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01.07.2022 | NEWS

ICMRA: Regulatory Collaboration Pilots

ICMRA: Regulatory Collaboration Pilots

The International Coalition of Medicines Regulatory Authorities (ICMRA) is announcing the initiation of two regulatory collaboration pilots addressing facility inspections and Chemistry and Manufacturing Controls (CMC) and Post-Approval Change (PAC) submission assessments and related regulatory actions.


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01.07.2022 | NEWS

FDA: Draft on Contamination Prevention for Non-Penicillin Beta-Lactam Drugs

FDA: Draft on Contamination Prevention for Non-Penicillin Beta-Lactam Drugs

The FDA issued a draft guidance outlining a framework of methods, designs and controls for preventing cross-contamination of non-penicillin beta-lactam antibacterial drugs and compounds, which serves as an update for a 2013 guidance with the same title. (Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination; Draft Guidance for Industry; Availability).


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27.06.2022 | QUESTION OF THE WEEK

Where do SOPs need to be available?


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20.06.2022 | QUESTION OF THE WEEK

What is a verified copy?


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15.06.2022 | AUTHOR

Brian Glass

Brian Glass

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14.06.2022 | LOGFILE Feature 23/2022

How is process validation differentiated from other elements of quality management?

How is process validation differentiated from other elements of quality management?

8 min. reading time | by Thomas Peither

 

The question "How does process validation differentiate itself from other elements of quality management?" is not easy to answer, because there is still no uniform and generally applicable definition for validation. On the contrary, the term is becoming increasingly blurred with the related technical terms qualification and verification.


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31.05.2022 | LOGFILE Feature 21/2022

Import of Medicinal Products – Clarifications in Annex 21

Import of Medicinal Products – Clarifications in Annex 21

10 min. reading time | by Sabine Paris, PhD

 

The new Annex 21: Importation of medicinal products to the EU GMP Guide has been published on February 21, 2022 and will enter into force on August 21, 2022. The 6-page annex summarises the GMP requirements for Manufacturer/Importer Authorisation (MIA) holders to import medicinal products (human, investigational and veterinary) from outside the EU/EEA (we reported).


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10.06.2021 | ASK OUR EXPERTS

Are there any requirements regarding the microbiological monitoring of sewage drains in production rooms?

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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01.06.2021 | AUTHOR

Petra Berlemann

Petra Berlemann

Petra Berlemann has been working in various areas of quality management since 2007.


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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?

Late, but not too late? How to best define the final time point of a stability study?

read more ...
01.07.2022 | NEWS

ICMRA: Regulatory Collaboration Pilots

ICMRA: Regulatory Collaboration Pilots

The International Coalition of Medicines Regulatory Authorities (ICMRA) is announcing the initiation of two regulatory collaboration pilots addressing facility inspections and Chemistry and Manufacturing Controls (CMC) and Post-Approval Change (PAC) submission assessments and related regulatory actions.


read more ...
27.06.2022 | QUESTION OF THE WEEK

Where do SOPs need to be available?


read more ...
15.06.2022 | AUTHOR

Brian Glass

Brian Glass

read more ...
31.05.2022 | LOGFILE Feature 21/2022

Import of Medicinal Products – Clarifications in Annex 21

Import of Medicinal Products – Clarifications in Annex 21

10 min. reading time | by Sabine Paris, PhD

 

The new Annex 21: Importation of medicinal products to the EU GMP Guide has been published on February 21, 2022 and will enter into force on August 21, 2022. The 6-page annex summarises the GMP requirements for Manufacturer/Importer Authorisation (MIA) holders to import medicinal products (human, investigational and veterinary) from outside the EU/EEA (we reported).


read more ...
01.06.2021 | AUTHOR

Petra Berlemann

Petra Berlemann

Petra Berlemann has been working in various areas of quality management since 2007.


read more ...
01.07.2022 | NEWS

FDA: Draft on Contamination Prevention for Non-Penicillin Beta-Lactam Drugs

FDA: Draft on Contamination Prevention for Non-Penicillin Beta-Lactam Drugs

The FDA issued a draft guidance outlining a framework of methods, designs and controls for preventing cross-contamination of non-penicillin beta-lactam antibacterial drugs and compounds, which serves as an update for a 2013 guidance with the same title. (Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination; Draft Guidance for Industry; Availability).


read more ...
20.06.2022 | QUESTION OF THE WEEK

What is a verified copy?


read more ...
14.06.2022 | LOGFILE Feature 23/2022

How is process validation differentiated from other elements of quality management?

How is process validation differentiated from other elements of quality management?

8 min. reading time | by Thomas Peither

 

The question "How does process validation differentiate itself from other elements of quality management?" is not easy to answer, because there is still no uniform and generally applicable definition for validation. On the contrary, the term is becoming increasingly blurred with the related technical terms qualification and verification.


read more ...
10.06.2021 | ASK OUR EXPERTS

Are there any requirements regarding the microbiological monitoring of sewage drains in production rooms?

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 | ASK OUR EXPERTS

Late, but not too late? How to best define the final time point of a stability study?

Late, but not too late? How to best define the final time point of a stability study?

read more ...

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