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GMP LOGFILE: Lead Article

LOGFILE No. 05/2019 – GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment

05.02.2019

GMP Supplier Assessment Questionnaire – Personnel, Premises and Equipment

Excerpt from the GMP Series Download GMP Supplier Assessment Questionnaire

4 minutes reading time

by Cornelia Wawretschek

LOGFILE No. 04/2019 – DT When and how must OOS examinations be triggered?

29.01.2019

When and how must OOS examinations be triggered?

Your question - Our answer

6 minutes reading time

by Doris Borchert, PhD

 

LOGFILE No. 03/2019 – Microbiological Monitoring: Actions when levels are exceeded

22.01.2019

Microbiological Monitoring: Actions when levels are exceeded

Excerpt from the GMP Compliance AdviserChapter 10.E

5 minutes reading time

by Hanfried Seyfarth, PhD

LOGFILE No. 02/2019 – Who may carry out the sampling?

08.01.2019

Who may carry out the sampling?

Ask our experts

5 minutes reading time

by Doris Borchert, PhD

 

LOGFILE No. 01/2019 – Agency Expectations: Design Qualification

04.12.2018

Qualification and Validation: Agency Expectations – Design Qualification (DQ)

Excerpt from the GMP Series Download Qualification and Validation: Agency Expectations

5 minutes reading time

by Michael Hiob, PhD

LOGFILE No. 46/2018 – Product Transfer Challenges

27.11.2018

Product Transfer Challenges

An excerpt from the GMP Series Download A Successful Concept for Technology Transfer in Drug Manufacturing

4 minutes reading time

by Christian Gausepohl, PhD

LOGFILE No. 45/2018 – GDP Questionnaire – Incoming goods

13.11.2018

GDP Questionnaire – Incoming goods

An excerpt from the GDP Questionnaire

5 minutes reading time

by Simone Ferrante

LOGFILE No. 44/2018 – What is quality management?

06.11.2018

What is quality management?

An excerpt from the GMP Fundamentals

5 minutes reading time

by Christine Oechslein, PhD

 

LOGFILE No. 42/2018 – The Structure of Electronic Document Management and Quality Management Systems (EDMS/EQMS)

30.10.2018

The Structure of Electronic Document Management and Quality Management Systems (EDMS/EQMS)

An excerpt from the GMP Compliance AdviserChapter 1.H.2

5 minutes reading time

by Thilo Gukelberger

LOGFILE No. 43/2018 – Paradigm shift in the establishment of limits for the validation of cleaning processes

30.10.2018

Paradigm shift in the establishment of limits for the validation of cleaning processes

An excerpt from the GMP Series Download A Pharma Guide to Cleaning Validation

5 minutes reading time

by Jens Hrach, PhD

LOGFILE No. 41/2018 – Inspection of Process Validation

23.10.2018

Inspection of Process Validation

An excerpt from the new GMP Series Download Inspection of Process Validation

6 minutes reading time

 

 

LOGFILE No. 40/2018 – Ventilation units, or the invisible energy in the clean room

16.10.2018

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 No. 39/2018 – Batch release process steps

09.10.2018

Batch release process steps

An excerpt from the new GMP Series PDF Download EU-Compliant Batch Release of Medicinal Products

6 minutes reading time

by Rainer Gnibl, PhD

LOGFILE No. 38/2018 – Blockchain: Will it Transform the Pharmaceutical Supply Chain?

09.10.2018

Blockchain: Will it Transform the Pharmaceutical Supply Chain?

6 minutes reading time

by Mark Crawford

LOGFILE No. 37/2018 – What is the point of "heating" medicinal products to 15–25 °C?

25.09.2018

What is the point of "heating" medicinal products to 15–25 °C?

A case study challenging conventional limits

An excerpt from the GMP Compliance AdviserChapter 24.F

6 minutes reading time

by Christoph Frick, PhD

LOGFILE No. 36/2018 – Calibration of Laboratory Instruments

20.09.2018

Calibration of Laboratory Instruments

An excerpt from the new GMP Series PDF Download Qualification and Calibration of Laboratory Instruments in Pharmaproduction

5 minutes reading time

by Josef Künzle, PhD

LOGFILE No. 35/2018 – Quality Oversight and Lean QA

13.09.2018

Quality Oversight and Lean QA

A Summary of the GMP DIALOGUE at the GMP-BERATER Tage 2017

6 minutes reading time

by Susanne Saile

 

LOGFILE No. 34/2018 – Failure Management in a GMP Regulated Environment

04.09.2018

Failure Management in a GMP Regulated Environment

An excerpt from the new GMP Series PDF Download Failure Management in a GMP Regulated Environment

5 minutes reading time

by Martin Mayer

LOGFILE No. 33/2018 – Regulatory Update at the PDA European Annual Meeting

29.08.2018

Regulatory Update at the PDA European Annual Meeting

A report on the PDA European Annual Meeting 2018 – Part 2

6 minutes reading time

by Thomas Peither

LOGFILE No. 32/2018 – Risk Analysis of a Pharmaceutical Water System

22.08.2018

Risk Analysis of a Pharmaceutical Water System

An excerpt from the GMP Series PDF Download Qualification of Pharma Water Supply Systems

5 minutes reading time

by Fritz Röder

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