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Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers
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.
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.
Keywords
eData transfer; material; suppliers Data Transfer Content XML Element Name Type of Tag Req’d Occurrences Field Type Description
<?xml version=“1.0” encoding=“UTF-8” standalone=“yes” ?> XML Declaration Yes 1 Declare this is a XML file (hardcode).
<ASTMeDataXchange xmlns=“http://astm.org/E55/03/eDataXchange”> Section Start Yes 1 The default namespace http://www.astm.org/E55/03/eDataXchange is specific to this guide and prevents collisions with element names in other namespaces.
<FileInformation> Section Start Yes 1 Contains information on the XML file, one per XML file. The version attribute shall be set to 1.0 (for example, version=“1.0”) to indicate the version of this guide to which the eData document conforms.
<EndUserSystemVersion /> Field No Numeric To track changes at end user systems. End user will provide the version number to Supplier to populate. This field will remain the same until the end user communicates an update to the Supplier. Version of this field does not affect the FileInformation or the ContentRevision versions.
<FilePartyEmail /> Field No Alpha e-mail address for questions related to the file information and format of the XML document.
<DataPartyEmail /> Field No Alpha e-mail address for questions related to the eData content.
<GenerationDate /> Field Yes YYYY-MM-DD Date when the XML file was generated in accordance with ISO 8601 extended format.
<GenerationTime /> Field Yes HH:MM:SSZ Time when the XML file was generated (UTC) in accordance with ISO 8601 extended format.
<ContentRevision /> Field Yes Numeric Used to track the information content revision as agreed in a contract between a specific Supplier and an end user.
<Signature> Section Start No This field is an optional enveloped digital signature. If a digital signature is provided, it must conform to XML Signature Syntax and Processing, in particular the schema xmlsig-core-schema.xsd. In order to ensure broad interoperability, Suppliers must use either the DSA with SHA1 algorithm or the HMAC-SHA1 algorithm. Signers must apply the Enveloped Signature transform and either Canonical XML 1.0 (omits comments) transform or Canonical XML 1.1 (omits comments) transform to the eData document prior to computing the signature. This guide does not indicate how Suppliers should transmit a message authentication code (MAC—like a password, for HMAC-SHA1) or a public key (for DSA) to Customers. Suppliers using the DSA algorithm must include KeyInfo element with at least the DSAKeyValue element specified to facilitate verification by Customers. Only one signature is permitted. Customers shall accept any digital signature conforming to the above requirements.
</Signature> Section End No End Tag.
</FileInformation> Section End Yes End Tag.
<MaterialDataGroup> Section Start Yes 1 Section of material information and data results.
<Comments /> Field Yes Alpha For Suppliers to enter comments.
<MaterialData> Section Start Yes May occur multiple times within the <MaterialDataGroup> section. Each certificate contains results for one material.
Each MaterialDataGroup has a “MaterialDataLotID” attribute, which is referenced by the MaterialData to keep the integrity of the file using Attribute: name=“MaterialDataLotRef”. type=“IDREF”
Attribute: name=“MaterialDataLotID” type=“ID”. Each MaterialData has an attribute that references the MaterialDataLotID for this MaterialData.
<QualitySignature /> Field No Alpha To include name of the Quality sign off.
<Manufacturer /> Field Yes Alpha Name of the manufacturer of this material/sometimes for S-1 supplier, can be distributor name if the manufacturer name is not available.
Attribute: name=“Type” type=“string”. Values = Distributor, Manufacturer; default = “Manufacturer”; This Distributor versus Manufacturer attribute is required.
Attribute: name=“Level” type=“int”. Manufacturing Level relative to eData receiving (that is, direct supplier = 0, supplier's component supplier = 1), default to direct supplier. This Attribute is required. Level 0 data is required for every data file.
Attribute: name=“Plant” type=“string”. Plant code or name where this material was manufactured. This attribute is optional.
<ProductName /> Field Yes Alpha Product Name.
<PartNumber /> Field Yes Alpha Product Part/Material Number.
<Lot /> Field Yes Alpha Lot number Attribute: name=“LotDate” type=”“date” format=“YYYY-MM-DD”. This attribute is required.
Attribute: name=“ManufactureReceive” type=“string” Values = “MfgDate”, “ReceiveDate” default=“MfgDate” ; This attribute refers to lot received date or lot manufacture date. This attribute is optional.
Attribute: name=“ExpDate” type=“date” format=“YYYY-MM-DD”. Supplier’s lot expiration date. This attribute is optional.
<Quantity /> Field No Numeric Quantity of the lot in numeric format.
<QuantityUOM /> Field No Alpha Unit of measure for the quantity.
<MaterialParameters> Section Start No 1 1 occurrence per <MaterialData>, contains material data results.
<MaterialParameter> Section Start No * May occur multiple times within the <MaterialData> section.
<Name /> Field Yes Alpha Short test/assay description name.
<Description /> Field No Alpha Long test/assay description name.
<MeasurementAttribute /> Field No Alpha Test or Attribute of a material or component (for example, pH, purity, outside diameter). Note: May be similar/same as Short Name.
<MeasurementVariable /> Field No Alpha Variable used to differentiate multiple variables measured on the same attribute (for example, minimum, maximum, mean).
<UnitOfMeasure /> Field No Alpha Unit of measure.
<Method /> Field No Alpha Measurement method used by the supplier.
<MeasurementType /> Field No Alpha Measurement type (EQ/LT/LTE/GT/GTE). Used in conjunction with the MeasurementValue field
<MeasurementValue /> Field No Numeric Measurement numeric value (numeric values are only accepted).
<MeasurementText /> Field No Alpha Measured value with symbols as it appears on the CoA or data result, since the “<” symbol may be used in this field Character Data (CDATA) may appear.
<MeasurementTestLot /> Field No Alpha Identifier for test execution lot, to track information regarding different test lots.
<SpecificationNumber /> Field No Alpha Specification number related to the material at the end user if available.
<Specification /> Field No Alpha Specifications as it appears on the CoA (that is, Range or “>” or “<” symbols); if symbol is used in this field CDATA may appear.
<SampleLocation /> Field No Alpha If more than one measurement of the same type occurs, this field can be used to specify where in the process the measurement occurred.
</MaterialParameter> Section End Yes End Tag.
</MaterialParameters> Section End Yes End Tag.
</MaterialData> Section End Yes End Tag.
</MaterialDataGroup> Section End Yes End Tag.
</ASTMeDataXchange> Section End Yes End Tag.
;; ICS Number Code 35.240.63 (IT applications in trade)
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