A practical preparation guide for EU CGT sites facing a first FDA PAI/PLI. Learn what changes vs EMA, where inspections start, and how to prioritise evidence, investigations, CAPA effectiveness, data credibility, and sterility assurance.

The New Context for European Biopharma The global manufacturing landscape is shifting. The current U.S. administration continues to promote domestic production, and the FDA has introduced initiatives such as the FDA PreCheck Program to accelerate qualification of U.S.-based sites and reduce offshore dependence. Not every company will relocate manufacturing to the United States. Many European

In today’s biopharma, biologics, and cell & gene therapy (CGT) landscape, mergers, acquisitions, and strategic investments move fast — often faster than the time it takes to truly understand a site’s GMP maturity. That’s where GMP due diligence audits come in.They’re commissioned by investors, private-equity firms, or acquiring companies to assess the real condition of

Artificial Intelligence is no longer a distant concept — it’s entering every corner of biopharmaceutical manufacturing.From process monitoring to deviation analysis, the potential is enormous.Yet, when it comes to AI in Biopharma Quality, many organizations are still hesitant.How can we adopt AI safely, without compromising compliance, trust, or scientific rigor?This article explores where regulators stand

For many Biologics and ATMP companies, the transition from clinical to commercial supply is the moment of truth. And too often, the bottleneck is not science, manufacturing capacity, or even funding. It is the Quality Management System (QMS) and QMS Simplification. In early stages, companies usually grow their QMS reactively: borrowing SOPs from partners, adopting

In biopharma, delayed batch release is more than an operational frustration — it’s a red flag for systemic quality issues. Yet many leaders misdiagnose the problem. They hire more reviewers, tweak templates, or push teams harder. The result? Timelines stay long, morale drops, and compliance risk increases. At GMP Bridge, we’ve seen this pattern across

Quality can’t be a spectator in strategy.Yet in too many organizations, QA leadership in biopharma is still treated as the team of “no” — consulted late, looped in last, and left to fix problems after the fact. This isn’t just inefficient. It’s a risk to compliance, business continuity, and patient safety. Introduction: From Gatekeeper to

Starting as a quality leader in biopharma is one of the toughest—and most rewarding—roles in the industry. Your first 100 days will shape visibility, credibility, and the quality culture you’ll be able to build. This isn’t about fixing everything at once. It’s about building visibility, trust, and credibility fast. Here are 5 proven steps that