ASTM-E2363 2005

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E2363-05 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

Published By	Publication Date	Number of Pages
ASTM	2005	3

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Categories: 01.040.11 - Health care technology (Vocabularies), 11.120.01 - Pharmaceutics in general, ASTM

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Description

1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to process analytical technology may be more clearly stated.

1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.

1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.

1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.

1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.

Additional information

Standard Title	E2363-05 Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
Published Code	ASTM
Publication Date	2005
Pages Count	3
ICS Codes	01.040.11 - Health care technology (Vocabularies) 11.120.01 - Pharmaceutics in general

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ASTM-E2363 2005

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