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GMP LOGFILE: Lead Article

LOGFILE Feature 23/2019 – GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)

18.06.2019

GMP:READY - Specialist Knowledge GDP Compact (Bundle 11 A+B)

The screenshots are excerpts from the Online Course GMP:READY – Specialist Knowledge GDP Compact

5 minutes reading time

LOGFILE Feature 22/2019 – Outsourcing: How to Assign a Contract Laboratory

11.06.2019

Outsourcing: How to Assign a Contract Laboratory

An excerpt from the GMP Compliance Adviser, Chapter 17.B.4

5 minutes reading time

by Frank Boettcher, PhD

LOGFILE Feature 21/2019 – The aims and basic principles of the PQS

04.06.2019

The aims and basic principles of the PQS

An excerpt from the new e-book The Road to a Pharmaceutical Quality System

4 minutes reading time

by Stephanie Blum, PhD

LOGFILE Feature 20/2019 – ICH Q12 - Set menu or buffet?

28.05.2019

ICH Q12 - Set menu or buffet?

A Report on the 2019 ISPE Europe Annual Conference

6 minutes reading time

by Sabine Paris, PhD

LOGFILE Feature 19/2019 – GMP training courses in the online offline tension field

21.05.2019

GMP training courses in the online offline tension field

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

5 minutes reading time

by Sabine Paris, PhD

LOGFILE Feature 18/2019 – The power of the comma, or: What do print data have to do with drug safety?

14.05.2019

The power of the comma 
Or: What do print data have to do with drug safety?

6 minutes reading time

by Doris Borchert, PhD

LOGFILE 17/2019 – Drive and Leverage Innovation for Pharma

07.05.2019

Drive and Leverage Innovation for Pharma

A Report on the 2019 ISPE Europe Annual Conference

7 minutes reading time

by Sabine Paris, PhD

LOGFILE 16/2019 – How to Manage ICH Q3D Risk Assessments with Change Control Management

30.04.2019

How to Manage ICH Q3D Risk Assessments with Change Control  Management

9 minutes reading time

by Paulino Alonso

LOGFILE 15/2019 – Risk Analysis in the Equipment Life Cycle

23.04.2019

Risk Analysis in the Equipment Life Cycle

An excerpt from the GMP Focus PDF Download Principles of Equipment Qualification

5 minutes reading time

by Ulrike Reuter

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

 

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