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16.04.2024 | LOGFILE Feature 8/2024

Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 1

7 min. reading time | by Birte Scharf, PhD

What are advanced therapy medicinal products (ATMPs)?

Advanced therapy medicinal products (ATMPs) are an innovative class of medicinal products characterised by the use of advanced technologies.They target the underlying genetic, cellular, or tissue-based abnormalities of diseases and thus offer the potential for cure or at least a long-term therapeutic benefit.


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15.04.2024 | QUESTION OF THE WEEK

What was the reason for the revision of Annex 1?


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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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12.04.2024 | NEWS

EU: Parliament Adopts Position on EU Pharmaceutical Reform

On 10 April, the EU Parliament approved a legislative package to reform the EU‘s pharmaceutical legislation, with the aim of boosting innovation and improving the accessibility and affordability of medicines. The package, which includes a new directive and a regulation, recieved strong support from Members of the European Parliament (MEPs).


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12.04.2024 | NEWS

EDQM: European and Japanese Pharmacopeias Launch Harmonisation Project

The Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (Ph. Eur.) are launching a joint project to harmonise pharmacopoeial standards for active substances and medicinal products. This initiative aims to reduce the burden on manufacturers by aligning pharmacopoeial standards across different regulatory regions.


read more ...
09.04.2024 | LOGFILE Feature 7/2024

30 Years of GMP - A Personal View on Good Manufacturing Practices

10 min. reading time | by Thomas Peither

When I worked on the first GMP projects as a consultant in 1994, the internet was still in its infancy. Getting an official copy of 21 CFR 210/211 was more than a hassle. You had to send a written request to the USA and after weeks, a barely legible copy would arrive by post.


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08.04.2024 | QUESTION OF THE WEEK

What are the major trends that have recently changed the concept of validation?


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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 ...
16.04.2024 | LOGFILE Feature 8/2024

Highly Innovative Medicines: Advanced Therapy Medicinal Products (ATMPs) – Part 1

7 min. reading time | by Birte Scharf, PhD

What are advanced therapy medicinal products (ATMPs)?

Advanced therapy medicinal products (ATMPs) are an innovative class of medicinal products characterised by the use of advanced technologies.They target the underlying genetic, cellular, or tissue-based abnormalities of diseases and thus offer the potential for cure or at least a long-term therapeutic benefit.


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 ...
12.04.2024 | NEWS

EDQM: European and Japanese Pharmacopeias Launch Harmonisation Project

The Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (Ph. Eur.) are launching a joint project to harmonise pharmacopoeial standards for active substances and medicinal products. This initiative aims to reduce the burden on manufacturers by aligning pharmacopoeial standards across different regulatory regions.


read more ...
08.04.2024 | QUESTION OF THE WEEK

What are the major trends that have recently changed the concept of validation?


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 ...
15.04.2024 | QUESTION OF THE WEEK

What was the reason for the revision of Annex 1?


read more ...
12.04.2024 | NEWS

EU: Parliament Adopts Position on EU Pharmaceutical Reform

On 10 April, the EU Parliament approved a legislative package to reform the EU‘s pharmaceutical legislation, with the aim of boosting innovation and improving the accessibility and affordability of medicines. The package, which includes a new directive and a regulation, recieved strong support from Members of the European Parliament (MEPs).


read more ...
09.04.2024 | LOGFILE Feature 7/2024

30 Years of GMP - A Personal View on Good Manufacturing Practices

10 min. reading time | by Thomas Peither

When I worked on the first GMP projects as a consultant in 1994, the internet was still in its infancy. Getting an official copy of 21 CFR 210/211 was more than a hassle. You had to send a written request to the USA and after weeks, a barely legible copy would arrive by post.


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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