Ever since the development of the earliest intravenous therapies, the presence of particulate matter in injectable drug products has been a concern among clinicians.
In recent years, there has been an increase in the number of drug product recalls due to the presence of particulate matter.
These recalls are actions taken by a company to remove a product from the market. A manufacturer recalls a product voluntarily, by request from the U.S. Food and Drug Administration (FDA) or by FDA order under its statutory authority.
In 2007, reported cases of glass particles found in drug products spurred closer examination of particulates and their possible sources. Particulates found in injectable drugs can include fibers, metals, rubber, glass and even precipitates related to drug products themselves. Particulate matter originating from packaging materials and components has emerged as the major source of particulates in drug products.
While some particles are considered “extrinsic” (i.e., can enter the manufacturing process from outside sources, including personnel), others are “intrinsic” to the manufacturing process specific to a drug product.
Since 2008, there has been heightened attention among manufacturers and regulators on particulate matter detection and control.
With current manufacturing capabilities, it is not possible to manufacture injectable drug products that are completely free of particulates. Thus, minimizing their presence during the manufacturing process is a critical step in reducing their presence in the final drug product, which is a critical factor for the health care professional, the manufacturer and the regulator—and ultimately, the patient.
In August of 2014, a new standard for visible particulate matter—General Chapter <790>—became official in USP’s compendia of public standards, U.S. Pharmacopeia—National Formulary.
With an increasing level of global sourcing and distribution of drug products, attention to the presence and control of particulate matter is more important than ever. Manufacturers must develop and maintain a keen awareness of where their manufacturing processes are most vulnerable to particulate contamination.
In 2014 the USP and FDA, with the help of Roy Cherris and his colleagues, developed General Chapter <1790>, Visual Inspection of Injections. This standard is designed to give a comprehensive life-cycle approach for understanding particulate matter, where it can come from and how to control it.
InQuest Science's CSO, Roy Cherris is one of the co-authors of Visual Inspection and Particulate Control. This book was published in 2016 and has provided technical insight to hundreds of big through mid-sized sterile, parenteral, ophthalmic or biotechnology companies. Including small to virtual clinical product development organization, contract manufacturing, compounding pharmacies, medical device, primary component and API manufacturers. The life-cycle approach to management of visual inspection, particulate and physical defect control, described in the book, is supported by FDA, USP-1790 and PDA TR-79 guidance.
InQuest Science's Identifier Software is the missing piece to the integrated life-cycle approach.