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29.11.2021 | QUESTION OF THE WEEK

What is the FDA inspection report being called?


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26.11.2021 | NEWS

EMA: Revision of Q&A on pre-authorisation of centralised procedures

EMA: Revision of Q&A on pre-authorisation of centralised procedures

The European Medicines Agency has revised its 142-page document European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. The publication of 22 November 2021 includes the adjustments already made in October, as well as an update to paragraph 2.9 on the procedural structure of application from November. All changes to the document are marked with a corresponding date reference and concern section 2 "Steps prior to submitting the application".


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23.11.2021 | LOGFILE Feature 44/2021

Responsible Person according to GDP at the Logistics Service Provider

Responsible Person according to GDP at the Logistics Service Provider

8 min. reading time | by Simone Ferrante

 

In Europe, companies with a wholesale distribution authorisation, the management must appoint a responsible person who is responsible for the introduction and implementation of a quality management system and compliance with the GDP rules.


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22.11.2021 | QUESTION OF THE WEEK

What is a black-box test?


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19.11.2021 | NEWS

EMA: Q&As from webinar on EudraGMDP/OMS for veterinary medicines

EMA: Q&As from webinar on EudraGMDP/OMS for veterinary medicines

The European Medicines Agency (EMA) has published a 13-page Q&A including 87 questions and answers from a webinar held on the topic of integrating EudraGMDP and OMS (Organisation Management Services) into the new regulatory framework for veterinary medicines.


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16.11.2021 | LOGFILE Feature 43/2021

Cleanrooms: The Path from Concept to Qualified System

Cleanrooms: The Path from Concept to Qualified System

6 min. reading time | by Harald Flechl

 

Good Engineering Practice (GEP) for procurement

Beginning from the definition of the User Requirements Specification (URS) the planning phase is subdivided into four stages:


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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 ...
29.11.2021 | QUESTION OF THE WEEK

What is the FDA inspection report being called?


read more ...
23.11.2021 | LOGFILE Feature 44/2021

Responsible Person according to GDP at the Logistics Service Provider

Responsible Person according to GDP at the Logistics Service Provider

8 min. reading time | by Simone Ferrante

 

In Europe, companies with a wholesale distribution authorisation, the management must appoint a responsible person who is responsible for the introduction and implementation of a quality management system and compliance with the GDP rules.


read more ...
19.11.2021 | NEWS

EMA: Q&As from webinar on EudraGMDP/OMS for veterinary medicines

EMA: Q&As from webinar on EudraGMDP/OMS for veterinary medicines

The European Medicines Agency (EMA) has published a 13-page Q&A including 87 questions and answers from a webinar held on the topic of integrating EudraGMDP and OMS (Organisation Management Services) into the new regulatory framework for veterinary medicines.


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 ...
26.11.2021 | NEWS

EMA: Revision of Q&A on pre-authorisation of centralised procedures

EMA: Revision of Q&A on pre-authorisation of centralised procedures

The European Medicines Agency has revised its 142-page document European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure. The publication of 22 November 2021 includes the adjustments already made in October, as well as an update to paragraph 2.9 on the procedural structure of application from November. All changes to the document are marked with a corresponding date reference and concern section 2 "Steps prior to submitting the application".


read more ...
22.11.2021 | QUESTION OF THE WEEK

What is a black-box test?


read more ...
16.11.2021 | LOGFILE Feature 43/2021

Cleanrooms: The Path from Concept to Qualified System

Cleanrooms: The Path from Concept to Qualified System

6 min. reading time | by Harald Flechl

 

Good Engineering Practice (GEP) for procurement

Beginning from the definition of the User Requirements Specification (URS) the planning phase is subdivided into four stages:


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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