What’s coming for PQS, documentation and validation The European Medicines Agency (EMA) has published its three‑year GMP work plan for the Good Manufacturing and Distribution Practice (GMDP) Inspectors Working Group covering January 2026 to December 2028. While the document itself is not legislation, it provides one of the clearest forward‑looking signals of how EU Good…
A practical EUDAMED data readiness playbook for manufacturers For many medical device and in vitro diagnostic (IVD) manufacturers, European Database on Medical Devices (EUDAMED) has sat in the background for years, technically available, often partially used, and sometimes deferred in favour of national systems. That period is coming to an end. From 28 May 2026,…
The Next Regulatory Alignment Wave Global Good Manufacturing Practice (GMP) expectations are entering a new phase of GMP convergence. Regulatory across the Pharmaceutical Inspection Co‑operation Scheme (PIC/S) and the European Union (EU) have signalled a clear direction of travel: validation, data integrity, and computerised systems are no longer treated as parallel disciplines – they are…
Navigating Medical Device Regulation Revisions and New Harmonised Standards The global medical device and in vitro diagnostics (IVD) sector is entering 2026 amid one of the most significant regulatory transformations since the introduction of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation (MDR/IVDR). The European Commission and expert bodies have recently released…
For therapeutic goods manufacturers, regulatory change is constant. An effective regulatory intelligence capability ensures you detect, analyse, and operationalise updates across jurisdictions (FDA, EMA/EU GMP, PIC/S, TGA, WHO) before inspections or market events force reactive action. Regulatory intelligence connects horizon scanning with change control, training, supplier oversight and validation so your Pharmaceutical Quality System (PQS)…
Global pharmaceutical manufacturing operates across multiple regulatory frameworks. While core Good Manufacturing Practice (GMP) principles are convergent, there are meaningful differences in structure, terminology, annex coverage and enforcement between the FDA Code of Federal Regulations 21 CFR Parts 210/211, the EU’s EudraLex Volume 4, and Pharmaceutical Inspection/Cooperation Scheme’s PIC/S PE 009-17. This blog details key…
Navigating the 2024 UK Post-Market Surveillance Amendments for Medical Devices In a significant step toward strengthening patient safety and aligning with global best practices, the UK government introduced the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368). These regulations, which amend the UK Medical Devices Regulations ,2002, came into force on…
Introduction For anyone involved in the manufacturing of sterile medicinal products, the recent PIC/S GMP version 17 Annex 1 guidelines are nothing short of a bible. They delineate the rigorous standards necessary to maintain product sterility. One such crucial aspect outlined in these guidelines is cleanroom monitoring. In this blog, we aim to elucidate the…
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