ASTM WK67425

    New Practice for Standard Practice Guide for the Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

    (What is a Work Item?)

    Developed by Subcommittee: E55.03 | Committee E55 | Contact Staff Manager


    1. Scope

    Pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter (OTC), veterinary, biologics, and clinical supplies) and Medical Devices. It is also applicable to other health, cosmetics, and consumer products.


    Cleaning, Validation, Visual, Inspection, VRL


    Visual Inspection has been used to release manufacturing equipment and Medical Devices for use after cleaning for many years in the Pharmaceutical, Biologics and Medical Device industries; however, Visual Inspection has never been demonstrated to be effective, reliable or safe to use. Recently the European Medicines Agency (EMA) issue a Q&A to their Guideline on Determining Health Based Exposure Limits where they described what criteria had to be met for Visual Inspection to be acceptable to the EMA for relrease of manufactring equipment. Consequently, a Standard is needed to guide these industries in demonstrating that inspectors are capable and qualified to accurately assess the absence or presence of residues of manufacturing equipment or Medical Devices.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:

    Technical Contact:
    Andrew Walsh