The Global Regulatory Village
Harmonization of global regulations fosters innovation and ensures quality medicines.
Artificial Intelligence in Pharmaceutical Manufacturing
FDA is anticipating how AI may advance manufacturing and improve supply chain security.
Master File Submission of Structures
The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions.
Quality Quartets in Risk-Based Qualification:
Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.
ICH Q9: Attaining a Quality-Business Synergy through Quality Risk Management, ROI Analysis, and Highly Capable Facilities
This paper explores the relationship between investing in pharmaceutical manufacturing risk reduction and meeting business objectives.
Knowledge as the Currency of Managing Risk
Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.
Moderating Innovation to Equipoise Risk
As innovation accelerates, pharmaceutical regulators continue their path of maintaining proportion, balance, and restraint.
