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  • ASTM
    E2475-10 Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control
    Edition: 2010
    $103.58
    Unlimited Users per year

Description of ASTM-E2475 2010

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




ASTM E2475

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

Keywords

control; pharmaceutical manufacture; process understanding;


ICS Code

ICS Number Code 11.120.01 (Pharmaceutics in general)


DOI: 10.1520/E2475-10

ASTM International is a member of CrossRef.

ASTM E2475

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About ASTM

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide.
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