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…
The International Council for Harmonisation’s (ICH) formally adopted the ICH Good Clinical Practice (GCP) E6(R3) guideline on January 6, 2025, marking the most significant evolution in clinical trial standards in nearly a decade. This comprehensive revision introduces notable changes to sponsor responsibilities while emphasising quality management, risk-based approaches, and enhanced oversight requirements. Understanding these changes…
Pharma & Device Forum – Education Sessions On the 31st of March and 1st of April 2025, ~ 250 life science professionals, including those from the pharmaceutical industry, laboratory sciences/research sectors, quality management, operations management, and medical devices sectors, came together in Melbourne for the 14th ‘GMP Forum’ (the 2025 Pharma & Device Forum organised…
The future of pharma & medical device manufacturing is already here, and what’s not here yet is rapidly unfolding. There’s a lot to take in this year in terms of industry trends, new technologies, and GxP & GMP compliance guidelines for pharmaceutical and medical device organisations! It would be nice if the latest AI technologies…
Cosmetic Product Registration Rules (United States FDA) US laws governing the cosmetic industry changed significantly in recent years. The ‘Modernization of Cosmetics Regulation Act’ (MoCRA) placed new requirements on manufacturers and distributors of cosmetic products in the United States (US). This is Part 2 of FDA compliance resources for cosmetic product regulations (MoCRA). Key components…
As of 1 October 2024, the Pharmacy Board of Australia’s Guidelines on Compounding of Medicines have been updated, introducing numerous updates, with 51 noticeable key changes that stood out. These updates introduce numerous (>50) changes to provide pharmacists and support staff with more precise guidance on safe compounding practices. The revisions align with evolving healthcare…
In the pharmaceutical and biotechnology industries, cleaning validation is a critical process to ensure that equipment used in manufacturing is free from contaminants that could affect product quality and patient safety. However, there are instances where toxicological data for certain residues may not be available. This blog explores strategies and best practices for conducting cleaning…
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