MediLedger Product Verification Solution, a DSCSA compliant platform, is announced that will assist drug supply chain stakeholders in product verification and authenticity.
US FDA initiates a pilot project testing innovations in an aim to inform the development of the tracking and verification systems going into effect with the DCSA in 2023.
The European Medicines Agency (EMA) stressed the potential benefits of continuous process validation in guidance issued this week and underlined that data submitted by drugmakers must demonstrate the adequacy of production operations at each site.
The US FDA and European Medicines Agency (EMA) is now offering additional joint guidance on the concept of quality-by-design (QBD) that focuses mostly on design space verification.
The European Medicines Agency (EMA) is looking to integrate guidance from the International Conference on Harmonization (ICH) and US Food and Drug Administration (FDA) into the revisions of two annexes related to its process validation and good manufacturing...
D3 Technology hopes its new SERS-based cleaning verification test, that follows FDA guidelines, will prove attractive to drugmakers looking to expedite the cleaning process and cut downtime between production runs.
