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ASTM E3077-17

(Guide)

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

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
Historical
Publication Date
31-May-2017
ICS
35.240.63 - IT applications in trade
Technical Committee
E55 - Manufacture of Pharmaceutical and Biopharmaceutical Products
Drafting Committee
E55.03 - General Pharmaceutical Standards
Current Stage
Ref Project

Relations

Replaced By
ASTM E3077-17e1 - Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
Effective Date
01-Jun-2017
Referred By
ASTM E3326-22 - Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry
Effective Date
01-Jun-2017

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ASTM E3077-17 - Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical ManufacturersASTM E3077-17 - Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
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ASTM E3077-17 - Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E3077 − 17
Standard Guide for
Raw Material eData Transfer from Material Suppliers to
1
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. Scope 2. Referenced Documents
2
1.1 This guide is applicable to all elements of raw material 2.1 ASTM Standards:
electronic data (eData) transfer from a Supplier which provides E2363 Terminology Relating to ProcessAnalytical Technol-
a raw material to a Customer which receives the raw material. ogy in the Pharmaceutical Industry
E2500 Guide for Specification, Design, and Verification of
1.2 This guide is developed for pharmaceutical and biop-
Pharmaceutical and Biopharmaceutical Manufacturing
harmaceutical manufacturers and their suppliers, but may be
Systems and Equipment
suitable for other industries that routinely transfer data.
E3051 Guide for Specification, Design, Verification, and
1.3 The guide may also be applicable to raw material eData
Application of Single-Use Systems in Pharmaceutical and
transfer between companies in the supply chain.
Biopharmaceutical Manufacturing
1.4 The guide is applicable to new and existing raw mate- 2.2 Other Documents:
3
rials. Extensible Markup Language (XML) 1.0 (fifth edition)
4
ISO 8601 Data Elements and Interchange Formats
1.5 This guide is applicable to the life-cycle of a raw
5
XML Signature Syntax and Processing (second edition)
material (that is, data generated throughout the processing
stagesoftherawmaterial)andisnotdependentontheSupplier
3. Terminology
or Customer.
3.1 Definitions—For definitions of terms used in this guide,
1.6 This guide describes two major areas of eData standard:
refer to Terminology E2363.
the data format and the data content including the taxonomy
3.2 Definitions of Terms Specific to This Standard:
and nomenclature.
3.2.1 certificate, n—a document that confirms a product
1.7 The guide currently only covers data content and data
meets its specifications and is issued by the Supplier or third
format in the English language. The data format shall not be
party per individual lot and commonly contains actual testing
translated. Use of other languages for the data content outside
results that are part of quality control of the product lot; the
the scope of this guide.
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
Declaration of Conformity.
1.9 This international standard was developed in accor-
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Development of International Standards, Guides and Recom-
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
mendations issued by the World Trade Organization Technical
the ASTM website.
Barriers to Trade (TBT) Committee.
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
ofPharmaceuticalandBiopharmaceuticalProductsandisthedirectresponsibilityof Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
Subcommittee E55.03 on General Pharmaceutical Standards. Geneva, Switzerland, http://www.iso.org.
5
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/
E3077-17. xmldsig-core.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
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
material) is based on agreement between the Customer and the
data transfer activities and documentation are based on the risk
Supplier.
to product quality and patient safety. Variation in raw materials
3.2.3 eData, n—electronic data is generated by the Supplier
is a concern and in order to understand the variability, the first
and received by the Customer which includes data found
ste
...

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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.  
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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.  
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