GMP:Blog

13.12.2024 | NEWS

WHO: 2 More African Countries Reached Maturity Level 3

The World Health Organisation (WHO) announced that Senegal had became the 7th country and Rwanda the 8th country to achieve the status of a stable, well-functioning regulatory authority for the regulation of medicines in Africa.

13.12.2024 | NEWS

ICH: Updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers

The ICH has published the updated Q9(R1) Annex 1: Q8/Q9/Q10 Questions & Answers (R5) related to ICH Q9(R1) Quality Risk Management (QRM).

10.12.2024 | LOGFILE Feature 25/2024

Physicochemical Monitoring of Pharmaceutical Water

5 min. reading time | by Ruven Brandes and Fritz Röder

How can the quality of pharmaceutical water be monitored?

The quality of pharmaceutical water is defined by a large number of specified parameters. Monitoring is required to ensure that this quality is maintained during operation of the water system. This includes regular physical measurements as well as chemical and microbiological tests. The European Pharmacopoeia specifically mentions microbiological monitoring and the testing of TOC and conductivity.

09.12.2024 | QUESTION OF THE WEEK

How is a physicochemical monitoring program structured?

02.12.2024 | QUESTION OF THE WEEK

Which filters are used in safety cabinets, and which filter tests are to be carried out?

26.11.2024 | LOGFILE Feature 24/2024

Isolators – Design and Application

5 min. reading time | by Richard Denk

Looking at Annex 1, the use of barrier systems such as RABS or isolators is very common. Since Contamination Control Strategy (CCS) requirements are an important part of selecting the appropriate barrier technology, closed RABS or isolators should be preferred.

18.11.2024 | AUTHOR

Our Authors

Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!

25.03.2024 | AUTHOR

PhD Birte Scharf

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.

01.09.2020 | ASK OUR EXPERTS