Jessica Tiegs

Senior Regulatory Affairs Specialist

December 03, 2014

Particulate Matter in Injectable Drug Products – What are the Regulations?

As regulatory expectations increase, drug product manufacturers face increased pressure to produce products free of defects and minimize rejects of finished drug products. Particulate matter in finished pharmaceuticals can come from a number of sources, including the ingredients in the drug product, manufacturing equipment or the container closure system.

Regulations, such as USP <1> Injections and <788> Particulate Matter in Injections, have enhanced the complexity and confusion surrounding both visible and subvisible particulate in finished products.  For example, USP <1> Injections states that finished injectable drug products must be “essentially free from visible particulates.”1 It does not, however, clearly define the limitations on the quantity of particulate.  Referenced in USP <1> Injections, USP <788> Particulate Matter in Injections (harmonized with the corresponding European Pharmacopoeia and Japanese Pharmacopoeia text), provides limitations on particle in the ranges of 10 – 25 um and 25 um and greater. 2 More recently, however, USP <790> Visible Particulates in Injection (effective August 2014) provided some clarity to the statement “essentially free” with a more precise finished drug product sampling plan and AQL definition. 3

As a result of these regulations, greater attention to particulate load in the finished injectable drug products has resulted in increased scrutiny of the individual components constituting the packaging system. Pharmaceutical manufacturers can collaborate with packaging suppliers to reduce particulate matter in finished drug products by supplying components with a focus on minimizing loose, embedded and adhered particulate. For these customers, West offers NovaPure® components, developed under the principles of Quality by Design (QbD). West developed these components using a comprehensive quality target product profile that includes industry leading visible and subvisible particle specifications as part of the component critical quality attributes.  In turn, the use of packaging components designed to meet high-quality standards can aid in reducing the risk of rejected drug products.

References:

  1. USP 37 – NF 32. General Chapters: <1> Injections (2014), US Pharmacopeia/National Formulary
  2. USP 37 – NF 32. General Chapters: <788> Particulate Matter in Injections (2014), US Pharmacopeia/National Formulary
  3. USP 37 – NF 32. General Chapters: USP <790> Visible Particulates in Injection (2014), US Pharmacopeia/National Formulary

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