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, the final item is one close to my heart, documentation being the backbone of all GMP activities. Who hasn’t heard that old adage…
A review of the draft update to EU and PIC/S Annex 11 Computerised Systems Can you remember what mobile phone you had in 2011? Was it even a smart phone? And now can you imagine how your life would work without one? And yet in that time the Good Manufacturing Practice (GMP) annex that dictates…
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…
Fast-Tracking Innovation: What the FDA’s New Commissioner’s National Priority Voucher (CNPV) Program Means for Pharma in 2025 The US’s turbulent political situation has been impacting the therapeutic drug industry on a global scale for a number of months. Initiatives such as the FDA reforms and trade tariffs have created significant uncertainty for manufacturers across the…
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