ASTM E3077-2017e1 Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical &amp Biopharmaceutical Manufacturers《材料供应商向制药和生物制造制造商传送原材料电子数据的标准指南》.pdf

1、Designation: E3077 171Standard Guide forRaw Material eData Transfer from Material Suppliers toPharmaceutical the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of l

2、ast reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1NOTEEditorial corrections were made to Table 1 in July 2017.1. Scope1.1 This guide is applicable to all elements of raw materialelectronic data (eData) transfer from a Supplier which provides

3、a raw material to a Customer which receives the raw material.1.2 This guide is developed for pharmaceutical and biop-harmaceutical manufacturers and their suppliers, but may besuitable for other industries that routinely transfer data.1.3 The guide may also be applicable to raw material eDatatransfe

4、r between companies in the supply chain.1.4 The guide is applicable to new and existing raw mate-rials.1.5 This guide is applicable to the life-cycle of a rawmaterial (that is, data generated throughout the processingstages of the raw material) and is not dependent on the Supplieror Customer.1.6 Thi

5、s guide describes two major areas of eData standard:the data format and the data content including the taxonomyand nomenclature.1.7 The guide currently only covers data content and dataformat in the English language. The data format shall not betranslated. Use of other languages for the data content

6、 outsidethe 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 accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Sta

7、ndards, Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standards:2E2363 Terminology Relating to Process Analytical Technol-ogy in the Pharmaceutical IndustryE2500 Guide for Specification, Design, and Verif

8、ication ofPharmaceutical and Biopharmaceutical ManufacturingSystems and EquipmentE3051 Guide for Specification, Design, Verification, andApplication of Single-Use Systems in Pharmaceutical andBiopharmaceutical Manufacturing2.2 Other Documents:Extensible Markup Language (XML) 1.0 (fifth edition)3ISO

9、8601 Data Elements and Interchange Formats4XML Signature Syntax and Processing (second edition)53. Terminology3.1 DefinitionsFor definitions of terms used in this guide,refer to Terminology E2363.3.2 Definitions of Terms Specific to This Standard:3.2.1 certificate, na document that confirms a produc

10、tmeets its specifications and is issued by the Supplier or thirdparty per individual lot and commonly contains actual testingresults that are part of quality control of the product lot; thecertificates are sometimes called by other names such as:Certificate of Analysis (CoA), Certificate of Conforma

11、nce(CoC), Certificate of Quality, Certificate of Conformity, orDeclaration of Conformity.1This guide is under the jurisdiction of ASTM Committee E55 on Manufactureof Pharmaceutical and Biopharmaceutical Products and is the direct responsibility ofSubcommittee E55.03 on General Pharmaceutical Standar

12、ds.Current edition approved June 1, 2017. Published June 1, 2017. DOI: 10.1520/E3077-17E01.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Su

13、mmary page onthe ASTM website.3Available from World Wide Web Consortium (W3C), https:/www.w3.org/TR/REC-xml.4Available from International Organization for Standardization (ISO), ISOCentral Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,Geneva, Switzerland, http:/www.iso.org.5Avai

14、lable from World Wide Web Consortium (W3C), https:/www.w3.org/TR/xmldsig-core.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standar

15、dization established in the Decision on Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.2.2 customer, nthe receiver of the raw material; thecontent of the CoA (including specifi

16、cations of the rawmaterial) is based on agreement between the Customer and theSupplier.3.2.3 eData, nelectronic data is generated by the Supplierand received by the Customer which includes data foundwithin the CoA and any additional data agreed upon by theSupplier and the Customer for transfer.3.2.4

17、 raw material, nin the Biopharmaceutical industry,raw material includes all consumables in manufacturing of adrug product or drug substance such as media, buffers,disposable, bioreactor additives, process titrants, resin, filters,excipients, and primary containers, for instance, syringes,vials, capp

18、ers, and stoppers.3.2.5 supplier, nmanufactur or distributor of the rawmaterial that is required to generate a Certificate of Quality,such as CoA, CoC and deliver the raw material to its Customer.4. Summary of Guide4.1 This guide describes a data format that can be adoptedby Suppliers and Customers

19、to transfer raw material data in astandardized and scalable way.4.2 This guide also describes critical data content thatshould be included and offers recommendations for optionalbut informative data parameters that Suppliers and Customersmay want to adopt for mutual benefit.5. Significance and Use5.

