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GMP LOGFILE: Lead Article

LOGFILE 14/2019 – The answer is? FDA publishes final data integrity Q&A

16.04.2019

The answer is? FDA publishes final data integrity Q&A

A commentary by Tim Sandle

LOGFILE 13/2019 – Calibration of Laboratory Instruments

09.04.2019

Calibration of Laboratory Instruments

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

5 minutes reading time

by Josef Künzle, PhD

LOGFILE 12/2019 – Clean air in non-sterile production areas

02.04.2019

Clean air in non-sterile production areas

Results of an online survey

8 minutes reading time

by Doris Borchert, PhD

LOGFILE 11/2019 – Risk Analysis of a Pharmaceutical Water System

27.03.2019

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

LOGFILE 10/2019 – Areas of Application for E-Learning and Advantages of E-Learning

19.03.2019

Areas of Application for E-Learning and Advantages of E-Learning

4 minutes reading time

by Christine Oechslein, PhD

LOGFILE 09/2019 – Is monitoring (of germs and particles) required in “unclean airlock areas” for non-sterile production?

12.03.2019

Is monitoring (of germs and particles) required in “unclean airlock areas” for non-sterile production?

Ask our experts

5 minutes reading time

by Doris Borchert, PhD

LOGFILE 08/2019 – New Technologies for Cleanroom Planning

05.03.2019

New Technologies for Cleanroom Planning

Excerpt from the GMP Compliance Adviser, Chapter 3.E.4

4 minutes reading time

by Harald Flechl, Senior Engineer

LOGFILE 07/2019 – Annex 1 - Sterile and Aseptic Production Facing New Challenges

26.02.2019

Annex 1 - Sterile and Aseptic Production Facing New Challenges

A Summary of the GMP DIALOGUE at the GMP-BERATER Tage 2018

8 min. reading time

by Dr Sabine Paris

LOGFILE 06/2019 – The GMP Regulations Report 2018

19.02.2019

The GMP Regulations Report 2018

by Sabine Rabus

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

 

 

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