July 10th 2025
The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.
Sustainability in Inhalation and Small-Molecule Drugs
January 30th 2025Pharmaceutical Technology® spoke with Andy Burns, vice president, MDI Business Development at Kindeva, about how sustainability requirements are impacting contract development and manufacturing organizations, specifically for the development and manufacture of inhalation drugs.
Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging
January 23rd 2025Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on how to respond to defective vials in a batch and how to prevent future problems in secondary packaging.
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
The Impact of USP Chapter <86> on Endotoxin Testing
December 11th 2024Pharmaceutical Technology® spoke with Nicola Reid, Associate Director Product Management, Endotoxin Products at Charles River Laboratories, to get her perspective on endotoxin testing and USP’s new Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents.
Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications
December 10th 2024This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.