20、1 Application of the approach described within this guideis intended to achieve a biopharma industry-wide standardformat that will be available for electronic data transferbetween Supplier and Customer for monitoring and studyingvariability.5.2 This guide supports and facilitates fast data transfer,

21、thereby avoiding data recapture, human interaction, and tran-scription errors; and thus enables a more streamlined businessprocess.5.3 If the eData structure does not conform to the XSDdefined by this guide then it is not guaranteed to be inter-operable. Feedback or change requests should be directe

22、d toASTM Headquarters, to the attention of the Committee E55Staff Manager.5.4 Digital Signature can be adopted and used as part of theeData transfer. XML and XSD are provided in two formats:with and without digital signature configuration. User canfollow either format for implmenation to ensure conf

23、ormingwith the ASTM eData XSD structure.6. Key Concepts6.1 This guide applies the following key concepts:6.1.1 Risk management approach,6.1.2 Use of Supplier documentation, and6.1.3 Data transfer methods.6.2 Risk Management Approach:6.2.1 The scope and extent of quality risk management fordata trans

24、fer activities and documentation are based on the riskto product quality and patient safety. Variation in raw materialsis a concern and in order to understand the variability, the firststep is to have an efficient way of obtaining the data. Having astandardized eData format for both the Suppliers an

25、d Custom-ers is the first step in achieving this goal.6.2.2 Having a standard way to generate and consume datawill avoid multiple formats that one Supplier has to generate tosuit various Customer requirements. In addition, using eDatastandard format as a template, the Suppliers data sourcesystem bui

26、lt will allow simpler compilation of data on anongoing basis. This will reduce cost and resources for imple-menting eData transfer between Supplier and Customers.6.2.3 Following the format described in this guide, changemanagement can be provided in a dependable mechanism fortracking and prompt impl

27、ementation of technically soundimprovements.6.3 Use of Supplier Documentation:6.3.1 Supplier documentation should be used provided thatthe regulated company has assessed the Supplier, and hasevidence that the Supplier has: an acceptable supplier qualitysystem, technical capability, and demonstrated

28、application ofgood engineering practice (GEP) such that information ob-tained from the supplier will be accurate. Details on Supplierdocumentation can be found in Guides E2500 and E3051.6.4 Data Transfer Methods:6.4.1 It is critical that the data transferred from Supplier toCustomer are intact durin

29、g the transfer. Since computer sys-tems and networks are vulnerable to data loss and unauthorizedmanipulation, it is important that the Customer has somemeans of verifying the integrity of the data. Suppliers andCustomers should agree on methods to ensure that the trans-ferred data is not modified a

30、ccidentally or intentionally. Thisguide describes an optional digital signature (including check-sum) capability to ensure the integrity of the transferred data.Data encryption is not addressed in the scope of this guide.Additional means such as Secure File Transfer Protocol (SFTP)or Internet Protoc

31、ol Security (IPsec) may be employed toprovide additional security for the transfer of eData documentsvia internet.6.5 Detect Data Transfer ErrorIf digital signature is notimplemented, in order to ensure data integrity and to detecterror that may have been introduced during transmission andstorage, i

32、t is recommended that Checksum should be imple-mented to the data files transferred between Suppliers and theend users.6.6 Utilizing XSD Schema to Generate XMLThird-partysolutions on the market can be used to generate XML based onthe XSD schema provided in this guide.E3077 17126.7 Suppliers may reas

33、onably request that Customers keepinformation confidential to avoid disclosure of sensitive infor-mation to other parties. If necessary, critical information can beblinded using linear filters whereby the actual name of aparameter can be blinded and the actual measurement valuesare subjected to a li

34、near transform so that Supplier proprietaryinformation is concealed while still allowing Customers tocorrelate variability to process performance. Any data that iscoded needs to be consistently coded over time to ensure thatthe tracking objectives are met. If coding changes, suchchanges need to be c

35、aptured in a traceable form.7. Data Transfer Content7.1 Table 1 describes the data transfer content and theirbasic layout. The table is divided into Required fields and somesuggested Optional fields. To the right of each field is a briefexplanation of the meaning of the content. Details of the exact

36、content will be determined by the Supplier and end user. Thistable is a reference guide; a formal specification of the dataformat is provided as an XML Schema Definition (XSD) file.8. Keywords8.1 eData transfer; material; suppliersE3077 1713TABLE1DataTransferContentXMLElementNameTypeofTagReqdOccurre

37、ncesFieldTypeDescriptionXMLDeclarationYes1DeclarethisisaXMLfile(hardcode).SectionStartYes1Thedefaultnamespacehttps:/staging.astm.org/e55edataxchange.htmlisspecifictothisguideandpreventscollisionswithelementnamesinothernamespaces.SectionStartYes1ContainsinformationontheXMLfile,oneperXMLfile.Theversio

38、nattributeshallbesetto1.0(forexample,version=“1.0”)toindicatetheversionofthisguidetowhichtheeDatadocumentconforms.FieldNoNumericTotrackchangesatendusersystems.EnduserwillprovidetheversionnumbertoSuppliertopopulate.ThisfieldwillremainthesameuntiltheendusercommunicatesanupdatetotheSupplier.Versionofth

