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Wireless Sensors in a GMP Environment

FDA inspection – 483 citation tracking

FDA Citation Tracking Tool Updated October 2022
I’m excited to share that QikSolve has helped us to update track and trend all the FDA inspection 483 citations from 20011 to 2021, the tool dynamically scrapes data from various live websites …

FDA Metrics tracker

Updated FDA 483 citations analytics tool

This popular blog has been updated in 2022 with the latest FDA data.

As we all know there has been an increasing regulatory emphasis on the importance of Quality Metrics. Where there is a demand, there will also follow a …

Annex-2B-Biologicals

Annex 2B – Manufacture of Biologicals under GMP PE009-015

PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update splits Annex 2 into Annex 2A: Advanced Therapy Medicinal Products and Annex 2B: Biological Medicines separately:

Annex 2A: Manufacture …

annex-2a-manufacture-of-atmps-pics

Annex 2A – Manufacture of ATMPs under GMP PE009-015

PE00-015 Guide to Good Manufacturing Practice for Medicinal Products has recently been adopted by the TGA in Australia. Notably, this update separates Annex 2 into advanced therapy medicinal products (ATMP) and biological medicines, as follows:

Annex 2A: Manufacture of …

EudraLex Volume 4 Annexes - Annex 21

EudraLex Volume 4: EU Annex 21 GMP guidelines

EudraLex, Volume 4 – Good Manufacturing Guidelines
European Union: EU GMP Guide Updates – EU Annex 21 (News)

Manufacturers/Importers and Sponsors who import medicinal products into the EU/EEA must now comply with EU Annex 21 GMP requirements.

Background to EU Annex 21 …