![]() ![]() The lower limit of the visible range is assumed to be 100 µm, but varies depending on product container, nature of the drug product, and particulate matter properties (color, shape, refractive index). The subsequent acceptable quality level (AQL) inspection must be performed manually. The initial 100% inspection can be automated, manual, or semi-automated. Per USP Chapter, all products must be visually inspected for the presence of particulate matter. Containers that show the presence of visible particulates must be rejected. ![]() Each final container should be inspected for particulate matter, as defined in Chapter Visible Particulates in Injections. ![]() United States Pharmacopeia (USP) Chapter Injections and Implanted Drug Products (Parenterals)-Product Quality Tests states that injectable drug preparations should be designed to exclude particulate matter as defined in USP Chapters Subvisible Particulate Matter in Therapeutic Protein Injections, Particulate Matter in Injections, and Particulate Matter in Ophthalmic Solutions. If injected, they can cause inflammation, tissue damage, or allergic or immunogenic reactions. Particulates, if present, can interact with the injectable drug product and change the chemical consistency. Requirements include being essentially free of visible particulates. Current guidance on analytical methods and particulate matter limits in injectable drug products are published in national and regional pharmacopeias. Injectable drug products have rigorous requirements for the presence of both visible and subvisible particulates. This blog describes approaches to control and measure particulate matter. Particulate matter in finished drug products can come from a number of sources, including the ingredients in the drug product, manufacturing equipment and environment, or the components of the container closure system. One aspect of this is controlling particulate matter. With that, drug product manufacturers face increased pressure to minimize rejects of finished drug products. Novel drug products such as cell and gene therapies have a very high value and therefore each dose is precious. Regulatory and market expectations constantly increase. Regulatory guidance on particulate matter in injectable drugs
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