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EJPPS Volume 30 Issue 4
December 2025 EJPPS Volume 30 Issue 4 In this volume: Peer Review Papers Protective Airflow in Aseptic Manufacturing: Ensuring First Air Integrity Feasibility assessment of recombinant reagents for the application of endotoxin testing of pharmaceutical waters Performance of Cleanroom Garment Fabrics When Processed in an Industrial Laundry: Cleanroom Undergarments and Non-Sterile Outer Garments Importance of the Endotoxin Standard in the LER Hold-Time Study Finding an accurate
lauraclark849
Dec 19, 20251 min read


PHSS News - Winter update 2025
PHSS News | Open Access | Published 18th December 2025 PHSS News Dear Members This year seems to have flown by; we are now approaching the close of 2025. We have hosted six fantastic events across the year, bringing together the membership, valuable partners and industry from the 2-day Aseptic Workshop in March, through to the most recent Scientific Insights webinar in November. We are focused on providing many ways to engage and share knowledge. In addition to the core
tamsinmarshall4
Dec 18, 20252 min read


GUEST EDITORIAL: Chris Morgan - Our Industry is Evolving
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.
tamsinmarshall4
Dec 18, 20255 min read


Regulatory Update: December 2025
Review of Developments in GMP and the Regulation of Medicines December 2025 EJPPS Volume 30.4C 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 and Swiss regulatory authorities. The topics covered in this edition of the “Update” include: UK Medicines and Healthcare products Regulatory Agency (MHRA) · Three convicted in major MHRA inve
lauraclark849
Dec 15, 202513 min read


Regulatory Update: November 2025
Review of Developments in GMP and the Regulation of Medicines November 2025 EJPPS Volume 30.4B 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, Australia and PIC/S regulatory authorities. The topics covered in this edition of the “Update” include: UK Medicines and Healthcare products Regulatory Agency (MHRA) · Regulation in an age of per
lauraclark849
Dec 15, 202517 min read


Regulatory Update: October 2025
Review of Developments in GMP and the Regulation of Medicines Oct 2025 EJPPS Vol 30.4A 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, Australian Swiss and USA regulatory authorities. The topics covered in this edition of the “Update” include: UK Medicines and Healthcare products Regulatory Agency (MHRA) · Medicines that you cannot export from the UK
lauraclark849
Dec 15, 202512 min read


Microemulgel - A promising novel formulation for topical drug delivery
Technical Review Article | Open Access | Published 18th December 2025 Microemulgel - A promising novel formulation for topical drug delivery Gupta Ashish¹, Darwhekar Gajanan¹, Jain Sachin Kumar² | EJPPS | 304 (2025) https://doi.org/ 10.37521/ejpps30406 Back to Journals | Article |Abstract | References | Authors Abstract Microemulgel is a new and promising drug delivery system employed in the pharmaceutical industry. It is a stable dispersion consisting of an oi
lauraclark849
Dec 9, 202523 min read


Microneedle: An Emerging Technique of Drug Delivery System
Polysorbates (PS), particularly polysorbate 20 (PS20) and polysorbate 80 (PS80), are widely utilized as non-ionic surfactants in biopharmaceutical formulations. Their primary role is to stabilize therapeutic proteins against interfacial stresses encountered during manufacturing, handling, and storage. Despite their widespread use, PS are complex and heterogeneous mixtures prone to degradation. The two primary degradation pathways are hydrolysis and oxidation. Hydrolytic degra
lauraclark849
Dec 9, 202519 min read


Analytical Method Development for related substances (Organic impurities) in Pharmaceuticals: A Comprehensive review of Methodologies and Regulatory Compliance
Technical Review Article | Open Access | Published 18th December 2025 Analytical Method Development for related substances (Organic impurities) in Pharmaceuticals: A Comprehensive review of Methodologies and Regulatory Compliance Sumeet Dwivedi¹*, Rajesh Kumar Chawla², Naresh Ambekar². | EJPPS | 304 (2025) https://doi.org/10.37521/ejpps30407 Back to Journals | Article |Abstract | References | Authors Abstract The terms "related substances" and "organic impurities"
lauraclark849
Dec 9, 202521 min read


Finding an accurate equation to estimate the osmolarity of parenteral nutrition for preterm baby
Peer Review Article | Open Access | Published 18th December 2025 Finding an accurate equation to estimate the osmolarity of parenteral nutrition for preterm baby Suci Hanifah | EJPPS | 304 (2025) | https://doi.org/10.37521/ejpps30405 Back to Journals | Abstract | Conclusion | References | Authors Abstract Background: Determining the osmolarity of parenteral nutrition (PN) preparations is essential to guide the administration route—whether via peripheral or cent
lauraclark849
Dec 9, 202512 min read
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