ASTM E 3077:2025

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 and is provided as an XML schema definition (XSD) file. 1.9 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.10 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.

35.240.63