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GMP LOGFILE: Lead Article

LOGFILE Feature 03/2021 – 26th PTS GMP Conference – Current Topics Presented Virtually

26.01.2021

26th PTS GMP Conference - Current Topics Presented Virtually

12 minutes reading time

by Doris Borchert, PhD

LOGFILE Feature 01/2021 – Digitalised Crisis Response for Pharmaceutical Production

04.01.2021

Digitalised Crisis Response for Pharmaceutical Production

9 minutes reading time

by Felix Michler

LOGFILE Feature 48/2020 – Online packaging line controls

15.12.2020

Online packaging line controls

Excerpt from the GMP Compliance Adviser, Chapter 13.B.6.2

6 minutes reading time

by Vera Werner

LOGFILE Feature 47/2020 – Brief spots on autumn conferences

08.12.2020

Brief spots on autumn conferences

PDA and ISPE offered virtual conferences with interesting insights in September 2020

5 minutes reading time

by Thomas Peither

LOGFILE Feature 46/2020 – Certification of products manufactured outside the EU

01.12.2020

Certification of products manufactured outside the EU


Excerpt from the GMP Compliance Adviser Chapter 14.J and the GMP Series e-book EU-Compliant Batch Release of Medicinal Products
 

6 minutes reading time

by Rainer Gnibl, PhD

LOGFILE Feature 45/2020 – Insufficient cleaning validation

24.11.2020

Insufficient cleaning validation

Shortened excerpt from Chapter 21.C.2.5 of the GMP Compliance Adviser

5 minutes reading time

by Lea Joos

LOGFILE Feature 44/2020 – Can the author of a GMP document also act as its reviewer?

17.11.2020

Can the author of a GMP document also act as its reviewer?

Ask our Experts

3 minutes reading time

LOGFILE Feature 43/2020 – Criticality classifications of deviations

10.11.2020

Criticality classifications of deviations

An approach based on the PIC/S Guidance on Classification of GMP Deficiencies

5 minutes reading time

by Felix Tobias Kern, PhD and Liwa Schneider

LOGFILE Feature 42/2020 – What is the point of "heating" medicinal products to 15–25 °C?

03.11.2020

A case study challenging conventional limits

Excerpt from the GMP Compliance Adviser Chapter 16.F and the GMP Series e-book Storage of Medicinal Products

 

6 minutes reading time

by Christoph Frick, PhD

 

 

LOGFILE Feature 41/2020 – A miss is as good as a mile ...

27.10.2020

Thoughts on the transport of pharmaceuticals from a claims handling perspective

13 minutes reading time

by Axel Radke, Trust Expert Service

LOGFILE Feature 40/2020 – Is COVID-19 THE Long Overdue Wake-up Call for Pharma Supply-Chains?

20.10.2020

Is COVID-19 THE Long Overdue Wake-up Call for Pharma Supply-Chains?

8 minutes reading time

by Hedley Rees

LOGFILE Feature 39/2020 – Regulatory compliance - issue identification

13.10.2020

Regulatory compliance - issue identification

Excerpt from the GMP Compliance Adviser

5 minutes reading time

by Mark Tucker, PhD

LOGFILE Feature 38/2020 – Optimum GMP training concept: modular and inclusive e-learning

06.10.2020

Optimum GMP training concept: modular and inclusive e-learning

8 minutes reading time

by Christine Oechslein, PhD

LOGFILE Feature 37/2020 – ICH Update Quality Initiatives

29.09.2020

ICH Update Quality Initiatives

A report on the lecture by Roger Nosal, Pfizer, 2020 PDA/FDA Joint Regulatory Conference

7 minutes reading time

by Sabine Paris, PhD

LOGFILE Feature 36/2020 – Environmental Monitoring for Non-Sterile Manufacturing: Establishing Where to Sample

22.09.2020

Environmental Monitoring for Non-Sterile Manufacturing: Establishing Where to Sample

Excerpt from the PDA/DHI book Contamination Control in Healthcare Product Manufacturing, Volume 5

5 minutes reading time

by Crystal Booth

LOGFILE Feature 35/2020 – Sliding doors in cleanrooms - "no go" or "best practice"?

16.09.2020

Sliding doors in cleanrooms - "no go" or "best practice"

Shortened and edited excerpt from the GMP Compliance Adviser, Chapter 3.E "Cleanroom Construction Components"

5 minutes reading time

by Harald Flechl / Doris Borchert, PhD (editorial editing)

LOGFILE Feature 33/2020 – Late, but not too late? How to best define the final time point of a stability study?

01.09.2020

Late, but not too late? How to best define the final time point of a stability study?

Ask our Experts

 

5 minutes reading time

 

LOGFILE Feature 32/2020 – How do you organize GMP knowledge and relevant news in your organization?

25.08.2020

How do you organize GMP knowledge and relevant news in your organization?

8 minutes reading time

by Thomas Peither

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