Inspection of Injectable Products for Visible Particulates-Guidance

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This guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination.

The guidance also clarifies that meeting an applicable United States Pharmacopeia (USP) compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (CGMP) requirements for the manufacture of injectable products.

  • “It has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health”(section 501(a)(2)(A)
  • “It is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess” (section 501(a)(2)(B)
  • “It purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in such compendium” (section 501(b)
  • It is a new animal drug that is unsafe within the meaning of section 512 (section 501(a)(5)

Adherence to compendial standards can also assist manufacturers in complying with CGMP requirements (see, e.g., §§ 211.194(a)(2) and 211.165(e)

The clinical manifestations of adverse events caused by particulate contamination vary and may depend on the route of administration (e.g., intravascular, intravisceral, intramuscular), patient population, and nature or class of the particulates themselves (e.g., physical size or shape, quantity, chemical reactivity to certain cells or tissues, immunogenicity, infectivity, carcinogenicity).

During this risk assessment, manufacturers should identify the typical visible particulates that could contaminate the injectable product and characterize their size ranges, quantity, and composition; determine risks for each type; and provide a visual description (e.g., photographs or drawings of typical defects) to be used for training purposes.

Visual inspection can be viewed as part of a larger program to ensure that injectable products are essentially free of visible particulates. During injectable product development, manufacturers should establish procedures for inspecting the product, statistical sampling plan(s), acceptance/rejection criteria, and procedures for evaluating inspection results. Inspection procedures carried over from another site or another product may not always be suitable for a new product.

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    Useful information shared for visual inspection of Injectable products .thank you FWQRC

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