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GMP LOGFILE: Lead Article

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

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

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