ASTM E3077-17e2

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

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.
SCOPE
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.

General Information

• Status: Published
• Publication Date: 31-May-2017
• ICS: 35.240.63 - IT applications in trade
• Technical Committee: E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
• Drafting Committee: E55.13 - Process Evaluation and Control

Standards Content (Sample)

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.
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Designation: E3077 − 17
Standard Guide for
Raw Material eData Transfer from Material Suppliers to
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Pharmaceutical & Biopharmaceutical Manufacturers
This standard is issued under the fixed designation E3077; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1
ε NOTE—Editorial corrections were made to Table 1 in July 2017.
2
ε NOTE—Editorial corrections were made to Table 1 in September 2019.
1. Scope 2. Referenced Documents
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2.1 ASTM Standards:
1.1 This guide is applicable to all elements of raw material
E2363 Terminology Relating to Manufacturing of Pharma-
electronic data (eData) transfer from a Supplier which provides
ceutical and Biopharmaceutical Products in the Pharma-
a raw material to a Customer which receives the raw material.
ceutical and Biopharmaceutical Industry
1.2 This guide is developed for pharmaceutical and biophar-
E2500 Guide for Specification, Design, and Verification of
maceutical manufacturers and their suppliers, but may be
Pharmaceutical and Biopharmaceutical Manufacturing
suitable for other industries that routinely transfer data.
Systems and Equipment
1.3 The guide may also be applicable to raw material eData
E3051 Guide for Specification, Design, Verification, and
transfer between companies in the supply chain. Application of Single-Use Systems in Pharmaceutical and
Biopharmaceutical Manufacturing
1.4 The guide is applicable to new and existing raw mate-
2.2 Other Documents:
rials.
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Extensible Markup Language (XML) 1.0 (fifth edition)
1.5 This guide is applicable to the life-cycle of a raw
4
ISO 8601 Data Elements and Interchange Formats
material (that is, data generated throughout the processing
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XML Signature Syntax and Processing (second edition)
stages of the raw material) and is not dependent on the Supplier
or Customer.
3. Terminology
1.6 This guide describes two major areas of eData standard:
3.1 Definitions—For definitions of terms used in this guide,
the data format and the data content including the taxonomy
refer to Terminology E2363.
and nomenclature.
3.2 Definitions of Terms Specific to This Standard:
1.7 The guide currently only covers data content and data
3.2.1 certificate, n—a document that confirms a product
format in the English language. The data format shall not be
meets its specifications and is issued by the Supplier or third
translated. Use of other languages for the data content outside
party per individual lot and commonly contains actual testing
the scope of this guide.
results that are part of quality control of the product lot; the
certificates are sometimes called by other names such as:
1.8 The format is based on Extensible Markup Language
Certificate of Analysis (CoA), Certificate of Conformance
(XML) 1.0.
(CoC), Certificate of Quality, Certificate of Conformity, or
1.9 This international standard was developed in accor-
Declaration of Conformity.
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
mendations issued by the World Trade Organization Technical
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Barriers to Trade (TBT) Committee.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3
Available from World Wide Web Consortium (W3C), https://www.w3.org/TR/
REC-xml.
1 4
This guide is under the jurisdiction of ASTM Committee E55 on Manufacture Available from International Organization for Standardization (ISO), ISO
of Pharmaceutical and Biopharmaceutical Products and is the direct responsibility of Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
Subcommittee E55.13 on Process Evaluation and Control. Geneva, Switzerland, http://www.iso.org.
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Current edition approved June 1, 2017. Published June 1, 2017. DOI: 10.1520/ Available from World Wide Web Consortium (W3C), https://www.w3.org/TR/
E3077-17E02. xmldsig-core.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E3077 − 17
3.2.2 customer, n—the receiver of the raw material; the 6.2 Risk Management Approach:
content of the CoA (including specifications of the raw
6.2.1 The scope and extent of quality risk management for
materi
...