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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.


read more ...
23.09.2022 | NEWS

PIC/S: Publication of Revised GMP Annex 1

PIC/S: Publication of Revised GMP Annex 1

The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).


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20.09.2022 | LOGFILE Leitartikel 35/2022

Kalibrierung der Messstellen bei Pharmawasser-systemen

Kalibrierung der Messstellen bei Pharmawasser-systemen

7 Min. Lesezeit | von Fritz Röder

 

Die Kalibrierung der Messstellen ist von enormer Bedeutung, denn nur mit richtigen Werten kann der Zustand der Anlage korrekt interpretiert werden. Die Kalibrierung ist auch eine grundsätzliche Vorgabe aus dem EU-GMP-Leitfaden (Punkt 3.41 EU-GMP-Leitfaden). Deshalb ist es unbedingt notwendig, die Kalibrierung von qualitätsrelevanten Messeinrichtungen genauso regelmäßig durchzuführen wie Wartungen.


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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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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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26.09.2022 | QUESTION OF THE WEEK

What are endotoxins?


read more ...
23.09.2022 | NEWS

PIC/S: Publication of Revised GMP Annex 1

PIC/S: Publication of Revised GMP Annex 1

The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences).


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 ...
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 ...
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 ...
20.09.2022 | LOGFILE Leitartikel 35/2022

Kalibrierung der Messstellen bei Pharmawasser-systemen

Kalibrierung der Messstellen bei Pharmawasser-systemen

7 Min. Lesezeit | von Fritz Röder

 

Die Kalibrierung der Messstellen ist von enormer Bedeutung, denn nur mit richtigen Werten kann der Zustand der Anlage korrekt interpretiert werden. Die Kalibrierung ist auch eine grundsätzliche Vorgabe aus dem EU-GMP-Leitfaden (Punkt 3.41 EU-GMP-Leitfaden). Deshalb ist es unbedingt notwendig, die Kalibrierung von qualitätsrelevanten Messeinrichtungen genauso regelmäßig durchzuführen wie Wartungen.


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 ...
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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