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18.03.2024 | QUESTION OF THE WEEK

For what purposes are isolators used?


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15.03.2024 | NEWS

EC: Harmonised Standards for Medical Device Sterilisation

The European Commission adopted two implementing decisions on the sterilisation of medical devices. These decisions were made in accordance with the regulations governing medical devices and in vitro diagnostics (IVDs) in the EU.


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11.03.2024 | QUESTION OF THE WEEK

How can the specific requirements for sterile products be taken into account in the quality management system?


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08.03.2024 | NEWS

ECJ: European Standards Should be Freely Accessible

The European Court of Justice (ECJ) has ruled that harmonised technical standards are part of EU law and should therefore be freely accessible to EU citizens (Judgment of 05.03.2024, ref. C-588/21 P).


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05.03.2024 | LOGFILE Feature 5/2024

Tests in the New Ph. Eur. Monograph on Cannabis Flower

5 min. reading time | by Sabine Paris

The monograph on Cannabis flower (3028) has been published in Ph. Eur. Supplement 11.5 in January 2024, with an implementation date of 1 July 2024. All member states of the European Pharmacopoeia are required to replace their national monographs with this new Ph. Eur. Monograph.


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29.01.2024 | AUTHOR

Our Authors

Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!


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23.01.2024 | LOGFILE Feature 2/2024

Can GMP Data be in the Cloud?

7 min. reading time | by Thomas Peither

What is cloud computing?

Cloud computing is not a new technology, but a new way of providing resources for data processing.


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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.


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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?"


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18.03.2024 | QUESTION OF THE WEEK

For what purposes are isolators used?


read more ...
11.03.2024 | QUESTION OF THE WEEK

How can the specific requirements for sterile products be taken into account in the quality management system?


read more ...
05.03.2024 | LOGFILE Feature 5/2024

Tests in the New Ph. Eur. Monograph on Cannabis Flower

5 min. reading time | by Sabine Paris

The monograph on Cannabis flower (3028) has been published in Ph. Eur. Supplement 11.5 in January 2024, with an implementation date of 1 July 2024. All member states of the European Pharmacopoeia are required to replace their national monographs with this new Ph. Eur. Monograph.


read more ...
23.01.2024 | LOGFILE Feature 2/2024

Can GMP Data be in the Cloud?

7 min. reading time | by Thomas Peither

What is cloud computing?

Cloud computing is not a new technology, but a new way of providing resources for data processing.


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 ...
15.03.2024 | NEWS

EC: Harmonised Standards for Medical Device Sterilisation

The European Commission adopted two implementing decisions on the sterilisation of medical devices. These decisions were made in accordance with the regulations governing medical devices and in vitro diagnostics (IVDs) in the EU.


read more ...
08.03.2024 | NEWS

ECJ: European Standards Should be Freely Accessible

The European Court of Justice (ECJ) has ruled that harmonised technical standards are part of EU law and should therefore be freely accessible to EU citizens (Judgment of 05.03.2024, ref. C-588/21 P).


read more ...
29.01.2024 | AUTHOR

Our Authors

Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!


read more ...
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 ...

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