Stay informed!

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

GMP LOGFILE: Lead Article

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

LOGFILE Feature 40/2019 – Batch release process steps

29.10.2019

Batch release process steps

An excerpt from the e-book EU-Compliant Batch Release of Medicinal Products

6 minutes reading time

by Rainer Gnibl, PhD

LOGFILE Feature 39/2019 – Sliding doors in clean rooms – "no go" or "best practice"?

22.10.2019

Sliding doors in clean rooms – "no go" or "best practice"?

A shortened and edited excerpt from the GMP Compliance Adviser, Chapter 3.E

7 minutes reading time

by Harald Flechl / Dr Doris Borchert (editorial editing)

LOGFILE Feature 38/2019 – Is there a legal requirement for the document language of GMP-relevant documents?

15.10.2019

Is there a legal requirement for the document language of GMP-relevant documents? In our company it is planned to write all documents in English. However, many employees do not speak English. Is there a rule that says that the documents must be "readable and understandable" for employees?

Your question - Our answer

4 minutes reading time

by Sabine Rabus

LOGFILE Feature 37/2019 – EDQM inspections and trends of deficiencies relating to API facilities

08.10.2019

EDQM inspections and trends of deficiencies relating to API facilities

10 minutes reading time

by Tim Sandle

LOGFILE Feature 36/2019 – Data integrity in the quality control laboratory

01.10.2019

Data integrity in the quality control laboratory

An excerpt from the GMP Compliance Adviser, Chapter 14.L.1 and the GMP Focus e-book Data Integrity in the EU

5 minutes reading time

by Markus Veit, PhD

LOGFILE Feature 35/2019 – Your E-Learning Trial Version

24.09.2019

Your E-Learning Trial Version

An excerpt from the GMP:READY – GMP for Engineers

2 minutes reading time

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

Do you have any questions?

Contact us:

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