Quality Systems

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

Biotech companies and medical product manufacturers have condemned the invasion of Ukraine, while also looking to maintain supplies of essential medicines.

Ukraine Invasion Challenges Biopharma Research and Operations

FDA’s CDER continues to make rare diseases a priority with drug approvals and programming to speed therapeutic development.

FDA Continues to Make Rare Diseases a Priority with Speedy Therapeutic Development

EMA’s PRIME scheme has enabled life-changing medicines to become available to patients at a faster rate.

EMA’s PRIME Enables Earlier Availability of Life-Changing Medicines

MHRA has awarded Promising Innovation Medicine (PIM) designation to rezafungin for the treatment of invasive candidiasis.

MHRA Awards Promising Innovation Medicine Designation for the Treatment of Invasive Candidiasis

Ammar Khawam, PhD, is a senior managing scientist of product development at Parsolex.

Process performance metrics of eight different mechanical devices were assessed to evaluate compliance with regulatory and compendial criteria.

Process Performance as a Means of Quality Management

Courtney Soulsby is sector director, Healthcare & Life Sciences, BSI.

A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines. 


A New Route to Pharma GDP Compliance and Standardization 

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Continuous improvements in technologies and services will help cold chain operators meet future industry demand.

Cold Comfort for Bio/Pharma

Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.

Pfizer Receives FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine Candidate

FDA has approved Vonjo (pacritinib) capsules to treat adults with a rare form of bone marrow disorder.

FDA Approves Drug for Adults with Rare Form of Bone Marrow Disorder

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

The UK’s National AI Strategy underpins the government’s long-term commitment and ambitions to enhancing the country’s digital ecosystem, with the health and life sciences sectors seen as pivotal contributors to meeting these aims.

Regulatory Oversight and Compliance