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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.
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.
9 min. reading time | by Petra Berlemann and Thomas Peither
What is it? How do you create such documents? Is it all the same? Or is it something completely different?
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.
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.
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.
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.
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.
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.
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.
9 min. reading time | by Petra Berlemann and Thomas Peither
What is it? How do you create such documents? Is it all the same? Or is it something completely different?
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.