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Structured Product Labeling (SPL ) - An Overview

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    Structured Product Labeling (SPL ) - An Overview Structured Product Labeling (SPL ) - An Overview Presentation Transcript

    • Shakul Hameed Structured Product Labeling (SPL) An Overview
    • What is SPL?
      • The Structured Product Labeling (SPL) is a document markup standard developed by Health Level Seven (HL7)
      • Adopted by FDA as their mechanism for submitting and sharing product information.
      • SPL is a standard that is used by drug companies, FDA and public to exchange or review or view product information.
      • SPL is created using Extensible Markup Language (XML) Similar to HTML for WebPages
    • SPL - Language
      • SPL is a “language” that computers systems using the SPL standard can “understand”
      • SPL document is a message that is used to exchange product information (SPL content)
      • Drug company Creates SPL using SPL standard and Submits SPL to FDA
      • FDA Processes and validates SPL document using SPL standard
      • Transmits SPL to public repository (Daily Med)
    • Information Exchange in SPL SPL is a standard that is used by drug companies, FDA and public to exchange or review or view product information. All three entities use computer systems that “understand” SPL
    • Communication in Verbal – Different Language
    • Communication in Verbal – Identical Language
    • SPL’s Goal is to make the labeling: People friendly - Labeling content in electronic format Improve readability Better access Computer friendly - Medication information that is computer readable Structured labeling content and elements - Computer can “find” a specific section of the labeling and specific elements within labeling
    • SPL’s Goal is to make the labeling:
      • Information system friendly
      • Medication information in computer readable form - Easily imported into information systems
      • Publicly available
      • Content of Labeling (up-to-date version) is made available by the FDA through NLM (DailyMed) to consumers and health information suppliers
    • The SPL Document
      • An SPL document is comprised of a header and a body
      Header Body
    • Major components of an SPL document
    • The SPL Document
      • SPL Header identifies and classifies the document and may provide information such as company name, address, responsible persons and title of the document.
    • The SPL Document
      • The Body contains the product labeling content itself
      • Body Contains one or more sections
      • Sections contain the human readable content (called the narrative block)
    • The SPL Document
    • The Basic Structure of SPL
    • Creation and Validation of SPL Labeling content
      • SPL Labeling content created by using SPL software tools eg (Xforms its a free software recommend by FDA to create SPL).
      • After creation of SPL files FDA requested to the submitter to validate your SPL document before sending to the FDA by using Pragmatic Validator (Free Validator tool available online http://validator.pragmaticdata.com/validator-lite/ )
      • After Validating the submission company has to send their SPL document only through ESG to FDA.
    • SPL Labeling content
    • Why XML for SPL?
      • XML
      • – Relatively human-legible
      • – Machine readable
      • – Tags (elements) permit search of key information
      • XML Documents – created via Notepad, Word Pad, XML editing tools, SPL authoring tools, SPL conversion services, Xforms, etc…
      • XSL Style sheet – transforms the XML data to be viewed via web browser or printed documents
    • Transition from Paper to Electronic Registration & Listing
      • Changes in FD&C Act require electronic registration and listing for human prescription drugs, OTC, animal drug, biologic products – September 2007
      • Draft Guidance document for electronic drug establishment registration and listing – July 2008
      • FDA is adopting the use of extensible markup language (XML) files in SPL format as the standard format for the exchange of drug establishment registration and drug listing information.
    • Three e-Files for Registration & Listing - SPL Format
      • NDC Labeler Code Request
      • Establishment Registration
      • Content of labeling (CoL)/Listing
    • Order of Submissions for SPL
      • NDC Labeler Request (LCR) and Establishment Registration (ER) SPL
      • CoL/Listing SPL
      • CoL/Listing validates against data submitted in NDC LCR and ER SPL
    • NDC Labeler Request (LCR)
      • The National Drug Code (NDC) is a unique product identifier used in the United States for drugs intended for human use
      • The National Drug Code is a unique 10-digit, 3-segment numeric identifier.
      • For first time company has to request a new NDC Labeler Code for their product.
      • Once the NDC Labeler Code is assigned, They can update and resubmit their SPL file to FDA.
    • NDC Labeler Code Request Data
    • NDC Labeler Request (LCR) SPL Document
    • Drug Establishments Registration
      • Each Registrant (owner/operator firm) must submit one SPL file with registration information for all of its facilities (unlimited amount of domestic or foreign establishments per file)
      • Updates of information require re-submission of the same updated SPL file (at least annually)
      • Simplified SPL files are submitted for ‘No Change 'or ‘Out of Business 'notification
    • Establishment Registration Data
    • Establishment Registration SPL Document
    • “ ROAD MAP” FOR CREATING AND SUBMITTING SPLTO FDA
    • Benefits of Electronic Registration and Listing
      • Electronic registration and listing process is more efficient and effective for industry and the Agency
      • Accurate, up-to-date inventory of marketed drugs
      • Eliminates data entry errors
      • Well formed and properly created SPL files can be processed in minutes
      • Use existing technology and data standard – SPL (Used by FDA since 2005)
    • Benefits of Electronic Registration and Listing
      • Data maintenance
      • – Content of Labeling and listing information in one file.
      • – Registrant can list all it’s establishments in one file.
      • – Updates? Update one file instead of creating many paper forms and resubmit.
      • Eliminates the use of paper forms for listing and registration
      • 24-hour submission window
      • Manage data using same source (files) as FDA
      • Annual registration – send one file and automatically register all of your establishments