What Biopharma Often Overlooks In A Scheduled Shutdown

Shutting down an operating biologics facility upsets systems often designed for continuous operation. One expert shares his tips for preventing unnecessary problems.

Achieving Annex 1 Compliance In Sterile Manufacturing, Part 1: Common Compliance Failures

A persistent gap remains between what Annex 1 requires and what facilities can demonstrate. Let's take a closer look at four common compliance failures.

Is Your AI Model Trustworthy And Credible In GMP Processes?

Credibility and trustworthiness in AI models are related but distinct attributes. If you're using them in GMP manufacturing, you should understand the difference.

Unlocking The Full Potential Of Antibody-Drug Conjugates (ADCs)

ADCs are evolving rapidly. Gain insight into how success now hinges on managing complexity, delivery, and scalability to turn promising designs into viable therapeutic products.

Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation

Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

A Comparison Of 6 Analytical Validation Guidelines Using Data Envelopment Analysis

This is the first published application of data envelopment analysis to six major pharmaceutical analytical validation guidelines, including ICH Q2(R2), USP, ChP, and Brazil's ANVISA.

AI Has Arrived In Biotech CMC Amid Patchwork Governance

AI is surfacing within regulatory and CMC workflows at a vigorous pace. Unfortunately, in small and midsize biotechs, it's happening faster than governance can keep up.

What Reliance, Annex 1, And AI Mean For The Future Of GMP

EMA’s Brendan Cuddy explains how regulators are adapting oversight to global supply chains, new technologies, and growing operational complexity.

Will FDA's One-Day Inspection Pilot Stand The Test Of Time?

FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.

Repeating Sanofi's Ballroom Design On Two Continents

Moveable walls and a stunning number of robotics at its sites in France and Singapore, among other features, has earned Sanofi international recognition for innovation.

Why Are Life Science Companies So Poorly Prepared For RIM's Future?

Most organizations have modernized their global regulatory information management (RIM) systems and improved data quality. Yet modernization and readiness are not the same thing.

The Stepwise Path Lilly Mapped From Paper To Digital Logbooks

Eli Lilly and Company started at the front lines, on the shop floor gathering operator input, when switching from paper to digital logbooks.

Minimizing Regulatory Risk For Biologics Manufacturing Changes

Any manufacturing process change for a biologic can raise comparability questions. Here’s a practical, action-oriented strategy to ensure health authorities are satisfied.

Do Changes Signal The End Of Biosimilar Regulatory Redundancy?

First came excitement over the looming patent cliff. Then, FDA and EMA took big swings at what many have called redundant work. Combined, they make a more attractive environment for biosimilar developers.

FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing

The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.

U.S. Pharma Tariffs And MFN Become Law After April 2 Update

Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.

FDA's New Flexible CMC Framework For CGT

The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

How To Implement Post-Approval Changes On A Global Level

To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.

Building Bulletproof Bioprocesses With Equipment Qualification

Consistent equipment performance is critical for compliant biomanufacturing. Learn how lifecycle‑based, risk‑driven qualification strategies can reduce risk and improve efficiency.

UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk

Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.

All The Ways Global Biopharma Still Grapples With Annex 1

Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.

Clearing The Fog On New First Air Visualization Expectations

Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.

Industry Innovators: APAC's Sharp Advanced Therapeutics Edge

APAC is rapidly advancing its role in the global therapeutics landscape, fueled by faster development models. Learn how this momentum is reshaping expectations for innovation and commercialization.

FDA's 483 Playbook: What It Means For Pharma Outsourcing — And What It Doesn't Address

For those involved in outsourcing, the new FDA draft guidance regarding FDA Form 483 observations reshapes the accountability framework. The public comment period ends May 8.

Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables

A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.

Where Contamination Control Really Breaks Down In Practice

Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.

Trends In FDA FY 2025 Warning Letters

The FDA issued a total of 303 warning letters to drug and biologics products in Fiscal Year 2025 (FY25), an increase from FY24. This article reveals key agency focal points and trends.

Stay cGMP Compliant: Instrument Requalification In Pharma

Maintaining equipment is an ongoing GxP requirement. Learn what triggers requalification, why it matters for operational continuity, and how proactive evaluation helps prevent costly disruptions.

5 QMS Blind Spots You Should Know About

Companies often underestimate the complexity of standing up an eQMS. These are five of the most common issues that lead to regulatory and GMP exposure risk.

What To Know About — And How To Apply For — FDA's PreCheck Pilot

FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.