Newsletter | September 30, 2025

09.30.25 -- FDA Launches PreCheck Program

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INDUSTRY INSIGHTS

Guide To Product Inspection Systems In The Pharmaceutical Industry

Explore the critical role of inspection systems, specifically metal detectors, X-ray systems, and checkweighers, in pharmaceutical manufacturing.

A Journey To Boundless Automation In Life Sciences

Boundless automation reimagines industrial computing through seamless integration of the intelligent field, edge, and cloud, unified by a real-time data fabric that enables digital transformation.

Top Safety Considerations In Biopharmaceutical Manufacturing

Understanding top safety concerns, from combustible material handling and chemical exposure to HPAPIs, is the first step toward preventing accidents in biopharmaceutical manufacturing environments.

FEATURED EDITORIAL

FDA Launches PreCheck Program

The program introduces a two-phase approach to enable new U.S. drug manufacturing facilities: The Facility Readiness Phase and the Application Submission Phase.

INDUSTRY INSIGHTS CONTINUED

Navigating The 'Now What' After Early-Phase Success

While moving from early- to late-phase clinical trials is a critical milestone to celebrate on the way to commercialization, many face the same daunting question once the confetti settles ― now what?

Expert Insights On Pharma Analysis And QC

Find responses to the 20 most burning questions surrounding microbial testing, analytical testing,  vaccine development, dissolution testing, method development, data traceability, regulations, and more.

Ensuring IV Bag Sterility With Container Closure Integrity Testing Systems

In the event of an IV bag leak, contaminants can adversely affect the solutions within. Learn how the reference standard for CCIT, USP 1207, applies to the CCIT inspection method of IV bags.

Contamination Control Strategies For Gene Therapy Manufacturing

Gene therapy manufacturing demands a careful balance between contamination control and efficiency. A strategic approach to “critical aseptic” designation is essential to meet evolving regulatory challenges.

5 Must-Haves For Electronic Batch Records In Life Sciences

Companies still relying on paper-based manufacturing are falling behind. Discover how digital transformation boosts efficiency, reduces errors, and ensures compliance.

Driving Efficiency In Document Reviews With Structured Content

Watch how integrating an innovative document review platform streamlines workflows, boosts compliance, and cuts review times by 65% from real-world Life Sciences case studies.

Overcoming Industry Challenges With Digital Validation

Uncover the vital yet often unseen role of CDMOs in manufacturing by exploring their validation challenges, regulatory demands, and strategies for maintaining quality, speed, and innovation.

Fundamentals Of Particle Size Analysis

Gain insight into the importance of particle size characterization and the advanced analytical techniques employed to assess micronized particles effectively.

Why A Dynamic, Digital Defect Library Is Now A Regulatory Expectation

Maintaining a dynamic, digital defect library is essential for modern sterile manufacturing. Learn how this approach helps ensure consistency in batch disposition and supports regulatory compliance.

Navigating The Allogeneic Commercialization Journey

Review the pivotal moments, challenges, triumphs, and lessons learned that have shaped an evolution from facility construction to a fully operational, patient-focused CDMO.

Unlock Smart Production: The Key Role Of Checkweighing

In today's fast-paced production, precision checkweighing is crucial. Read how smart algorithms, real-time analysis, and automation optimize performance and minimize downtime.

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Webinar: From Compliance to Confidence: Annex 1 for Small-Batch, High-Value Production

Discover how to navigate GMP Annex 1 updates with confidence in this must-attend webinar. Former MHRA inspector Tracy Moore shares expert guidance on contamination control, monitoring, risk-based compliance, and reject handling for aseptic filling of small-batch, high-value products. Plus, see 3P innovation's live demo of roboFIL®, showcasing advanced automation for smarter, flexible, compliant fill-finish operations. Click here to learn more.

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