GMP:Blog

26.05.2023 | NEWS

EDQM: 21st Edition of the Blood Guide Published

The European Directorate for the Quality of Medicines & HealthCare (EDQM) published the 21st edition of the Guideline for the Preparation, Use, and Quality Assurance of Blood Components earlier this month. As a compendium of widely accepted, harmonised European technical standards the guide should provide safety, efficacy, and quality requirements for the preparation, use, and quality control of blood components in Europe and beyond.

26.05.2023 | NEWS

UK and Switzerland Negotiate New Trade Arrangement

According to a press release from the UK government Switzerland and the United Kingdom have started negotiations on a modern and free trade arrangement (FTA) this month.

22.05.2023 | QUESTION OF THE WEEK

What documents are required for operation of a pharmaceutical water system?

16.05.2023 | LOGFILE Feature 19/2023

Biotechnological Medicinal Products: Global Trends and Perspectives

5 min. reading time | by Sabine Paris

The Swiss Biotech Day 2023 took place on 24 and 25 April in Basel. The conference is one of the industry's most important meeting places for developers and manufacturers of biopharmaceuticals and is growing in popularity every year.

15.05.2023 | QUESTION OF THE WEEK

What is the difference between cleanroom class and air cleanliness grade?

02.05.2023 | LOGFILE Feature 17/2023

GMP Compliant Plant Qualification: Software Quality Plan

10 min. reading time | by Petra Berlemann

A software quality plan – what is it and how do you create such a document?

01.03.2023 | AUTHOR

Christoph Brewi

01.03.2023 | AUTHOR

Dr. Florian Sieder

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