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

Particles in Parenterals: 2019 Update

FDA expects a visual inspection program and parenteral manufacturers should expect questions about their program during any inspection. What's new in 2019?

Visible Particulate FDA Recall Notices by year as compiled by John Shabushnig, Insight Pharma Consulting, from FDA data. Reprinted with permission.
Visible Particulate FDA Recall Notices by year as compiled by John Shabushnig, Insight Pharma Consulting, from FDA data. Reprinted with permission.

Visual inspection of parenteral drug packaging remains a priority for manufacturers and the FDA, as explained by John Shabushnig, PhD of Insight Pharma Consulting and Richard Watson of Merck at the 2019 Parenteral Drug Association (PDA)/FDA Join Regulatory Conference held in Washington D.C. in Sep. 2019. Shabushnig monitors FDA recall notices, filtering on those that are due to visible particulate in parenterals.

Counting recall notices can be a little misleading because one notice can be for a single lot, or it can be for multiple lots and even multiple products, but it still offers a way to easily measure the frequency of occurrence of a given type of defect. In recent years, the number of recalls listed by the FDA for visible particles has been significantly lower than the spikes seen in 2013 and 2014. The trend for 2019 so far is comparable to recent years. Of course, the goal is zero defects.

According to Watson, most particulate found in parenterals is simple lint, but other types include glass delaminations, plastic, metal and stopper particles. In 2014, after heightened attention was placed on this issue by the regulators and industry, US Pharmacopoeia published new visual inspection guidance known as USP 790. Shabushnig attributes the drop in particulate recalls starting in 2015 to that attention and the new guidance.

Break out of the ordinary: see what’s new in life sciences packaging
<strong>At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us in September to experience a breakthrough for life sciences products.</strong>
REGISTER NOW & SAVE!
Break out of the ordinary: see what’s new in life sciences packaging
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