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28.11.2023 | LOGFILE Feature 45/2023

GMP Question of the Week: Top 15 in 2023

5 min. reading time | by GMP-Verlag Peither AG

Every week we publish interesting questions and answers about GMP in our column GMP Question of the Week. Today we have compiled the most clicked questions of this year (as of November 2023).

Browse the Top 15 and refresh your knowledge!

Detailed information on each topic can be found in the GMP Compliance Adviser, the world's largest reference work on quality management in the pharmaceutical industry.


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27.11.2023 | QUESTION OF THE WEEK

How should the qualification be documented?


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24.11.2023 | NEWS

Swissmedic: Technical Interpretation on Annex 1 Published

On 31 October 2023, Swissmedic published a Q&A with the title "Interpretation of GMP Annex 1 2022 (Rev. 1)". In the 25-page document, the Swiss Agency for Therapeutic Products provides key answers to questions related to Annex 1, which came into force in August 2023, and to repeatedly asked questions from the previous version.


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20.11.2023 | QUESTION OF THE WEEK

How should one handle qualification data?


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17.11.2023 | NEWS

ICH: Q5A(R2) Guideline on Viral Safety of Biotechnology Products adopted

The Assembly of the International Council for Harmonisation (ICH) has adopted the revised Q5A(R2) Guideline on the Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. The guideline describes a general approach to testing and assessing the viral safety of those products and sets out the data that should be submitted in marketing authorisation applications and registration packages. These products include biotherapeutics and biological products derived from characterised cell cultures of human or animal origin (mammals, birds, insects). The term "virus" used therein does not include non-conventionally transmissible pathogens, such as mammalian prion-associated pathogens.


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14.11.2023 | LOGFILE Feature 43/2023

Nothing lasts Forever: Stability Tests are Indispensable

7 min. reading time | by Thomas Peither

The stability of a medicinal product or an active substance is defined as the maintenance of certain quality characteristics (specification) over a fixed period of time under defined conditions.


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02.11.2023 | 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?"


read more ...
28.11.2023 | LOGFILE Feature 45/2023

GMP Question of the Week: Top 15 in 2023

5 min. reading time | by GMP-Verlag Peither AG

Every week we publish interesting questions and answers about GMP in our column GMP Question of the Week. Today we have compiled the most clicked questions of this year (as of November 2023).

Browse the Top 15 and refresh your knowledge!

Detailed information on each topic can be found in the GMP Compliance Adviser, the world's largest reference work on quality management in the pharmaceutical industry.


read more ...
24.11.2023 | NEWS

Swissmedic: Technical Interpretation on Annex 1 Published

On 31 October 2023, Swissmedic published a Q&A with the title "Interpretation of GMP Annex 1 2022 (Rev. 1)". In the 25-page document, the Swiss Agency for Therapeutic Products provides key answers to questions related to Annex 1, which came into force in August 2023, and to repeatedly asked questions from the previous version.


read more ...
17.11.2023 | NEWS

ICH: Q5A(R2) Guideline on Viral Safety of Biotechnology Products adopted

The Assembly of the International Council for Harmonisation (ICH) has adopted the revised Q5A(R2) Guideline on the Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. The guideline describes a general approach to testing and assessing the viral safety of those products and sets out the data that should be submitted in marketing authorisation applications and registration packages. These products include biotherapeutics and biological products derived from characterised cell cultures of human or animal origin (mammals, birds, insects). The term "virus" used therein does not include non-conventionally transmissible pathogens, such as mammalian prion-associated pathogens.


read more ...
02.11.2023 | 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 ...
27.11.2023 | QUESTION OF THE WEEK

How should the qualification be documented?


read more ...
20.11.2023 | QUESTION OF THE WEEK

How should one handle qualification data?


read more ...
14.11.2023 | LOGFILE Feature 43/2023

Nothing lasts Forever: Stability Tests are Indispensable

7 min. reading time | by Thomas Peither

The stability of a medicinal product or an active substance is defined as the maintenance of certain quality characteristics (specification) over a fixed period of time under defined conditions.


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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