07.10.2024
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QUESTION OF THE WEEK
GMP:Blog
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04.10.2024
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NEWS
EMA: Draft Guideline on Elemental Impurities in Veterinary Medicines
The EMA has published for consultation the draft guideline on risk management requirements for elemental impurities in veterinary medicinal products (VMPs). As the Ph. Eur. General Monograph 2619 on pharmaceutical preparations applies to all VMPs, risk management of elemental impurities in all VMPs in the EU market is expected.
read more ...
01.10.2024
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LOGFILE Feature 20/2024
Insights from the PDA/FDA Joint Regulatory Conference 2024
7 min. reading time | by Sabine Paris, PhD, and Thomas Peither
The 33rd Annual PDA/FDA Joint Regulatory Conference was held in Washington from September 9-11, bringing together over 900 participants. It was a great opportunity for knowledge sharing, connecting theory with real-world practice, and plenty of networking.
We attended the event as representatives of GMP-Verlag and have highlighted some of the key takeaways in this article. The full report will soon be available on our online GMP knowledge portal, the GMP Compliance Adviser.
read more ...
30.09.2024
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QUESTION OF THE WEEK
27.09.2024
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NEWS
Swissmedic: SwissGMDP Database Launched
Swissmedic has launched the SwissGMDP database, which gives public access to GMP and GDP certificates of all authorised Swiss pharmaceutical companies.
read more ...
17.09.2024
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LOGFILE Feature 19/2024
Concepts for the Separation of Clean Rooms
3 min. reading time | by Raimund Brett
Between rooms of different cleanliness grades, it is required to establish a pressure cascade to prevent cross contamination. Annex 1 of the EU GMP Guide requires a pressure difference of at least 10 Pascal between two different cleanliness classes. These pressures can be achieved if the structure (walls, ceiling, windows and doors) is tight. The pressure level is usually controlled in such a way that the supply air is kept constant, and the exhaust air is controlled via volume flow controllers to maintain the corresponding pressure difference. The pressure differences in a manufacturing area for sterile pharmaceuticals must be continuously measured and recorded. If a pressure drop occurs, an alarm must be triggered. This also applies to the airlocks.
read more ...
14.04.2024
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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 ...
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 ...
07.10.2024
|
QUESTION OF THE WEEK
01.10.2024
|
LOGFILE Feature 20/2024
Insights from the PDA/FDA Joint Regulatory Conference 2024
7 min. reading time | by Sabine Paris, PhD, and Thomas Peither
The 33rd Annual PDA/FDA Joint Regulatory Conference was held in Washington from September 9-11, bringing together over 900 participants. It was a great opportunity for knowledge sharing, connecting theory with real-world practice, and plenty of networking.
We attended the event as representatives of GMP-Verlag and have highlighted some of the key takeaways in this article. The full report will soon be available on our online GMP knowledge portal, the GMP Compliance Adviser.
read more ...
27.09.2024
|
NEWS
Swissmedic: SwissGMDP Database Launched
Swissmedic has launched the SwissGMDP database, which gives public access to GMP and GDP certificates of all authorised Swiss pharmaceutical companies.
read more ...
14.04.2024
|
AUTHOR
Our Authors
Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!
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 ...
04.10.2024
|
NEWS
EMA: Draft Guideline on Elemental Impurities in Veterinary Medicines
The EMA has published for consultation the draft guideline on risk management requirements for elemental impurities in veterinary medicinal products (VMPs). As the Ph. Eur. General Monograph 2619 on pharmaceutical preparations applies to all VMPs, risk management of elemental impurities in all VMPs in the EU market is expected.
read more ...
30.09.2024
|
QUESTION OF THE WEEK
17.09.2024
|
LOGFILE Feature 19/2024
Concepts for the Separation of Clean Rooms
3 min. reading time | by Raimund Brett
Between rooms of different cleanliness grades, it is required to establish a pressure cascade to prevent cross contamination. Annex 1 of the EU GMP Guide requires a pressure difference of at least 10 Pascal between two different cleanliness classes. These pressures can be achieved if the structure (walls, ceiling, windows and doors) is tight. The pressure level is usually controlled in such a way that the supply air is kept constant, and the exhaust air is controlled via volume flow controllers to maintain the corresponding pressure difference. The pressure differences in a manufacturing area for sterile pharmaceuticals must be continuously measured and recorded. If a pressure drop occurs, an alarm must be triggered. This also applies to the airlocks.
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 ...