30.01.2023
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QUESTION OF THE WEEK
GMP:Blog
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27.01.2023
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NEWS
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 ...
26.01.2023
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NEWS
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 ...
24.01.2023
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LOGFILE Feature 3/2023
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 ...
23.01.2023
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QUESTION OF THE WEEK
10.01.2023
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LOGFILE Feature 1/2023
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 ...
10.06.2021
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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 ...
01.01.2021
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AUTHOR
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 ...
01.09.2020
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ASK OUR EXPERTS
Late, but not too late? How to best define the final time point of a stability study?
30.01.2023
|
QUESTION OF THE WEEK
26.01.2023
|
NEWS
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
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 ...
01.01.2021
|
AUTHOR
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
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
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
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 ...
01.09.2020
|
ASK OUR EXPERTS
Late, but not too late? How to best define the final time point of a stability study?