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ASTM E3077-17
Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
6 стр.
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Разработчик:
Зарубежные/ASTM
Сборник (ASTM):
14.05 Statistical Methods; Hazard Potential of Chemicals; Thermal Measurements; Manufacture of Pharmaceutical and Biopharmaceutical Products / Статистические методы; Потенциальная опасность химических веществ; Измерения теплопроводности; Производство фармацевтических изделий
Тематика:
Pharmaceutical Applications
Описание
Значение и использование

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.

Область применения

1.1 Thisguide is applicable to all elements of raw material electronic data(eData) transfer from a Supplier which provides a raw material to aCustomer which receives the raw material.

1.2 Thisguide is developed for pharmaceutical and biopharmaceuticalmanufacturers and their suppliers, but may be suitable for otherindustries that routinely transfer data.

1.3 Theguide may also be applicable to raw material eData transfer betweencompanies in the supply chain.

1.4 Theguide is applicable to new and existing raw materials.

1.5 Thisguide is applicable to the life-cycle of a raw material (that is,data generated throughout the processing stages of the rawmaterial) and is not dependent on the Supplier or Customer.

1.6 Thisguide describes two major areas of eData standard: the data formatand the data content including the taxonomy and nomenclature.

1.7 Theguide currently only covers data content and data format in theEnglish language. The data format shall not be translated. Use ofother languages for the data content outside the scope of thisguide.

1.8 Theformat is based on Extensible Markup Language (XML) 1.0.

1.9This international standard was developed in accordance withinternationally recognized principles on standardizationestablished in the Decision on Principles for the Development ofInternational Standards, Guides and Recommendations issued by theWorld Trade Organization Technical Barriers to Trade (TBT)Committee.