Drugs are increasingly recalled due to contaminants. Mike Schaefers, West Pharmaceutical Services, discusses how to improve the quality of injectable drug products by minimising and controlling sources of particulates from primary packaging components.
Particulate matter is a key indicator of quality for injectable drug products. An undissolved particle, other than gas bubbles, unintentionally present in a drug product solution is defined in United States Pharmacopeia (USP) as foreign particulate matter.1 Particulates are considered to be a broad category of material that can be either intrinsic to the drug product or extrinsic, which may result from the manufacturing process.
Concerns for patient safety were recognised relative to particulates in parenteral drug products as early as 1940.2,3 The current USP limit for particulate matter was instituted in 1995 and was derived from knowledge based on process capability and methods employed in 1970, which does not reflect the quality concerns for today’s drug products.
The USP methods were initially developed for visible particulates and primarily intended for small molecule drug products. Data mining over a five-year period at the FDA Office of Generic Drugs suggests that the acceptance limits could be lowered, thus increasing drug safety without placing excessive burden on the industry.4
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