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GMP LOGFILE: Lead Article

LOGFILE Feature 08/2021 – 3 Systems for Cleanroom Walls

02.03.2021

LOGFILE Feature 08/2021 – 3 Systems for Cleanroom Walls

Excerpt form the GMP Compliance Adviser, Chapter 3.E Cleanroom construction components

8 minutes reading time

by Harald Flechl

LOGFILE Feature 07/2021 – EMA Guideline on the Quality of Water for Pharmaceutical Use

23.02.2021

EMA Guideline on the Quality of Water for Pharmaceutical Use

12 minutes reading time

by Tim Sandle, PhD

Water for Pharmaceutical Use

LOGFILE Feature 06/2021 – Insight at Second Glance - The Human Error and its Root Causes

16.02.2021

Insight at Second Glance - The Human Error and its Root Causes

Excerpt from the GMP Compliance Adviser, chapter 1.E Deviation Management

10 minutes reading time

by Doris Borchert, PhD and Christian Gausepohl, PhD

 

 

LOGFILE Feature 05/2021 – 2 Approaches for Implementing ICH Q3D

09.02.2021

2 Approaches for Implementing ICH Q3D

Excerpt from the GMP Compliance Adviser Chapter 14.N Elemental impurities

10 minutes reading time

by Paulino Alonso, PhD

LOGFILE Feature 04/2021 – TOP 15 Countdown: "Question of the Week"

02.02.2021

TOP 15 Countdown: “Question of the Week”

10 minutes reading time

LOGFILE Feature 03/2021 – 26th PTS GMP Conference – Current Topics Presented Virtually

26.01.2021

26th PTS GMP Conference - Current Topics Presented Virtually

12 minutes reading time

by Doris Borchert, PhD

LOGFILE Feature 01/2021 – Digitalised Crisis Response for Pharmaceutical Production

04.01.2021

Digitalised Crisis Response for Pharmaceutical Production

9 minutes reading time

by Felix Michler

LOGFILE Feature 48/2020 – Online packaging line controls

15.12.2020

Online packaging line controls

Excerpt from the GMP Compliance Adviser, Chapter 13.B.6.2

6 minutes reading time

by Vera Werner

LOGFILE Feature 47/2020 – Brief spots on autumn conferences

08.12.2020

Brief spots on autumn conferences

PDA and ISPE offered virtual conferences with interesting insights in September 2020

5 minutes reading time

by Thomas Peither

LOGFILE Feature 46/2020 – Certification of products manufactured outside the EU

01.12.2020

Certification of products manufactured outside the EU


Excerpt from the GMP Compliance Adviser Chapter 14.J and the GMP Series e-book EU-Compliant Batch Release of Medicinal Products
 

6 minutes reading time

by Rainer Gnibl, PhD

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

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