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Full Description

This guide applies the life-cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes. It is applicable to pharmaceuticals (including active pharmaceutical ingredients (APIs); dosage forms; and over-the-counter, veterinary, biologics, and clinical supplies) and is also applicable to other health, cosmetics, and consumer products.
 

Document History

  1. ASTM E3106-22


    Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

    • Most Recent
  2. ASTM E3106-18e1

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    Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

    • Historical Version
  3. ASTM E3106-18


    Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

    • Historical Version
  4. ASTM E3106-17


    Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation

    • Historical Version