39、isfielddoesnotaffecttheFileInformationortheContentRevisionversions.FieldNoAlphae-mailaddressforquestionsrelatedtothefileinformationandformatoftheXMLdocument.FieldNoAlphae-mailaddressforquestionsrelatedtotheeDatacontent.FieldYesYYYY-MM-DDDatewhentheXMLfilewasgeneratedinaccordancewithISO8601extendedfo

40、rmat.FieldYesHH:MM:SSZTimewhentheXMLfilewasgenerated(UTC)inaccordancewithISO8601extendedformat.FieldYesNumericUsedtotracktheinformationcontentrevisionasagreedinacontractbetweenaspecificSupplierandanenduser.SectionStartNoThisfieldisanoptionalenvelopeddigitalsignature.Ifadigitalsignatureisprovided,itm

41、ustconformtoXMLSignatureSyntaxandProcessing,inparticulartheschemaxmlsig-core-schema.xsd.Inordertoensurebroadinteroperability,SuppliersmustuseeithertheDSAwithSHA1algorithmortheHMAC-SHA1algorithm.SignersmustapplytheEnvelopedSignaturetransformandeitherCanonicalXML1.0(omitscomments)transformorCanonicalX

42、ML1.1(omitscomments)transformtotheeDatadocumentpriortocomputingthesignature.ThisguidedoesnotindicatehowSuppliersshouldtransmitames-sageauthenticationcode(MAClikeapassword,forHMAC-SHA1)orapublickey(forDSA)toCus-tomers.SuppliersusingtheDSAalgorithmmustincludeKeyInfoelementwithatleasttheDSAKey-Valueele

43、mentspecifiedtofacilitateverificationbyCustomers.Onlyonesignatureispermitted.Customersshallacceptanydigitalsignatureconformingtotheaboverequirements.SectionEndNoEndTag.SectionEndYesEndTag.SectionStartYes1Sectionofmaterialinformationanddataresults.FieldYesAlphaForSupplierstoentercomments.SectionStart

44、YesMayoccurmultipletimeswithinthesection.Eachcertificatecontainsresultsforonematerial.EachMaterialDataGrouphasa“MaterialDataLotID”attribute,whichisreferencedbytheMaterialDatatokeeptheintegrityofthefileusingAttribute:name=“MaterialDataLotRef”.type=“IDREF”Attribute:name=“MaterialDataLotID”type=“ID”.Ea

45、chMaterialDatahasanattributethatreferencestheMaterialDataLotIDforthisMaterialData.FieldNoAlphaToincludenameoftheQualitysignoff.FieldYesAlphaNameofthemanufacturerofthismaterial/sometimesforS-1supplier,canbedistributornameifthemanufacturernameisnotavailable.Attribute:name=“Type”type=“string”.Values=Di

46、stributor,Manufacturer;default=“Manufacturer”;ThisDistributorversusManufacturerattributeisrequired.Attribute:name=“Level”type=“int”.ManufacturingLevelrelativetoeDatareceiving(thatis,directsupplier=0,supplierscomponentsupplier=1),defaulttodirectsupplier.ThisAttributeisrequired.Level0dataisrequiredfor

47、everydatafile.Attribute:name=“Plant”type=“string”.Plantcodeornamewherethismaterialwasmanufactured.Thisattributeisoptional.FieldYesAlphaProductName.FieldYesAlphaProductPart/MaterialNumber.FieldYesAlphaLotnumberAttribute:name=“LotDate”type=”“date”format=“YYYY-MM-DD”.Thisattributeisrequired.Attribute:n

48、ame=“ManufactureReceive”type=“string”Values=“MfgDate”,“ReceiveDate”default=“MfgDate”;Thisattributereferstolotreceiveddateorlotmanufacturedate.Thisattributeisoptional.Attribute:name=“ExpDate”type=“date”format=“YYYY-MM-DD”.Supplierslotexpirationdate.Thisattri-buteisoptional.FieldNoNumericQuantityofthe

49、lotinnumericformat.FieldNoAlphaUnitofmeasureforthequantity.SectionStartNo11occurrenceper,containsmaterialdataresults.SectionStartNo*Mayoccurmultipletimeswithinthesection.FieldYesAlphaShorttest/assaydescriptionname.E3077 1714TABLE1ContinuedXMLElementNameTypeofTagReqdOccurrencesFieldTypeDescriptionFieldNoAlphaLongtest/assaydescriptionname.FieldNoAlphaTestorAttributeofamaterialorcomponent(forexample,pH,purity,outsidediameter).Note:Maybesimilar/sameasShortName.FieldNoAlphaVariableusedtodifferentiatemultiplevariablesmeasuredonthesameattribute(forexample,minimu