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ASTM E2363

Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

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Organization: ASTM
Publication Date: 1 July 2004
Status: inactive
Page Count: 3
ICS Code (Health care technology (Vocabularies)): 01.040.11
ICS Code (Pharmaceutics in general): 11.120.01
scope:

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.

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.

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.

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

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.

Document History

December 1, 2014
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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...
July 15, 2006
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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...
January 15, 2006
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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...
October 15, 2005
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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...
August 15, 2005
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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...
March 1, 2005
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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...
December 1, 2004
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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...
ASTM E2363
July 1, 2004
Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
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...
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