ASTM E 3077 : 2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
Hardcopy , PDF
26-10-2017
English
01-06-2017
Important note : Users cannot be edited or removed once added to your Multi user PDF.CONTAINED IN VOL. 14.05, 2017 Pertains to all elements of raw material electronic data (eData) transfer from a Supplier which provides a raw material to a Customer which receives the raw material.
| Committee |
E 55
|
| DocumentType |
Guide
|
| Pages |
6
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
1.1This guide is applicable to all elements of raw material electronic data (eData) transfer from a Supplier which provides a raw material to a Customer which receives the raw material.
1.2This guide is developed for pharmaceutical and biopharmaceutical manufacturers and their suppliers, but may be suitable for other industries that routinely transfer data.
1.3The guide may also be applicable to raw material eData transfer between companies in the supply chain.
1.4The guide is applicable to new and existing raw materials.
1.5This guide is applicable to the life-cycle of a raw material (that is, data generated throughout the processing stages of the raw material) and is not dependent on the Supplier or Customer.
1.6This guide describes two major areas of eData standard: the data format and the data content including the taxonomy and nomenclature.
1.7The guide currently only covers data content and data format in the English language. The data format shall not be translated. Use of other languages for the data content outside the scope of this guide.
1.8The format is based on Extensible Markup Language (XML) 1.0.
1.9This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
| ASTM E 2363 : 2014 : REDLINE | Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry |
| ASTM E 2500 : 2013 : REDLINE | Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| CFR 21(PTS1-99) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99 |
| ASTM E 3051 : 2016 | Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing |
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