Stay informed!

Register now for the free GMP newsletter LOGFILE
and don't miss any news.

GMP LOGFILE: Lead Article

LOGFILE Feature 14/2020 –The QP should decide or "lessons learned"

08.04.2020

The QP should decide or "lessons learned"

A GMP dialogue of the GMP conference, the GMP BERATER Tage, in October 2019 was entitled "The QP should decide or lessons learned". The participants brought along concrete questions, the experts gave clear answers. A lively exchange developed, during which the participants also reported in detail on their experiences. We have summarised the most important results for you in this protocol.

7 minutes reading time

LOGFILE Feature 13/2020 – GMP training courses in the online offline tension field

01.04.2020

GMP training courses in the online offline tension field

 

7 minutes reading time

by Sabine Paris, PhD

LOGFILE Feature 12/2020 –The power of the comma Or: What do print data have to do with drug safety?

24.03.2020

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

5 minutes reading time

 

by Doris Borchert, PhD

LOGFILE Feature 11/2020 –Questions about manufacturing technology

18.03.2020

Questions about manufacturing technology

7 minutes reading time

by Doris Borchert, PhD

LOGFILE Feature 10/2020 – Trust is good, calibration is better!

10.03.2020

Trust is good, calibration is better!

Shortened excerpt from the GMP Compliance Adviser, Chapter 4.F Calibration

 

11 minutes reading time

by Hansjörg Gutmann, Markus Kopf, Markus Salemink, Dr. Christian Sander

LOGFILE Feature 09/2020 – The GMP Regulations Report 2019

04.03.2020

The GMP Regulations Report 2019

At a glance and always at hand – the most relevant regulatory developments of 2019.

15 minutes reading time

by Sabine Rabus

LOGFILE Feature 08/2020 – 7 Basic GMP Questions and Answers

26.02.2020

7 Basic GMP Questions and Answers

A GMP dialogue of the GMP conference, the GMP BERATER Tage, in October 2019 was entitled "Basic GMP questions and answers". Here, the questions could be asked to which the participants always wanted to have an answer. The two experts provided answers in the course of a lively discussion.

Experts: GMP Inspector Petra Rempe, PhD, Josef Künzle, PhD, Head of Global Quality Management at Basilea

Protocol: Sabine Paris, PhD

LOGFILE Feature 07/2020 – MHRA: Feedback from GMP inspections

18.02.2020

MHRA: Feedback from GMP inspections

15 minutes reading time

by Tim Sandle

 

LOGFILE Feature 06/2020 – Packaging material testing

11.02.2020

Packaging material testing

An excerpt from the new e-book GMP Series Packaging Materials for Pharmaceutical Products

 

5 minutes reading time
by André Deister, Sabine Mendel

LOGFILE Feature 05/2020 – TOP 15 Countdown: “Question of the Week”

04.02.2020

TOP 15 Countdown: “Question of the Week”

LOGFILE Feature 04/2020 – Microbiological monitoring in non-sterile areas

28.01.2020

Microbiological monitoring in non-sterile areas

A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2019

7 minutes reading time

by Doris Borchert, PhD

LOGFILE Feature 03/2020 – Selection and procurement of cleanroom construction components

22.01.2020

Selection and procurement of cleanroom construction components

An excerpt from the new e-book A Pharma Guide to Planning and Constructing Cleanrooms

5 minutes reading time

by André Deister, Sabine Mendel

LOGFILE Feature 02/2020 – GDP inspections: How to avoid defects

14.01.2020

GDP inspections: How to avoid defects

Interview with Lea Joos, GMP inspector and author of the new GMP Compliance Adviser Chapter 16.S.2 "GDP inspections: frequent deficiencies in the qualification of logistics service providers and how to avoid them"

7 minutes reading time

by Lea Joos and Doris Borchert

LOGFILE Feature 01/2020 – Your question – our answer: Environmental Monitoring

07.01.2020

Your question – our answer

Question about environmental monitoring

7 minutes reading time

LOGFILE Feature 46/2019 – Failure Management in a GMP Regulated Environment

10.12.2019

Failure Management in a GMP Regulated Environment

An excerpt from the GMP Series e-book Failure Management in a GMP Regulated Environment

5 minutes reading time

by Martin Mayer

LOGFILE Feature 45/2019 – Ventilation units, or the invisible energy in the clean room

03.12.2019

Ventilation units, or the invisible energy in the clean room

GMP-Talk with Harald Flechl at the LOUNGES 2018 in Karlsruhe

9 minutes reading time

by Doris Borchert, PhD

LOGFILE Feature 44/2019 – PDA/FDA Joint Regulatory Conference 2019

26.11.2019

PDA/FDA Joint Regulatory Conference 2019

6 minutes reading time

by Thomas Peither

LOGFILE Feature 43/2019 – Transfer of analytical procedures to the contract laboratory

19.11.2019

Transfer of analytical procedures to the contract laboratory

An excerpt from the e-book Managing Contract Manufacturers and Testing Labs and the online knowledge portal GMP Compliance Adviser

4 minutes reading time

by Frank Böttcher, PhD

LOGFILE Feature 42/2019 – In 8 steps to self-learning FMEA

12.11.2019

In 8 steps to self-learning FMEA

The alternative to the classic FMEA: FMEA according to Spengler and Juhnke

6 minutes reading time

by Felix Tobias Kern, PhD

LOGFILE Feature 41/2019 – New Toxicological Assessment Services of GMP Publishing

05.11.2019

New Toxicological Assessment Services of GMP Publishing:

Organic and Mutagenic Impurities / Environmental Risk Assessments (ERAs)

10 minutes reading time

by Sabine Paris, PhD

Do you have any questions?

Contact us:

Phone +49 7622 66686-70
E-mail: service@gmp-publishing.com