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…
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…
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…
Skills to Develop in 2026 It’s not often that I quote Soviet reformers, but today’s idiom is “If you don’t move forward, sooner or later you begin to move backward”. Thanks, Mikhail. Never has that ethos been truer than with the advent of Artificial Intelligence. Already I am surprised when I find clients are not…
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…
Pharmaceutical Manufacture in the New Era of AI Do you remember where you were when… the Berlin Wall fell? … Southeast Asia was struck by the tsunami? …a pandemic was declared for COVID-19? And what about when ChatGPT was released to the public? Whilst not as dramatic as the above events, in the short time…
A number of additions and updates were recently published for EudraLex Volume 4 – Good Manufacturing Practice Guidelines for stakeholder consultation, including Revision of Chapter 4 Documentation and: As a technical writer, this Chapter 4 change is one close to my heart, documentation being the backbone of all GMP activities. Who hasn’t heard that old…
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