Quality Systems

The CMA will improve Europe’s manufacturing resilience and lead to greater diversification and reduced reliance on single external suppliers.

Pharmaceutical serialization must evolve from regulatory compliance into operational intelligence, addressing hidden failures like exception overload, certificate expiry, and 3PL complexity.

Quantum chemistry is accelerating drug discovery AI by providing physics-based, reproducible, and scalable data that encodes molecular reality.

Bristol Myers Squibb collaborates with Anthropic to accelerate drug development, manufacturing quality systems, and regulatory documentation via AI integration.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients.

Deborah Smook, co-founder and co-owner of TurboFil Packaging Machines, explains some of the challenges involved with prefilled syringe manufacturing.

The FDA replaced acting heads of its drug and biologics centers, deepening leadership instability that raises concerns for pharmaceutical developers.

This week, the industry saw rapid technological integration on the factory floor, a strategic shift toward globalized development networks, and leadership upheaval at the FDA.

FDA Commissioner Marty Makary resigns amid agency turmoil, staff exodus, pressure over vaccines, rulings on abortion pills, and vaping rules.

This article evaluates a structured, risk-based framework for the development, execution, and life cycle governance of master production and control records and batch production and control records systems aligned with current good manufacturing practice requirements and internationally harmonized pharmaceutical quality system guidance.

This week's roundup features coverage from Excipient World and INTERPHEX, including discussions on proactive risk management, the rise of advanced modalities, and the integration of flexible, tech-enabled infrastructure.

Visual inspection injectable products may be enhanced by the utilization of AI to analyze and link data to identify deviations, trends, or irregularities.

In part 4 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, gives a preview of the workshop, Risk Based Framework for Development of New Excipient Products, at Excipient World 2026.

Virtual control groups, automation, novel excipients, and sustainability are some of the topics covered by PharmTech this week.

Alternative methods to the use of animals in pharmaceutical testing are becoming more used and accepted. Laura Lotfi of Charles River breaks down the basics of virtual control groups in drug development.

In part 2 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains what drives the need for the development of a new excipient and how involved regulators are in the process.

Daniele Ansaldi, technical manager for Automated Inspection Machines at Antares Vision Group North America, outlines some of the challenges of performing visual inspections on prefilled syringes.

This article provides a statistically defensible and GMP-aligned justification for continued IPC reliance on computed net fill weight when equivalence in mean and variance can be demonstrated.

Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how companies can investigate patient complaints involving prefilled syringes and combination products.

Peter Makowenskyj, senior director of Design Consulting at G-CON, and Beata Sweryda-Krawiec, associate director at Boehringer-Ingelheim, discussed trends influencing the design of pharmaceutical manufacturing facilities during a Quick Fire Learning Lab at INTERPHEX 2026.

Panelists at INTERPHEX 2026 talked about the move to hybrid modeling for process development and the barriers to the adoption of artificial intelligence in pharmaceutical manufacturing.

The agency is celebrating the achievement of key first year goals in implementing the Roadmap to Reducing Animal Testing in Preclinical Safety Studies.

Drug shortages are rising. Learn what's breaking the pharmaceutical supply chain, and what industry leaders are doing to fix it.

Rohan Kumar, laboratory analyst at CS Analytical, discusses how sustainability in pharmaceutical packaging can be improved.

This week, PharmTech discussed the use of AI in real-time monitoring, a strategic collaboration in radiopharmaceutical development, and navigating regulatory hurdles.