018 – Ask Our Experts – Part 2 – 4 GMP-Questions which might be of your interest

09.01.2018

Ask Our Experts – Part 2

4 GMP-Questions which might be of your interest

7 minutes reading time

by Sabine Rabus

LOGFILE No. 46/2017 – International GMP – Six Questions for Jacques Morénas

05.12.2017

International GMP – Six Questions for Jacques Morénas

5 minutes reading time

LOGFILE No. 44/2017 – Intermediate Bulk Container Systems

21.11.2017

Intermediate Bulk Container Systems

An excerpt from the GMP Series PDF Download Technical Solutions for Personal Protection in Solid Drug Manufacturing

5 minutes reading time

by Richard Denk

LOGFILE No. 43/2017 – Indispendsable: The Determination of PDE Values as Exposure Limits

14.11.2017

Indispensable: The Determination of PDE Values as Exposure Limits for Risk Analysis in Shared Facilities

It is not possible to estimate the danger or toxicity of APIs only according to their therapeutic group.
Results of an analysis of 1200 active substances.

8 minutes reading time

by Beatriz Carrero, PhD, Azierta and Sabine Paris, PhD, Maas & Peither – GMP Publishing

LOGFILE No. 42/2017 – Final version of the EMA Q&A paper on WFI production without distillation

10.11.2017

Update: Final version of the EMA Q&A paper on WFI production without distillation

5 minutes reading time

by Fritz Röder

LOGFILE No. 41/2017 – Deviation Management

31.10.2017

Deviations – Definition and Requirements

An excerpt from GMP Series Implementing a World Class Deviation Management

By Dr. Christian Gausepohl

LOGFILE No. 40/2017 – Calibration of laboratory instruments

24.10.2017

Calibration of laboratory instruments

An excerpt of the GMP Compliance AdviserChapter 14.D.4

5 minutes reading time

by Josef Künzle, PhD, Wolfgang Nedvidek, PhD

LOGFILE No. 47/2017 – Ask Our Experts – Part 1 – 6 GMP-Questions which might be of interest to You

24.10.2017

Ask Our Experts – Part 1

6 GMP-Questions which might be of interest to you

7 minutes reading time

by Sabine Rabus

LOGFILE No. 39/2017 – Mobile water treatment possible even in the GMP area for the first time!

17.10.2017

Mobile water treatment possible even in the GMP area for the first time!

6 minutes reading time

by Fritz Röder

LOGFILE No. 45/2017 – 8 Golden Rules for Personnel Hygiene

16.10.2017

8 Golden Rules for Personnel Hygiene

An excerpt from the GMP Compliance AdviserChapter 11.B.5

4 minutes reading time

by Christian Gausepohl, PhD

LOGFILE No. 38/2017 – MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 2

10.10.2017

MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 2

6 minutes reading time

by Dr. Tim Sandle

LOGFILE No. 37/2017 – Physical monitoring of cleanrooms

04.10.2017

Physical monitoring of cleanrooms

An excerpt from GMP Series Monitoring of HVAC Systems in GMP Environments

by Dr. Hans H. Schicht

LOGFILE No. 36/2017 – MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 1

26.09.2017

MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 1

6 minutes reading time

by Dr. Tim Sandle

LOGFILE No. 35/2017 – Technology Transfer Phases

19.09.2017

Technology Transfer Phases

An excerpt from GMP Series A Successful Concept for Technology Transfer in Drug Manufacturing

5 minutes reading time

by Christian Gausepohl, PhD

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