ASTM WK15778

    New Guide for Science-based and Risk-based Cleaning Process Development and Validation

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


    1. Scope

    This Guide will provide a framework for science and risk based approaches to developing and validating Cleaning Processes for pharmaceutical products, biological products and APIs. This document addresses how risk characterization and risk assessment can be used to develop cleaning validation limits. This Guide will provide a scientific and risk based approach to developing cleaning processes for pharmaceutical and biological products; both Active Pharmaceutical Ingredients (APIs) and finished products. This Guide will provide a scientific and risk based approach to the planning of Cleaning Validations Programs. This includes the derivation of Product Safety Thresholds, the selection of equipment to test, products to test, and the sampling strategy. This section also provides for approaches for new product introduction and possible monitoring. This Guide will provide a statistically based process whereby the adequacy of Cleaning Processes can be demonstrated. This Guide will provide guidance on how to implement PAT for cleaning processes (e.g. CIP systems) and cleaning validation. Important secondary objectives of the guide are to ensure consistency and compliance with global regulations and guidance, particularly ICH Q8 and Q9; and to clearly define terms and their application to ensure a consistent and scientifically defensible process.

    This Guide is intended to be used by industry (Pharmaceutical, Biologics and API manufacturers) for the development of cleaning processes and the planning and validation of cleaning processes for equipment/systems that are regulated globally by such Agencies as the FDA, EMEA and MHLW. The guideline is currently being developed with the FDA as a ISPE Guideline and it has been recommended to migrate the ISPE guide to ASTM to become a global consensus standard.


    Science-based; Risk-based; Cleaning Development; Cleaning Validation; Acceptance Limits; PAT; CIP;

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:

    Technical Contact:
    Andrew Walsh


    E55.03 (16-02)

    Negative Votes Need Resolution