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Significance and Use
5.1 Application of the approach described within this guide is intended to achieve a biopharma industry-wide standard format that will be available for electronic data transfer between Supplier and Customer for monitoring and studying variability.
5.2 This guide supports and facilitates fast data transfer, thereby avoiding data recapture, human interaction, and transcription errors; and thus enables a more streamlined business process.
5.3 If the eData structure does not conform to the XSD defined by this guide then it is not guaranteed to be inter-operable. Feedback or change requests should be directed to ASTM Headquarters, to the attention of the Committee E55 Staff Manager.
5.4 Digital Signature can be adopted and used as part of the eData transfer. XML and XSD are provided in two formats: with and without digital signature configuration. User can follow either format for implmenation to ensure conforming with the ASTM eData XSD structure.
1.1 This 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.
1.2 This guide is developed for pharmaceutical and biopharmaceutical manufacturers and their suppliers, but may be suitable for other industries that routinely transfer data.
1.3 The guide may also be applicable to raw material eData transfer between companies in the supply chain.
1.4 The guide is applicable to new and existing raw materials.
1.5 This 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.
1.6 This guide describes two major areas of eData standard: the data format and the data content including the taxonomy and nomenclature.
1.7 The 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.
1.8 The format is based on Extensible Markup Language (XML) 1.0.
1.9 This 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.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Other DocumentsExtensible Markup Language (XML) 1.0 (fifth edition) Available from World Wide Web Consortium (W3C), https://www.w3.org/TR/REC-xml. XML Signature Syntax and Processing (second edition) Available from World Wide Web Consortium (W3C), https://www.w3.org/TR/xmldsig-core.
E2363 Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
E2500 Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ICS Number Code 35.240.63 (IT applications in trade)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM E3077-17e2, Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers, ASTM International, West Conshohocken, PA, 2017, www.astm.orgBack to Top