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GMP LOGFILE: Lead Article

LOGFILE Feature 34/2019 – Passive transport packaging

17.09.2019

Passive transport packaging

An excerpt from the GMP Compliance Adviser, Chapter 24.J.3

5 minutes reading time

by Christoph Frick, PhD, and Nicola Spiggelkötter, PhD

LOGFILE Feature 33/2019 – Administration and control of substances

10.09.2019

Administration and control of substances

An excerpt from the new e-book Core Processes in the Pharmaceutical Laboratory

3 minutes reading time

by Markus Limberger, PhD

LOGFILE Feature 32/2019 – GDP - DIN SPEC 91323: Uniform testing standards for vehicles used for the transport of pharmaceuticals

03.09.2019

GDP - DIN SPEC 91323: Uniform testing standards for vehicles used for the transport of pharmaceuticals

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2018

12 minutes reading time

by Sabine Rabus

LOGFILE Feature 31/2019 – Zone concept and clean room classes

27.08.2019

Zone concept and clean room classes

An excerpt from the step-by-step guide GMP Fundamentals

6 minutes reading time

by Christine Oechslein, PhD

LOGFILE Feature 30/2019 – PDA Annual Meeting 2019 – Part 2

06.08.2019

PDA Annual Meeting 2019 – Part 2

10 minutes reading time

by Thomas Peither

LOGFILE Feature 29/2019 – Optimum GMP training concept: modular and inclusive e-learning

30.07.2019

Optimum GMP training concept: modular and inclusive e-learning

8 minutes reading time

by Christine Oechslein, PhD

LOGFILE Feature 28/2019 – PDA Annual Meeting 2019 – Part 1

23.07.2019

PDA Annual Meeting 2019 – Part 1

10 minutes reading time

by Thomas Peither

LOGFILE Feature 27/2019 – Pharmacopoeias in the context of quality control

16.07.2019

Pharmacopoeias in the context of quality control

An excerpt from the GMP Compliance Adviser, Chapter 14.K.2

4 minutes reading time

by Markus Veit, PhD

LOGFILE Feature 26/2019 – GMP and GDP Activities in Storage Areas

09.07.2019

GMP and GDP Activities in Storage Areas

An excerpt from the new e-book Storage of Medicinal Products

4 minutes reading time

by Christian Gausepohl (PhD) and Jürgen Ortlepp

LOGFILE Feature 25/2019 – Management of GMP Projects and New Factory Buildings

02.07.2019

Management of GMP Projects and New Factory Buildings

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2018

8 minutes reading time

by Sabine Paris, PhD

LOGFILE Feature 23/2019 – GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)

18.06.2019

GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)

The screenshots are excerpts from the Online Course GMP:READY – Specialist Knowledge GDP Compact

5 minutes reading time

LOGFILE Feature 22/2019 – Outsourcing: How to Assign a Contract Laboratory

11.06.2019

Outsourcing: How to Assign a Contract Laboratory

An excerpt from the GMP Compliance Adviser, Chapter 17.B.4

5 minutes reading time

by Frank Boettcher, PhD

LOGFILE Feature 21/2019 – The aims and basic principles of the PQS

04.06.2019

The aims and basic principles of the PQS

An excerpt from the new e-book The Road to a Pharmaceutical Quality System

4 minutes reading time

by Stephanie Blum, PhD

LOGFILE Feature 20/2019 – ICH Q12 - Set menu or buffet?

28.05.2019

ICH Q12 - Set menu or buffet?

A Report on the 2019 ISPE Europe Annual Conference

6 minutes reading time

by Sabine Paris, PhD

LOGFILE Feature 19/2019 – GMP training courses in the online offline tension field

21.05.2019

GMP training courses in the online offline tension field

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2018

5 minutes reading time

by Sabine Paris, PhD

LOGFILE Feature 18/2019 – The power of the comma, or: What do print data have to do with drug safety?

14.05.2019

The power of the comma 
Or: What do print data have to do with drug safety?

6 minutes reading time

by Doris Borchert, PhD

LOGFILE 17/2019 – Drive and Leverage Innovation for Pharma

07.05.2019

Drive and Leverage Innovation for Pharma

A Report on the 2019 ISPE Europe Annual Conference

7 minutes reading time

by Sabine Paris, PhD

LOGFILE 16/2019 – How to Manage ICH Q3D Risk Assessments with Change Control Management

30.04.2019

How to Manage ICH Q3D Risk Assessments with Change Control  Management

9 minutes reading time

by Paulino Alonso

LOGFILE 15/2019 – Risk Analysis in the Equipment Life Cycle

23.04.2019

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 14/2019 – The answer is? FDA publishes final data integrity Q&A

16.04.2019

The answer is? FDA publishes final data integrity Q&A

A commentary by Tim Sandle

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