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GMP LOGFILE: Lead Article

LOGFILE No. 38/2017 – MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 2

10.10.2017

MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 2

6 minutes reading time

by Dr. Tim Sandle

LOGFILE No. 37/2017 – Physical monitoring of cleanrooms

04.10.2017

Physical monitoring of cleanrooms

An excerpt from GMP Series Monitoring of HVAC Systems in GMP Environments

by Dr. Hans H. Schicht

LOGFILE No. 36/2017 – MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 1

26.09.2017

MHRA Annual Deficiency Review Highlights Sterility Assurance Issues – Part 1

6 minutes reading time

by Dr. Tim Sandle

LOGFILE No. 35/2017 – Technology Transfer Phases

19.09.2017

Technology Transfer Phases

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

5 minutes reading time

by Christian Gausepohl, PhD

LOGFILE No. 34/2017 – Data Integrity – Old Wine in New Skins? – Part 2

12.09.2017

Data Integrity – Old Wine in New Skins?

GMP Talk Between the GMP Inspector Dr. Petra Rempe and Thomas Peither – Part 2

7 minutes reading time

by Sabine Paris, PhD

LOGFILE No. 33/2017 – Data Integrity – Old Wine in New Skins? – Part 1

05.09.2017

Data Integrity – Old Wine in New Skins?

GMP-Talk Between GMP Inspector Dr. Petra Rempe and Thomas Peither – Part 1

7 minutes reading time

by Sabine Paris, PhD

LOGFILE No. 32/2017 – Human Resource Management

29.08.2017

Human Resource Management: Qualification requirements and requirement profiles

An Excerpt from the GMP Series PDF Download Roadmap to Manage Personnel in Pharmaceutical Manufacturing

by Michael Hiob, PhD

LOGFILE No. 30/2017 – MRA-EU-USA – Part 2

01.08.2017

What you can expect from the newly amended MRA between the EU and the USA – Facts and figures in the GMP Sector – Part 2

5 minutes reading time

by Sabine Paris, PhD

LOGFILE No. 29/2017 – MRA-EU-USA – Part 1

25.07.2017

What you can expect from the newly amended MRA between the EU and the USA – Facts and figures in the GMP Sector – Part 1

5 minutes reading time

by Sabine Paris, PhD

LOGFILE No. 28/2017 – Checklist Performance Qualification

18.07.2017

Checklist Performance Qualification

An Excerpt from the GMP Series PDF Download The Ultimate Checklist for Premises and HVAC Qualification

by Hans H. Schicht, PhD

LOGFILE Nr. 27/2017 – Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

07.07.2017

Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

A report on the ISPE 2017 Europe Annual Conference

6 minutes reading time

by Sabine Paris, PhD

LOGFILE No. 25/2017 – Manufacturing Innovation – PDA Annual Meeting 2017, Anaheim

27.06.2017

Manufacturing Innovation - PDA Annual Meeting 2017, Anaheim

8 min. reading time

by Thomas Peither

LOGFILE No. 31/2017 – GMP-Compliance-Index 2017

19.06.2017

GMP-Compliance-Index 2017

Join in now and further your knowledge!

by Thomas Peither

LOGFILE No. 23/2017 – Changes in USP <1231>: Water for Pharmaceutical Purposes

13.06.2017

Changes in USP <1231>: Water for Pharmaceutical Purposes

8 min. reading time

by Fritz Röder

LOGFILE No. 21/2017 – Quality Agreement – A Sample Document

31.05.2017

Quality Agreement – A Sample Document

An excerpt from the GMP Series Quality Agreement

by Dr. Christine Oechslein

 

 

 

LOGFILE No. 21/2017 – Quality Agreement – A Sample Document

30.05.2017

Quality Agreement – A Sample Document

An excerpt from the GMP Series Quality Agreement

by Dr. Christine Oechslein

LOGFILE No. 20/2017 – 85 Questions You Should Ask Your Contract Manufacturer / Contract Lab

23.05.2017

85 Questions You Should Ask Your Contract Manufacturer / Contract Lab

An excerpt from the GMP Series GMP-Questionnaire: Contract Manufacturing / Contract Analysis

by Dr. Christine Oechslein

LOGFILE No. 19/2017 – Complex Product and Process Flows

16.05.2017

A Challenge: Complex Product and Process Flows

An excerpt from the GMP Compliance Adviser (formerly GMP MANUAL), Chapter 14.J.8 and 14.J.8.1

3 min. reading time

by Rainer Gnibl

LOGFILE No. 27/2017 – Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

12.05.2017

Future Trends of Pharmaceutical Manufacturing revealed in Barcelona

A report on the ISPE 2017 Europe Annual Conference

6 minutes reading time

by Sabine Paris, PhD

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