Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

Industry Reacts to FDA Draft Guidance on Injectable Products Inspection

Pharmaceutical companies and the International Society for Pharmaceutical Engineering want the FDA to align visible particle classifications and inspections with USP.

Recipharm Pic

The FDA draft guidance for manufacturers on developing and implementing particle control programs for injectable products, which was issued following numerous recalls due the particulate contamination of injectable products and the agency’s concern for patient safety, has prompted quick reactions from several pharmaceutical companies and industry groups.

A key point of concern is how the guidance defines inherent, intrinsic, and extrinsic particulates, in that the definition doesn’t completely match with that of the US Pharmacopoeia (USP).

According to a recent article published by the Regulatory Affairs Professionals Society, drug makers and pharmaceutical industry groups, including the International Society for Pharmaceutical Engineering (ISPE), Boehringer Ingelheim, and Novartis, want the FDA to align its classification categories for visible particles with (USP) Chapter 1790, “General Chapter Visible Particulates in Injections,” which defines particle categories and describes inspection procedures used to demonstrate injectable products are essentially free from particulates.


Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report
Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Researched List: Blister Machines for Life Sciences