Nipro Vialex – 26th January 2025
PCI – 7th June 2024
Temax_Krautz

Current Edition

Nasal & Pulmonary Drug Development
Novo Nordisk 20 March 2024, 11:21
Carterra – 24th March 2025

Elemental Impurity Analysis in Pharmaceuticals – The Road To Implementation of ICH Q3D

As of 1st June 2016, all EU marketing authorisation applications for new pharmaceutical products or new products containing an established active substance must now comply with the requirements of ICH Q3D. This includes completing and documenting a risk assessment and having this available for inspection.
At Butterworth, we have been supporting customers in the lead up to these changes providing analysis by ICP, where required, to assist the completion of risk assessments and determine the requirements for ongoing testing. We have also validated excipient, API or product specific methods where elements of concern require routine monitoring.
Download our recent whitepaper to find out more about the key time-frames for implementation in the EU and US and considerations for ensuring compliance.
If you would like to speak to us in more detail about the analytical approaches then please do not hesitate to contact us.
Scott Pharma – 25.03.2025
SMI – 24/03/2025
Chemspec Europe – 27.02.2025
PHARMAP: Mon 14 October 2024, 10.36
FujiFilm Skyscraper: 26th November 2024
Woolcool 26 March 2024, 16:16
Biopharma group 6 March 2024, 09:40
EyeC 18 March 2024, 13:10
L.B. Bohle – 08.04.2025