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GMP LOGFILE: Lead Article

LOGFILE Feature 45/2020 – Insufficient cleaning validation

24.11.2020

Insufficient cleaning validation

Shortened excerpt from Chapter 21.C.2.5 of the GMP Compliance Adviser

5 minutes reading time

by Lea Joos

LOGFILE Feature 44/2020 – Can the author of a GMP document also act as its reviewer?

17.11.2020

Can the author of a GMP document also act as its reviewer?

Ask our Experts

3 minutes reading time

LOGFILE Feature 43/2020 – Criticality classifications of deviations

10.11.2020

Criticality classifications of deviations

An approach based on the PIC/S Guidance on Classification of GMP Deficiencies

5 minutes reading time

by Felix Tobias Kern, PhD and Liwa Schneider

LOGFILE Feature 42/2020 – What is the point of "heating" medicinal products to 15–25 °C?

03.11.2020

A case study challenging conventional limits

Excerpt from the GMP Compliance Adviser Chapter 16.F and the GMP Series e-book Storage of Medicinal Products

 

6 minutes reading time

by Christoph Frick, PhD

 

 

LOGFILE Feature 41/2020 – A miss is as good as a mile ...

27.10.2020

Thoughts on the transport of pharmaceuticals from a claims handling perspective

13 minutes reading time

by Axel Radke, Trust Expert Service

LOGFILE Feature 40/2020 – Is COVID-19 THE Long Overdue Wake-up Call for Pharma Supply-Chains?

20.10.2020

Is COVID-19 THE Long Overdue Wake-up Call for Pharma Supply-Chains?

8 minutes reading time

by Hedley Rees

LOGFILE Feature 39/2020 – Regulatory compliance - issue identification

13.10.2020

Regulatory compliance - issue identification

Excerpt from the GMP Compliance Adviser

5 minutes reading time

by Mark Tucker, PhD

LOGFILE Feature 38/2020 – Optimum GMP training concept: modular and inclusive e-learning

06.10.2020

Optimum GMP training concept: modular and inclusive e-learning

8 minutes reading time

by Christine Oechslein, PhD

LOGFILE Feature 37/2020 – ICH Update Quality Initiatives

29.09.2020

ICH Update Quality Initiatives

A report on the lecture by Roger Nosal, Pfizer, 2020 PDA/FDA Joint Regulatory Conference

7 minutes reading time

by Sabine Paris, PhD

LOGFILE Feature 36/2020 – Environmental Monitoring for Non-Sterile Manufacturing: Establishing Where to Sample

22.09.2020

Environmental Monitoring for Non-Sterile Manufacturing: Establishing Where to Sample

Excerpt from the PDA/DHI book Contamination Control in Healthcare Product Manufacturing, Volume 5

5 minutes reading time

by Crystal Booth

LOGFILE Feature 35/2020 – Sliding doors in cleanrooms - "no go" or "best practice"?

16.09.2020

Sliding doors in cleanrooms - "no go" or "best practice"

Shortened and edited excerpt from the GMP Compliance Adviser, Chapter 3.E "Cleanroom Construction Components"

5 minutes reading time

by Harald Flechl / Doris Borchert, PhD (editorial editing)

LOGFILE Feature 33/2020 – Late, but not too late? How to best define the final time point of a stability study?

01.09.2020

Late, but not too late? How to best define the final time point of a stability study?

Ask our Experts

 

5 minutes reading time

 

LOGFILE Feature 32/2020 – How do you organize GMP knowledge and relevant news in your organization?

25.08.2020

How do you organize GMP knowledge and relevant news in your organization?

8 minutes reading time

by Thomas Peither

LOGFILE Feature 31/2020 – Two different pairs of boots: GMP for APIs and GMP for medicinal products

04.08.2020

Two different pairs of boots: GMP for APIs and GMP for medicinal products

Abridged and edited extract from the GMP Compliance Adviser, Chapter 20.A Introduction to "Active Pharmaceutical Ingredients“

 

5 minutes reading time

by Rainer Gnibl, PhD

LOGFILE Feature 30/2020 – Filter integrity test

28.07.2020

Filter integrity test

Excerpt from Chapter 12.E.4.3 Filter integrity test of the GMP Compliance Adviser and GMP Series Aseptic Processing

7 minutes reading time

by Ruven Brandes

LOGFILE Feature 29/2020 – Substance-based medical devices

21.07.2020

Substance-based medical devices

Certainty and challenges due to the new EU Medical Device Regulation

 

5 minutes reading time

by Felix Tobias Kern

LOGFILE Feature 28/2020 – Ask our Experts GMP–compliant documentation: Handling of glued-in printouts

14.07.2020

Ask our Experts GMP–compliant documentation: Handling of glued-in printouts

 

7 minutes reading time

LOGFILE Feature 27/2020 – Work instructions, records and documentation

07.07.2020

Work instructions, records and documentation

An excerpt from the Step-by-Step Guide GMP Fundamentals

 

5 minutes reading time

by Christine Oechslein, PhD

LOGFILE Feature 26/2020 – Hygienic design of pharmaceutical manufacturing processes - example: tablet press

30.06.2020

Hygienic design of pharmaceutical manufacturing processes - example: tablet press

Excerpt from Chapter 4.3 Hygienic Design of the GMP Compliance Adviser

5 minutes reading time

by Richard Denk

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