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30.09.2022 | NEWS

USP: Draft for a Cannabis Monograph

USP: Draft for a Cannabis Monograph

The United States Pharmacopeia (USP) has opened a 90-day review period for their proposed Cannabis Species Inflorescence Monograph in the Herbal Medicines Compendium (HMC), a laboratory quality standards testing reference used internationally. 


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26.09.2022 | QUESTION OF THE WEEK

What are endotoxins?


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23.09.2022 | NEWS

EMA: Draft Quality Guidelines for Synthetic Peptides and Oligonucleotides

EMA: Draft Quality Guidelines for Synthetic Peptides and Oligonucleotides

The European Medicines Agency (EMA) plans to establish clear quality guidelines for drug companies manufacturing synthetic peptides and oligonucleotides. This week, EMA published new concept papers, explaining current requirements on impurities testing, specifications and the control of DNA-reactive chemicals either partly or fully exclude synthetic peptides and oligonucleotides.


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19.09.2022 | QUESTION OF THE WEEK

Can operators of existing systems for the production of highly purified water (HPW) still refer to the Ph. Eur. now that HPW is no longer listed there?


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30.08.2022 | LOGFILE Feature 32/2022

The new Annex 1 for the Manufacture of Sterile Medicinal Products – Focus: Barrier Systems

The new Annex 1 for the Manufacture of Sterile Medicinal Products – Focus: Barrier Systems

8 min. reading time | by Richard Denk

The first draft of version 9 of Annex 1 of the EU GMP Guide on 20 December 2017 attracted a lot of interest globally – firstly because it was the first publication on the topic in almost a decade, and secondly because PIC/S and WHO co-authored the document.


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26.07.2022 | LOGFILE Feature 29/2022

Reaching the next GMP Level with Inspection Readiness Projects

Reaching the next GMP Level with Inspection Readiness Projects

9 min. reading time | by Frank Studt and Thomas Peither


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15.06.2022 | AUTHOR

Brian Glass

Brian Glass
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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30.09.2022 | NEWS

USP: Draft for a Cannabis Monograph

USP: Draft for a Cannabis Monograph

The United States Pharmacopeia (USP) has opened a 90-day review period for their proposed Cannabis Species Inflorescence Monograph in the Herbal Medicines Compendium (HMC), a laboratory quality standards testing reference used internationally. 


read more ...
23.09.2022 | NEWS

EMA: Draft Quality Guidelines for Synthetic Peptides and Oligonucleotides

EMA: Draft Quality Guidelines for Synthetic Peptides and Oligonucleotides

The European Medicines Agency (EMA) plans to establish clear quality guidelines for drug companies manufacturing synthetic peptides and oligonucleotides. This week, EMA published new concept papers, explaining current requirements on impurities testing, specifications and the control of DNA-reactive chemicals either partly or fully exclude synthetic peptides and oligonucleotides.


read more ...
30.08.2022 | LOGFILE Feature 32/2022

The new Annex 1 for the Manufacture of Sterile Medicinal Products – Focus: Barrier Systems

The new Annex 1 for the Manufacture of Sterile Medicinal Products – Focus: Barrier Systems

8 min. reading time | by Richard Denk

The first draft of version 9 of Annex 1 of the EU GMP Guide on 20 December 2017 attracted a lot of interest globally – firstly because it was the first publication on the topic in almost a decade, and secondly because PIC/S and WHO co-authored the document.


read more ...
15.06.2022 | AUTHOR

Brian Glass

Brian Glass
01.06.2021 | AUTHOR

Petra Berlemann

Petra Berlemann

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


read more ...
26.09.2022 | QUESTION OF THE WEEK

What are endotoxins?


read more ...
19.09.2022 | QUESTION OF THE WEEK

Can operators of existing systems for the production of highly purified water (HPW) still refer to the Ph. Eur. now that HPW is no longer listed there?


read more ...
26.07.2022 | LOGFILE Feature 29/2022

Reaching the next GMP Level with Inspection Readiness Projects

Reaching the next GMP Level with Inspection Readiness Projects

9 min. reading time | by Frank Studt and Thomas Peither


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 ...

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