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PHSS News | Open Access | Published 2 July 2026 PHSS is proud to announce bioMérieux as our first Supporting Partner This new initiative launches this month and recognises organisations that have demonstrated sustained support for PHSS and our mission to advance compliant, sustainable healthcare innovation. As an independent, not-for-profit organisation, PHSS works without commercial bias to provide trusted guidance in GMP, regulatory interpretation, and practical implement

Medicines are being developed for diseases that were previously untreatable, and new technologies such as cell and gene therapies, gene editing (ATMPs), Antibody Drug Conjugates (ADCs), and Lipid Nano Particles (LNPs) are providing new ways to target these diseases.

Endotoxin detection is essential in pharmaceutical manufacturing due to the strong pyrogenic activity of lipopolysaccharides (LPS) from Gram-negative bacteria. While the Limulus Amebocyte Lysate (LAL) assay has traditionally served as the reference method, sustainability concerns have driven the development of recombinant alternatives such as recombinant Factor C (rFC). This study compared the performance of an rFC assay with five LAL methods (three KCA and two KTA) using

Changing rooms act as critical control points within pharmaceutical manufacturing facilities, functioning as microbial airlocks that limit personnel‑borne contamination entering classified processing areas. This study presents a five‑year comparative analysis (2022–2025) of microorganisms recovered from changing rooms and adjacent corridors, spanning cleanroom Grades D, C, and B.

July 2026 EJPPS Volume 31 Issue 2 In this volume: Peer Review Papers Impact of Aseptic Dispensing on the Incidence of Nosocomial Infections: A Retrospective Study in a Hospital Characterization And In-Vitro Optimization Of Caffeine-Incorporated Mucoadhesive Microsphere Expanding test panels for pharmaceutical microbiology: Making an informed decision Beyond Threshold Monitoring: A Bayesian and Time Series Framework for Predictive Contamination Control in Aseptic Manufacturing

PHSS News | Open Access | Published 2 July 2026 PHSS News Dear Members, As we head into the summer, we continue to focus on bringing our membership educational and knowledge development opportunities. In April we hosted the 2 day virtual Aseptic workshops, supported by Di Morris, Matt Cokely and David Collins. Day One: Di Morris - PNR Pharma introduced the session, explaining the challenges and high-risk areas of aseptic processing. Matt Cokely and David Collins - Ecolab Life

Review of Developments in GMP and the Regulation of Medicines June 2026 EJPPS Volume 31.2C INTRODUCTION The topics covered in this edition of the “Update” have come from the UK, EU, USA & Australian regulatory authorities. UK Medicines and Healthcare products Regulatory Agency (MHRA) · UK-wide consultation on redefining gene therapies · MHRA invites views on proposed changes to medical device regulation · MHRA supports Northern Ireland life sciences sector

Review of Developments in GMP and the Regulation of Medicines May 2026 EJPPS Volume 31.2B INTRODUCTION During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the UK, EU, USA, Swiss and Australian regulatory authorities. The topics covered in this edition of the “Update” include: UK Medicines and Healthcare products Regulatory Agency (MHRA) · MHRA delivers its targets to

Review of Developments in GMP and the Regulation of Medicines April 2026 EJPPS Volume 31.2A The topics covered in this edition of the “Update” have come from the UK, EU, USA Swiss and Australian regulatory authorities. UK Medicines and Healthcare products Regulatory Agency (MHRA) · Joint Statement from the UK Space Agency, the Medicines and Healthcare products Regulatory Agency, the Regulatory Innovation Office and the Civil Aviation Authority · Man jailed for te

Changing rooms act as critical control points within pharmaceutical manufacturing facilities, functioning as microbial airlocks that limit personnel‑borne contamination entering classified processing areas. This study presents a five‑year comparative analysis (2022–2025) of microorganisms recovered from changing rooms and adjacent corridors, spanning cleanroom Grades D, C, and B.