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GMP LOGFILE: Lead Article

LOGFILE Feature 27/2020 – Work instructions, records and documentation

07.07.2020

Work instructions, records and documentation

An excerpt from the Step-by-Step Guide GMP Fundamentals

 

5 minutes reading time

by Christine Oechslein, PhD

LOGFILE Feature 26/2020 – Hygienic design of pharmaceutical manufacturing processes - example: tablet press

30.06.2020

Hygienic design of pharmaceutical manufacturing processes - example: tablet press

Excerpt from Chapter 4.3 Hygienic Design of the GMP Compliance Adviser

5 minutes reading time

by Richard Denk

LOGFILE Feature 25/2020 – GMP:READY: GMP for Engineers

23.06.2020

GMP:READY: GMP for Engineers

GMP Training: Simple and Online 24/7

5 minutes reading time

LOGFILE Feature 24/2020 – Ask Our Experts – Validity period of FDA Certificates of Conformity?

16.06.2020

Ask Our Experts – Validity period of FDA Certificates of Conformity?

 

7 minutes reading time

LOGFILE Feature 23/2020 – FMD alerts in 2020 – where we are a year into legislation

09.06.2020

FMD alerts in 2020 – where we are a year into legislation

 

9 minutes reading time

by Grant Courtney

LOGFILE Feature 22/2020 – Environmental Risk Assessment: ERA Reports

02.06.2020

Environmental Risk Assessment: ERA Reports

Excerpt from our Guideline Evaluation of the environmental risks of medicinal products: ERA reports

8 minutes reading time

LOGFILE Feature 21/2020 – Purpose and content of a management review

26.05.2020

Purpose and content of a management review

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

5 minutes reading time

by Stephanie Blum

LOGFILE Feature 20/2020 – Challenges lurking in manufacturing

19.05.2020

Challenges lurking in manufacturing

A GMP-DIALOGUE of our GMP conference, the GMP-BERATER-Days, in October 2019 revolved around the topic "Challenges lurking in manufacturing". Questions on the topic were asked by participants and answered by the experts in a lively discussion.

 

Experts:            GMP inspector Lea Joos, Christian Gausepohl, PhD, QP and Head of Quality Unit

Protocol:           Sabine Paris, PhD

LOGFILE Feature 19/2020 – 12 FREQUENTLY ASKED QUESTIONS on SOPs

12.05.2020

12 FREQUENTLY ASKED QUESTIONS on SOPs

This text is an excerpt from the DHI/PDA Book SOPs Clear and Simple: For Healthcare Manufacturers

7 minutes reading time

by By Brian Matye, Jeanne Moldenhauer, Susan Schniepp

 

LOGFILE Feature 18/2020 – Nothing ventured, nothing gained

05.05.2020

Nothing ventured, nothing gained

- On dealing with risks in the manufacture of medicinal products

An excerpt from the GMP Compliance Adviser, Chapters 19.A Agency expectations of quality risk management and 19.B Application and benefits of QRM in the pharmaceutical industry

LOGFILE Feature 17/2020 – Disruptive technologies in the production of pharmaceuticals

28.04.2020

Disruptive technologies in the production of pharmaceuticals

A GMP-DIALOGUE of the GMP Conference, the GMP-BERATER Tage, in October 2019 revolved around the topic "Disruptive technologies in the production of pharmaceuticals". The participants asked questions about the topic, which the two experts answered in an exciting discussion.

8 Min. Lesezeit

Experts:                Martin Düblin, One One Eleven GmbH and GMP inspector Rainer Gnibl (PhD)

Moderation:         Barbara Peither

Protocol:               Nadja Schaubhut

LOGFILE Feature 16/2020 –Batch Designation: Handwritten or Electronic?

21.04.2020

Batch Designation: Handwritten or Electronic?

Ask our Experts

5 minutes reading time

by Doris Borchert

LOGFILE Feature 15/2020 – Acceptance testing or qualification?

15.04.2020

Acceptance testing or qualification?

Shortened excerpt from the GMP Compliance Adviser, "Chapter 3.J Qualification of premises and air handling technology"

7 minutes reading time

by Harald Flechl

 

LOGFILE Feature 14/2020 –The QP should decide or "lessons learned"

08.04.2020

The QP should decide or "lessons learned"

A GMP dialogue of the GMP conference, the GMP BERATER Tage, in October 2019 was entitled "The QP should decide or lessons learned". The participants brought along concrete questions, the experts gave clear answers. A lively exchange developed, during which the participants also reported in detail on their experiences. We have summarised the most important results for you in this protocol.

7 minutes reading time

LOGFILE Feature 13/2020 – GMP training courses in the online offline tension field

01.04.2020

GMP training courses in the online offline tension field

 

7 minutes reading time

by Sabine Paris, PhD

LOGFILE Feature 12/2020 –The power of the comma Or: What do print data have to do with drug safety?

24.03.2020

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

5 minutes reading time

 

by Doris Borchert, PhD

LOGFILE Feature 11/2020 –Questions about manufacturing technology

18.03.2020

Questions about manufacturing technology

7 minutes reading time

by Doris Borchert, PhD

LOGFILE Feature 10/2020 – Trust is good, calibration is better!

10.03.2020

Trust is good, calibration is better!

Shortened excerpt from the GMP Compliance Adviser, Chapter 4.F Calibration

 

11 minutes reading time

by Hansjörg Gutmann, Markus Kopf, Markus Salemink, Dr. Christian Sander

LOGFILE Feature 09/2020 – The GMP Regulations Report 2019

04.03.2020

The GMP Regulations Report 2019

At a glance and always at hand – the most relevant regulatory developments of 2019.

15 minutes reading time

by Sabine Rabus

LOGFILE Feature 08/2020 – 7 Basic GMP Questions and Answers

26.02.2020

7 Basic GMP Questions and Answers

A GMP dialogue of the GMP conference, the GMP BERATER Tage, in October 2019 was entitled "Basic GMP questions and answers". Here, the questions could be asked to which the participants always wanted to have an answer. The two experts provided answers in the course of a lively discussion.

Experts: GMP Inspector Petra Rempe, PhD, Josef Künzle, PhD, Head of Global Quality Management at Basilea

Protocol: Sabine Paris, PhD

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