ASTM E2475 - 10

    Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

    Active Standard ASTM E2475 | Developed by Subcommittee: E55.01

    Book of Standards Volume: 14.02


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    1. Scope

    1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using quality by design (QbD) (Juran, 1992; FDA/ICH Q8). The framework is applicable to both active pharmaceutical ingredient (API) and to drug product (DP) manufacturing. High (detailed) level process understanding can be used to facilitate production of product which consistently meets required specifications. It can also play a key role in continuous process improvement efforts.

    1.2 Process Analytical Technology (PAT) is one element that can be used for achieving control over those inputs determined to be critical to a process. It is important for the reader to recognize that PAT is defined as:


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

    ASTM Standards

    E456 Terminology Relating to Quality and Statistics

    E2281 Practice for Process and Measurement Capability Indices

    E2474 Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology

    E2617 Practice for Validation of Empirically Derived Multivariate Calibrations

    U.S. Government Publications

    U.S.FDAPAT Guidance Document, Guidance for Industry PATA Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance


    ICS Code

    ICS Number Code 11.120.01 (Pharmaceutics in general)

    UNSPSC Code

    UNSPSC Code 85121902(Commercial pharmaceutical services)


    DOI: 10.1520/E2475-10

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