Quality Systems

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

Development of the state-of-the-art facility was made possible by a £2 million (US$2.6 million) round of funding, and a successful inspection by MHRA was completed in March 2025.

BDD Opens GMP Manufacturing Facility in Scotland

Videos

Even with, or perhaps because of, the rapidity with which changes in United States policy are developing, many in the bio/pharmaceutical industry are taking a longer view.

Tariff Pause Reinforces Uncertainty Among Biopharma Professionals

As single use becomes more prevalent, end users are looking for more customization, and regulators are refining their rules, says Todd Andrews of CPC in an interview with Pharmaceutical Technology® Group.

INTERPHEX 2025: ‘Breaking Up the Octopus’ of Single-Use Systems

 is a PhD student in the Department of Pharmaceutics, UCL School of Pharmacy, University College London.

 is a professor in the Department of Pharmacology, Pharmacy and Pharmaceutical Technology, University of Santiago de Compostela, honorary lecturer in the Department of Pharmaceutics, UCL School of Pharmacy, University College London, and co-founder of FABRX Ltd and FABRX Artificial Intelligence.

 is a professor in the Department of Pharmaceutics, UCL School of Pharmacy, University College London and co-founder of FABRX Ltd.

3D printing of personalized medications is currently possible under existing compounding regulations, offering enhanced process control through automation. But new legislation coming in 2025 will allow 3D printing as part of a distributed manufacturing framework.

Entering New Domains for 3D Printing of Drug Products

 is product manager, analytical services at Stevanato Group.

 is scientific director at Nelson Labs Europe.

The authors examine the risks of extractables and leachables, and present solutions that emphasize the importance of a strategic, multi-prong approach.

Extractable and Leachable Challenges in Lyophilized Drug Products

Three of the five are biosimilars, and seven additional medicines received recommendations for indication extensions.

EMA Recommends Five New Medicines for Approval

Feliza Mirasol is the science editor for 

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

FDA Issues Warning Letter to Aspen Biopharma Labs for API Manufacturing Deviations

The company’s state-of-the-art sterile drug product manufacturing site in Saint-Beauzire, France, opened in February 2023.

CARBOGEN AMCIS Receives GMP Certification Following Successful ANSM Inspection

Fabhalta (iptacopan) received a positive opinion for treatment of C3G from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and has been approved twice before by FDA.

FDA Approves Novartis Oral Treatment for Adults with C3 Glomerulopathy

The EU medicines agencies’ network strategy, EMANS, is an update of the five-year strategy previously developed to cover the period 2021 to 2025.

Regulatory Oversight and Compliance