ASTM E3106 - 18e1

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

    Active Standard ASTM E3106 | Developed by Subcommittee: E55.03

    Book of Standards Volume: 14.05


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    Significance and Use

    4.1 Application of the approach described within this guide applies risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality and documentation for cleaning should also be commensurate with the level of risk.

    4.2 Application of the approach described within this guide applies many of the science-based, risk-based, and statistical concepts and principles introduced in the FDA’s Guidance for Industry Process Validation: General Principles and Practices (3).

    4.3 This guide supports, and is consistent with, elements from ICH Q8, ICH Q9, ICH Q10, and ICH Q11.

    4.4 Key Concepts—This guide applies the following key concepts: (1) quality risk management, (2) science-based approach, (3) statistics-based approach, (4) process understanding, and (5) continued improvement as described in the ICH Q series.

    1. Scope

    1.1 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.

    1.2 This guide is focused only on the cleaning of equipment product contact surfaces and does not cover disinfection or non-product contact surfaces (which are covered under other existing guides: Ref (1),2 USP <1072>, Guide E2614, and ISO 14698).

    1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

    1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ICH Standards

    Q8

    Q9 Quality Risk Management

    Q11 Development and Manufacture of Drug Substances

    ASTM Standards

    E1325 Terminology Relating to Design of Experiments

    E2476 Guide for Risk Assessment and Risk Control as it Impacts the Design, Development, and Operation of PAT Processes for Pharmaceutical Manufacture

    E2614 Guide for Evaluation of Cleanroom Disinfectants


    ICS Code

    ICS Number Code 13.020.60 (Product life-cycles)

    UNSPSC Code

    UNSPSC Code


    Referencing This Standard
    Link Here
    Link to Active (This link will always route to the current Active version of the standard.)

    DOI: 10.1520/E3106-18E01

    Citation Format

    ASTM E3106-18e1, Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation, ASTM International, West Conshohocken, PA, 2018, www.astm.org

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