10.02.2025
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QUESTION OF THE WEEK
GMP:Blog
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07.02.2025
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NEWS
BfArM: AMIce Public Part Becomes Completely Free of Charge
From 13 February, the Federal Institute for Drugs and Medical Devices (BfArM) will offer the public part of the drug information system (AMIce) in its entirety for free research.
read more ...
04.02.2025
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LOGFILE Feature 03/2025
Regulatory Requirements for the Validation of Analytical Methods – Part 1
7 min. reading time | by Joachim Ermer
Proof of the suitability of analytical test methods is a general GMP requirement. While the EU GMP Guideline Part I generally requires "validated test methods", Part II refers to the ICH guidelines with regard to the content of method validation. 21 CFR Part 211 also requires in §194(a)(2) that the suitability of the test methods must be verified.
read more ...
03.02.2025
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QUESTION OF THE WEEK
20.01.2025
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AUTHOR
Our Authors
Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!
read more ...
07.01.2025
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LOGFILE Feature 01/2025
Supply Shortages – is a Solution in Sight?
5 min. reading time | by Doris Borchert, PhD
Supply shortages for pharmaceuticals are a serious problem for the public security of drug product supply. At the 30th GMP Conference, Dr. Josef Landwehr (PTS), Thomas Brückner (Bundesverband der Pharmazeutischen Industrie e.V.) and Andrea Schmitz (Pharma Deutschland e.V.) discussed the background, possible solutions and foreseeable developments in this area.
We have summarised the most important questions and answers for you.
read more ...
02.01.2025
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AUTHOR
Dr. Birte Scharf
Birte Scharf, PhD, is a pharmacist and works as a Senior Scientist in the GMP Compliance Team at Franz Ziel GmbH.
read more ...
10.06.2021
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ASK OUR EXPERTS
Are there any requirements regarding the microbiological monitoring of sewage drains in production rooms?
Should there be a microbiological monitoring program in place specifically for the drains?
First of all, drains in production rooms are not permitted in class A/B (EU GMP Guide, Annex 1 No. 50) which means the question should refer exclusively to production rooms starting with class C. Further information on the construction of drains can be found in EU GMP Guide Part I, 3.11.
read more ...
01.09.2020
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ASK OUR EXPERTS
Late, but not too late: How to best define the final time point of a stability study
"What is the best procedure for selecting samples from a stability chamber in the final test interval of ongoing stability tests?"
read more ...
10.02.2025
|
QUESTION OF THE WEEK
03.02.2025
|
QUESTION OF THE WEEK
07.01.2025
|
LOGFILE Feature 01/2025
Supply Shortages – is a Solution in Sight?
5 min. reading time | by Doris Borchert, PhD
Supply shortages for pharmaceuticals are a serious problem for the public security of drug product supply. At the 30th GMP Conference, Dr. Josef Landwehr (PTS), Thomas Brückner (Bundesverband der Pharmazeutischen Industrie e.V.) and Andrea Schmitz (Pharma Deutschland e.V.) discussed the background, possible solutions and foreseeable developments in this area.
We have summarised the most important questions and answers for you.
read more ...
10.06.2021
|
ASK OUR EXPERTS
Are there any requirements regarding the microbiological monitoring of sewage drains in production rooms?
Should there be a microbiological monitoring program in place specifically for the drains?
First of all, drains in production rooms are not permitted in class A/B (EU GMP Guide, Annex 1 No. 50) which means the question should refer exclusively to production rooms starting with class C. Further information on the construction of drains can be found in EU GMP Guide Part I, 3.11.
read more ...
07.02.2025
|
NEWS
BfArM: AMIce Public Part Becomes Completely Free of Charge
From 13 February, the Federal Institute for Drugs and Medical Devices (BfArM) will offer the public part of the drug information system (AMIce) in its entirety for free research.
read more ...
04.02.2025
|
LOGFILE Feature 03/2025
Regulatory Requirements for the Validation of Analytical Methods – Part 1
7 min. reading time | by Joachim Ermer
Proof of the suitability of analytical test methods is a general GMP requirement. While the EU GMP Guideline Part I generally requires "validated test methods", Part II refers to the ICH guidelines with regard to the content of method validation. 21 CFR Part 211 also requires in §194(a)(2) that the suitability of the test methods must be verified.
read more ...
20.01.2025
|
AUTHOR
Our Authors
Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!
read more ...
02.01.2025
|
AUTHOR
Dr. Birte Scharf
Birte Scharf, PhD, is a pharmacist and works as a Senior Scientist in the GMP Compliance Team at Franz Ziel GmbH.
read more ...
01.09.2020
|
ASK OUR EXPERTS
Late, but not too late: How to best define the final time point of a stability study
"What is the best procedure for selecting samples from a stability chamber in the final test interval of ongoing stability tests?"
read more ...