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22.07.2024 | QUESTION OF THE WEEK

Which different types of stainless steel are available?


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19.07.2024 | NEWS

EU: New Regulation on Substances of Human Origin (SoHO)

The European Commission has published a new Regulation (2024/1938) providing new rules on standards of quality and safety for substances of human origin (SoHO).


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15.07.2024 | QUESTION OF THE WEEK

What general hygiene measures need to be observed in storage areas?


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12.07.2024 | NEWS

EMA: Updated Appendix 1 of the Nitrosamine Q&As

The European Medicines Agency (EMA) updated Appendix 1 (EMA/307633/2024 /Rev. 5) of the Nitrosamine Q&As, listing nitrosamines with established Acceptable Intake (AI) values.


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09.07.2024 | LOGFILE Feature 14/2024

Agency Expectations on PDE Determination and PDE Reports

7 min. reading time | by Sabine Paris, PhD

In 2015, with the revision of Chapters 3 and 5 and Annex 15 of the EU GMP Guide and with the publication of the EMA PDE Guideline a paradigm shift occurred in the setting of limits for the validation of cleaning processes. Instead of the previously used criteria, such as 10 ppm or 1/1000 of the therapeutic dose of the foregoing product, the only acceptable criterion is now a toxicological risk assessment based on PDE values.


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25.06.2024 | LOGFILE Feature 13/2024

Clean up Period and Recovery Time

5 min. reading time | by Harald Flechl

Both of the terms "clean up period" (Annex 1) and "recovery time" (ISO 14644-3, informative part B.4) are often used to describe the same procedure but they are completely different from each other. These test methods have no validity with respect to the airborne microbes, which depend greatly upon the number of persons in the room as well as their clothing and activity.


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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!


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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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22.07.2024 | QUESTION OF THE WEEK

Which different types of stainless steel are available?


read more ...
15.07.2024 | QUESTION OF THE WEEK

What general hygiene measures need to be observed in storage areas?


read more ...
09.07.2024 | LOGFILE Feature 14/2024

Agency Expectations on PDE Determination and PDE Reports

7 min. reading time | by Sabine Paris, PhD

In 2015, with the revision of Chapters 3 and 5 and Annex 15 of the EU GMP Guide and with the publication of the EMA PDE Guideline a paradigm shift occurred in the setting of limits for the validation of cleaning processes. Instead of the previously used criteria, such as 10 ppm or 1/1000 of the therapeutic dose of the foregoing product, the only acceptable criterion is now a toxicological risk assessment based on PDE values.


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 ...
19.07.2024 | NEWS

EU: New Regulation on Substances of Human Origin (SoHO)

The European Commission has published a new Regulation (2024/1938) providing new rules on standards of quality and safety for substances of human origin (SoHO).


read more ...
12.07.2024 | NEWS

EMA: Updated Appendix 1 of the Nitrosamine Q&As

The European Medicines Agency (EMA) updated Appendix 1 (EMA/307633/2024 /Rev. 5) of the Nitrosamine Q&As, listing nitrosamines with established Acceptable Intake (AI) values.


read more ...
25.06.2024 | LOGFILE Feature 13/2024

Clean up Period and Recovery Time

5 min. reading time | by Harald Flechl

Both of the terms "clean up period" (Annex 1) and "recovery time" (ISO 14644-3, informative part B.4) are often used to describe the same procedure but they are completely different from each other. These test methods have no validity with respect to the airborne microbes, which depend greatly upon the number of persons in the room as well as their clothing and activity.


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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