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GMP LOGFILE: Lead Article
LOGFILE Feature 20/2020 – Challenges lurking in manufacturing
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 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
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
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?
Batch Designation: Handwritten or Electronic?
Ask our Experts
5 minutes reading time
by Doris Borchert
LOGFILE Feature 15/2020 – Acceptance testing or qualification?
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"
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
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?
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
Questions about manufacturing technology
7 minutes reading time
by Doris Borchert, PhD
LOGFILE Feature 10/2020 – Trust is good, calibration is better!
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
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
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
LOGFILE Feature 07/2020 – MHRA: Feedback from GMP inspections
MHRA: Feedback from GMP inspections
15 minutes reading time
by Tim Sandle
LOGFILE Feature 06/2020 – Packaging material testing
Packaging material testing
An excerpt from the new e-book GMP Series Packaging Materials for Pharmaceutical Products
5 minutes reading time
by André Deister, Sabine Mendel
LOGFILE Feature 05/2020 – TOP 15 Countdown: “Question of the Week”
TOP 15 Countdown: “Question of the Week”
LOGFILE Feature 04/2020 – Microbiological monitoring in non-sterile areas
Microbiological monitoring in non-sterile areas
A summary of the GMP DIALOGUE at the GMP-BERATER Tage 2019
7 minutes reading time
by Doris Borchert, PhD
LOGFILE Feature 03/2020 – Selection and procurement of cleanroom construction components
Selection and procurement of cleanroom construction components
An excerpt from the new e-book A Pharma Guide to Planning and Constructing Cleanrooms
5 minutes reading time
by André Deister, Sabine Mendel
LOGFILE Feature 02/2020 – GDP inspections: How to avoid defects
GDP inspections: How to avoid defects
Interview with Lea Joos, GMP inspector and author of the new GMP Compliance Adviser Chapter 16.S.2 "GDP inspections: frequent deficiencies in the qualification of logistics service providers and how to avoid them"
7 minutes reading time
by Lea Joos and Doris Borchert
LOGFILE Feature 01/2020 – Your question – our answer: Environmental Monitoring
Your question – our answer
Question about environmental monitoring
7 minutes reading time