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16.05.2022 | QUESTION OF THE WEEK

Which parameters determine the result of cleaning according to Sinner's circle?


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13.05.2022 | NEWS

MDCG: Guidance on transitional provision of IVDR

MDCG: Guidance on transitional provision of IVDR

On 26 May 2022, the European IVD Regulation (EU) 2017/746 (In vitro Device Regulation) will enter into force. This will be accompanied by various transitional periods and requirements, which have been summarised and explained by the MDCG (Medical Device Coordination Group) in a new guidance document. The 17-page Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR is aimed at manufacturers who have so far complied with the requirements of Directive 98/79/EC and may continue to market their in vitro diagnostic devices in accordance with this Directive during the transitional periods.


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13.05.2022 | NEWS

EMA: Updating of Good Clinical Practice Annexes

EMA: Updating of Good Clinical Practice Annexes

The European Medicines Agency (EMA) has updated the annexes for the conduct of GCP inspections. First published in 2007, the annexes compile a number of seven documents.


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09.05.2022 | QUESTION OF THE WEEK

What has to be considered in risk management?


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03.05.2022 | LOGFILE Feature 17/2022

CAPA Systems: Autonomous or Integrated?

CAPA Systems: Autonomous or Integrated?

8 min. reading time | by Thomas Peither

 

A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. In principle, it can be implemented in two different ways: as an autonomous or as an integrated system.


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19.04.2022 | LOGFILE Feature 15/2022

Risk analysis in the equipment life cycle

Risk analysis in the equipment life cycle

5 min. reading time |

 

From the start of the project to the release of the technical design: Risk analysis is a constant companion.
Risk analyses can or must be carried out at different points in time within the process of procurement and qualification. Here is a brief outline of the phases of risk analyses in project implementation.


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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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01.01.2021 | AUTHOR

Michael Craig

Michael Craig

As a Principal Consultant at PAREXEL Michael Craig helps clients prepare their CTA, marketing authorisation and variation submissions as a CMC Subject Matter Expert and provides regulatory and technical input for lifecycle activities in European and international markets.


read more ...
16.05.2022 | QUESTION OF THE WEEK

Which parameters determine the result of cleaning according to Sinner's circle?


read more ...
13.05.2022 | NEWS

EMA: Updating of Good Clinical Practice Annexes

EMA: Updating of Good Clinical Practice Annexes

The European Medicines Agency (EMA) has updated the annexes for the conduct of GCP inspections. First published in 2007, the annexes compile a number of seven documents.


read more ...
03.05.2022 | LOGFILE Feature 17/2022

CAPA Systems: Autonomous or Integrated?

CAPA Systems: Autonomous or Integrated?

8 min. reading time | by Thomas Peither

 

A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. In principle, it can be implemented in two different ways: as an autonomous or as an integrated system.


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 ...
01.01.2021 | AUTHOR

Michael Craig

Michael Craig

As a Principal Consultant at PAREXEL Michael Craig helps clients prepare their CTA, marketing authorisation and variation submissions as a CMC Subject Matter Expert and provides regulatory and technical input for lifecycle activities in European and international markets.


read more ...
13.05.2022 | NEWS

MDCG: Guidance on transitional provision of IVDR

MDCG: Guidance on transitional provision of IVDR

On 26 May 2022, the European IVD Regulation (EU) 2017/746 (In vitro Device Regulation) will enter into force. This will be accompanied by various transitional periods and requirements, which have been summarised and explained by the MDCG (Medical Device Coordination Group) in a new guidance document. The 17-page Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR is aimed at manufacturers who have so far complied with the requirements of Directive 98/79/EC and may continue to market their in vitro diagnostic devices in accordance with this Directive during the transitional periods.


read more ...
09.05.2022 | QUESTION OF THE WEEK

What has to be considered in risk management?


read more ...
19.04.2022 | LOGFILE Feature 15/2022

Risk analysis in the equipment life cycle

Risk analysis in the equipment life cycle

5 min. reading time |

 

From the start of the project to the release of the technical design: Risk analysis is a constant companion.
Risk analyses can or must be carried out at different points in time within the process of procurement and qualification. Here is a brief outline of the phases of risk analyses in project implementation.


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 ...

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