ASTM E2363 - 14 - Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

ASTM E2363 - 14

Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

Status : Current   Published : January 2014

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PDF

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HARDCOPY



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 eferences 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.

1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.




Standard NumberASTM E2363 - 14
TitleStandard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
StatusCurrent
Publication Date12 January 2014
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors Pharmaceutical Engineering, Pharmaceutical Industry, Process Analytical Technology
ICS01.040.11
PublisherASTM
FormatA4
DeliveryYes
Pages10
File Size127 KB
Price£40.00


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