GMP:Blog

24.03.2023 | NEWS

EU MDR/IVDR: New Transitional Provisions Enter into Force

The 6-page amending Regulations (EU) 2023/607 with new transitional provisions for certain medical devices and in vitro diagnostic medical devices was published in the Official Journal of the European Union on 20 March 2023. It entered into force upon publication. This is intended to alleviate supply shortages of important medical devices (we reported). The regulation is binding in its entirety and directly applicable in all member states.

22.03.2023 | NEWS

FDA: Definition Guidance on drug safety in the supply chain

On 16 March 2023, the FDA issued its final guidance on detailed definitions around "suspect products" and "illegitimate products".

20.03.2023 | QUESTION OF THE WEEK

What is the validation of a computerised system?

14.03.2023 | LOGFILE Feature 10/2023

Qualification of Water Supply Systems – Introduction

4 min. reading time | by Fritz Röder

Pharmaceutical water systems are used for a number of different applications by pharmaceutical manufacturers. These include, for example, the cleaning of various pieces of equipment, the generation of pure steam and the use of water as an ingredient for solid, semi-solid and liquid medicinal products.

12.03.2023 | QUESTION OF THE WEEK

What contracts are usually concluded in outsourcing?

01.03.2023 | AUTHOR

Christoph Brewi

01.03.2023 | AUTHOR

Dr. Florian Sieder

28.02.2023 | LOGFILE Feature 8/2023

Document and Evaluate GMP Audit Information and Findings

7 min reading time | by Stephanie Blum, PhD

In the course of an audit, the auditors collect the information necessary to achieve the audit objectives on a sample basis, e.g. by inspecting premises, observing operations, interviewing personnel and examining documents and records. Interviews may be conducted at any time during the audit, including during the walkthrough and review of documentation.

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