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ASTM E2363-05

Historical Revision

Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry

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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.


SDO ASTM: ASTM International
Document Number E2363
Publication Date March 1, 2005
Language en - English
Page Count 3
Revision Level 05
Supercedes
Committee E55.91
Publish Date Document Id Type View
Jan. 1, 2023 E2363-23 Revision
Dec. 1, 2014 E2363-14 Revision
July 15, 2006 E2363-06A Revision
Jan. 15, 2006 E2363-06 Revision
Oct. 15, 2005 E2363-05B Revision
Aug. 15, 2005 E2363-05A Revision
March 1, 2005 E2363-05 Revision
Dec. 1, 2004 E2363-04A Revision
July 1, 2004 E2363-04 Revision