Name: ASTM E 3077 : 2017 : EDT 2
Brand: ASTM
Price: 103.13 AUD

Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-08-2023

Publisher

American Society for Testing and Materials

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.

1.1This 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.

Committee	E 55
DocumentType	Guide
Pages	6
ProductNote	Editorial corrections were made to Table 1 in September 2019.
PublisherName	American Society for Testing and Materials
Status	Current
Supersedes	ASTM E 3077 : 2017 : EDT 1

ASTM E 3326 : 2022

Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry

ASTM E 2363 : 2023	Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry
ASTM E 2500 : 2020	Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ASTM E 2363 : 2014	Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry
ASTM E 3051 : 2016	Standard Guide for Specification, Design, Verification, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing

View more information

$103.13

Including GST where applicable

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

Get in touch with us

ASTM E 3077 : 2017 : EDT 2

Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers

Abstract

Scope

General Product Information

Standards Referenced By This Book

Standards Referencing This Book

Category

Subcategory