GMP:Blog

 

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30.01.2023 | QUESTION OF THE WEEK

What are the objectives of personnel medical examinations?


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27.01.2023 | NEWS

ICH: Final Publication of Revised ICH Q9 Guideline

ICH: Final Publication of Revised ICH Q9 Guideline

The International Council for Harmonisation (ICH) published a revised version of its Q9 guideline on 20 January, updating the original guideline, which is now 18 years old.


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26.01.2023 | NEWS

USA: Transition to ISO 13485 is getting closer

USA: Transition to ISO 13485 is getting closer

The US government's Office of Information and Regulatory Affairs has issued a timeline for harmonizing, or converting, the 21 CFR 820 with the European ISO 13485 for medical devices.


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24.01.2023 | LOGFILE Feature 3/2023

7 Questionnaire Blocks for PLC User Requirements

7 Questionnaire Blocks for PLC User Requirements

9 min. reading time | by Petra Berlemann and Thomas Peither

 

User Requirements, User Requirements Specification (URS), Specification Sheet

What is it? How do you create such documents? Is it all the same? Or is it something completely different?


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23.01.2023 | QUESTION OF THE WEEK

What is the dual function of protective clothing in pharmaceutical manufacturing?


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10.01.2023 | LOGFILE Feature 1/2023

How to Maintain the Qualification Status of Your Equipment

How to Maintain the Qualification Status of Your Equipment

9 min. reading time |

 

The life cycle of an equipment begins with initial qualification and ends with decommissioning. Once a qualification status has been achieved, it must be guaranteed over the entire life cycle until the equipment is decommissioned.


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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.


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30.01.2023 | QUESTION OF THE WEEK

What are the objectives of personnel medical examinations?


read more ...
26.01.2023 | NEWS

USA: Transition to ISO 13485 is getting closer

USA: Transition to ISO 13485 is getting closer

The US government's Office of Information and Regulatory Affairs has issued a timeline for harmonizing, or converting, the 21 CFR 820 with the European ISO 13485 for medical devices.


read more ...
23.01.2023 | QUESTION OF THE WEEK

What is the dual function of protective clothing in pharmaceutical manufacturing?


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 ...
27.01.2023 | NEWS

ICH: Final Publication of Revised ICH Q9 Guideline

ICH: Final Publication of Revised ICH Q9 Guideline

The International Council for Harmonisation (ICH) published a revised version of its Q9 guideline on 20 January, updating the original guideline, which is now 18 years old.


read more ...
24.01.2023 | LOGFILE Feature 3/2023

7 Questionnaire Blocks for PLC User Requirements

7 Questionnaire Blocks for PLC User Requirements

9 min. reading time | by Petra Berlemann and Thomas Peither

 

User Requirements, User Requirements Specification (URS), Specification Sheet

What is it? How do you create such documents? Is it all the same? Or is it something completely different?


read more ...
10.01.2023 | LOGFILE Feature 1/2023

How to Maintain the Qualification Status of Your Equipment

How to Maintain the Qualification Status of Your Equipment

9 min. reading time |

 

The life cycle of an equipment begins with initial qualification and ends with decommissioning. Once a qualification status has been achieved, it must be guaranteed over the entire life cycle until the equipment is decommissioned.


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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