Newsletter | July 23, 2026

07.23.26 -- 7 Facilities Pilot PreCheck For Faster Approval

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INDUSTRY INSIGHTS

Scaling Manufacturing Flexibility For Fill-Finish Commercial Success

Pharma and biotech developers rely on adaptable fill‑finish capacity to meet evolving market demands, scale products from clinical to commercial, and respond rapidly to public‑health emergencies.

Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?

Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

Unleash The Potential For Polyvinyl Alcohol In Spray Drying

See how polyvinyl alcohol addresses key formulation challenges in oral solid dosage forms to enhance solubility and stability across diverse APIs, which include emerging drug classes like PROTACs.

FROM THE EDITOR

7 Facilities Pilot PreCheck for Faster Approval

A more streamlined path to operational new pharmaceutical facilities in the U.S. may be on the horizon. Nearly a year after the PreCheck Pilot Program was introduced by the U.S. Food and Drug Administration (FDA) in August 2025, the first seven participating facilities have been announced.

INDUSTRY INSIGHTS CONTINUED

Scale-Up And BLA Planning For Microbial Biomanufacturing

Early planning for scale-up and biologics license application activities can maximize your chances of success by allowing sufficient time to develop launch options and prevent costly delays and setbacks.

Lighthouses, Lean, And The Human Factor In Digital Transformation

Explore the evolution of digital manufacturing, the enduring value of human judgment, and the balance between innovation and regulation with practical insight into where modern operations are headed.

A Closer Look At Inspection Systems In Tablet And Capsule Production

Walk through the rigorous inspection process pharmaceutical products undergo to ensure safety and quality, from granulated ingredients to packaging.

Innovations In Peptide Manufacturing

The peptide manufacturing industry is evolving to meet the demands of efficiency, scalability, and sustainability. Learn how the latest innovations are addressing these challenges.

Be Smart: Flexible Production With Module Type Package (MTP)

Modular production is moving from vision to practice. Examine how the Module Type Package enables flexible manufacturing while unlocking valuable process data based on real implementation experience.

Enhancing Novel Developability Through Automated MS Analytics

Growing biotherapeutic complexity demands MS workflows that can unify diverse datasets. Observe how automated approaches enhance data quality, streamline analysis, and support faster development.

Immediate Benefits Of Real-Time Microbial Monitoring

Airborne microbial contamination is a serious concern for companies producing medicines and biotech products, and it must be addressed to ensure that products and people are kept safe.

Revolutionizing Pharma Validation With AI

Validation in GxP environments is often the bottleneck in digital transformation—manual, repetitive, and complex. One company's Intelligent Agents are transforming that process.

GLP-1 OSD Chemical Synthesis Workflow

Enhance containment and process reliability in oral GLP-1 synthesis. Discover how integrated single-use assemblies and automated fluidics safeguard chemical purity during scale-up.

Mixing Technology Considerations For The Cannabis And CBD Industries

Gain insight into an array of mixers and mixing technologies that can help you throughout the cannabis product manufacturing process.

Scientific Data Is Not AI‑Ready By Default

Convert siloed laboratory data into trusted, AI-ready assets. Enforce data integrity principles at the point of origin to streamline analytics and reduce GxP compliance risks.

Quality By Design: The Future Of Automated Pharmaceutical Labeling

Delve into how applying Quality by Design principles to automated labeling platforms utilizes robotics to eliminate manual errors and seamlessly adapt to future pharmaceutical packaging formats.

Startup Decision Guide: Right-Size Your Life Science QMS

Evaluating quality frameworks requires balancing immediate compliance with long-term scalability. Find out how to analyze organizational maturity and regulatory demands to select an optimal system.

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Explore the Industry’s Most Pressing Topics

The 2026 ISPE Annual Meeting & Expo brings together pharmaceutical and biopharmaceutical professionals to tackle the industry's biggest opportunities and challenges. Through five conference tracks—Digital, Data, and Decision Integrity; From Breakthrough to Bedside; Governance, Risk, and Readiness; People, Capability, and the Workforce of Delivery; and Systems That Deliver Reliably—attendees will gain practical insights into AI, advanced manufacturing, quality, sustainability, regulatory trends, and workforce transformation. LEARN MORE

SOLUTIONS

Expertise In Solid Oral Dose Contract Manufacturing And Packaging

Supporting Your ADCs With Proven Payload And Linker Manufacturing

Reliable Filling Process. Easy, Ready-To-Use Products

Pharmaceutical Encapsulation Change Parts And Kits Catalog

Establishing A Container Closure System

Small Molecules Discovery

AI-Enabled Route Scouting Service

A New Era In Aseptic Filling

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