What Manufacturers Should Do Before the Scope of Annex 15 Expands to APIs The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has opened a public consultation on proposed revisions to Annex 15 (Qualification and Validation) of the PIC/S Good Manufacturing Practice (GMP) Guide. Highlighted by the Therapeutic Goods Administration (TGA) in March 2026, the Annex 15 consultation…
Why computerised systems, validation, and “state of the art” expectations now matter more than ever Medicinal gases are gases that fulfil the definition of a medicinal product and are regulated as such under PIC/S GMP Annex 6. They include products such as oxygen, medical air, nitrous oxide, nitrogen, carbon dioxide, gaseous mixtures and anaesthetics, when…
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…
Balancing innovation with regulatory expectations Artificial Intelligence (AI) is revolutionising pharmaceutical manufacturing, enabling predictive analytics, automated quality checks, and real-time decision-making. While these advancements promise efficiency and accuracy, they also introduce new challenges for data integrity—a cornerstone of Good Manufacturing Practice (GMP) and therapeutic product manufacturers must ensure compliance when leveraging AI-driven systems. AI in…
Analysing the implications of the draft Annex 22 for AI integration and digital transformation The pharmaceutical industry is on the brink of a digital revolution, and the draft GMP Annex 22 Artificial Intelligence signals a major shift in regulatory expectations for AI and digitalisation in GMP environments. We have previously reviewed the content of the…
MHRA Updates and Global Alignment for Product Recalls Defective medicinal products are under sharper regulatory scrutiny than ever. In early 2026, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) released an updated Guide to Defective Medicinal Products, signalling a refreshed emphasis on rapid defect detection, structured investigations, and decisive recall process. In Australia,…
Budget Planning for Manufacturers Manufacturers operating in Australia face a continually evolving fee environment, with the Therapeutic Goods Administration (TGA) updating its fees and charges annually through cost‑recovery frameworks. For FY2026, the primary indicators came from the TGA’s 2025–26 proposals and the fee schedules published in mid‑2025. These determine the cost structures applicable from 1…
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