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GMP LOGFILE: Lead Article

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

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

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