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GMP LOGFILE: Lead Article

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

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

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