542 - Destruction

Russia Compliance Owners generate the 542 - Destruction report to capture information about serialized items that are disposed of in a destruction facility (i.e. the items are decommissioned or destroyed in TraceLink).

Configuring the report

  1. Hover over Company Administration on the User Profile drop-down in the top right of any screen, and then select Workflow.
  2. To configure the event workflow for decommissioning events:
    • Select the Generate 542 - Destruction Report Resulting Actions checkbox for the Product Decommissioned workflow Event.

      or

      Select the Generate 542 - Destruction Report Resulting Actions checkbox for the ESM Product Decommissioned workflow Event (required if sending and receiving ESM integration messages).

  3. To configure the event workflow for destruction events:
    • Select the Generate 542 - Destruction Report Resulting Actions checkbox for the Product Destroyed workflow Event.

      or

      Select the Generate 542 - Destruction Report Resulting Actions checkbox for the ESM Product Destroyed workflow Event (required if sending and receiving ESM integration messages).

  4. Select Save in the top left of the screen, above the results table.

    The screen refreshes, and the workflow is enabled.

The Russia Compliance application generates the 542 - Destruction report when TraceLink processes a Product Decommissioned, ESM Product Decommissioned, Product Destroyed, or ESM Product Destroyed event and the following conditions are met in the interface where the event occurred:

  • The products have a Packaging Code Type of GTIN-14 with a Packaging UOM of Each.
  • The products have a Target Market of Russia.
  • A Destruction Method is specified.
  • In Product Master Data, the products must:
    • Have a PackagingCodeType of GTIN-14 with a PackagingUOM (unit of measure) of each.
    • Have a TargetMarket of RU.
  • A tl:destructionMethod is specified.

Use any of the following messages to generate the 542 - Destruction report:

  • In Product Master Data, the products must:
    • Have a PackagingCodeType of GTIN-14 with a PackagingUOM (unit of measure) of each.
    • Have a TargetMarket of RU.
  • A DestructionMethod is specified.

Use any of the following messages to generate the 542 - Destruction report:

Generating the report

  1. Hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Status Update drop-down and then select Decommission Serial Numbers.
  3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
  4. Enter the identifier of the MAH for the product that is being decommissioned in the Reporting Party field.
  5. Enter the identifier of the company or location decommissioning the serial numbers in the Location field.
  6. Select a Destruction Method:
    • Liquid - Dilution Drainage – The ampoule is crushed, and the liquid product is diluted and discharged into industrial sewers (reported as 1 - Liquid Dilution Drainage).
    • Solid - Dilution Discharge – The solid product is crushed, diluted, and discharged into industrial sewers (reported as 2 - Solid Dilution Discharge).
    • Incineration – The product is consumed in an incinerator (reported as 3 - Incineration).
  7. Select the Reason Code to apply to the decommissioned serial numbers:
    • Damaged – The product is damaged.
    • Defective – The product does not function as intended.
    • Dispensed – The product is dispensed.
    • Disposed – The product is disposed.
    • Expired – The product reached its expiration date.
    • Misplaced – The product is missing.
    • Inappropriately Stored – The product has been stored improperly and is no longer fit for sale.
    • Recalled – The product is recalled by the Pharmaceutical Manufacturer.
    • Repackaged – The product is repackaged from a different source product.
    • Returned – The product has been returned and cannot be resold.
    • Sampled – The product is sampled for quality testing.
    • Sampled - Archival – The product is sampled to store as a record.
    • Sampled - Clinical Study – The product is sampled for a clinical study.
    • Sampled - Customs Control – The product is sampled for inspection control by customs authorities.
    • Sampled - Federal Inspection – The product is sampled for federal inspection.
    • Sampled - Marketing Demonstration – The product is used in a marketing demonstration.
    • Sampled - Pharmaceutical Study – The product is sampled for a post-registration pharmaceutical study, to support submitted changes to a dossier.
    • Sampled By Authorities – The product is sampled by government authorities.
    • Sampled - Selective Control – The product is sampled by health authorities as needed to ensure quality standards.
    • Stolen – The product is stolen.
    • Spoilage – The product is spoiled due to exposure (e.g. heat, oxygen, moisture, microrganisms).
    • Withdrawn – The product is removed from the market by the Pharmaceutical Manufacturer.
    • Withdrawn - Experiment – The product is withdrawn from the market during the course of an experiment.
    • Other – The product is decommissioned for a reason that is not listed.
  8. Enter the Reason Description for the decommissioning (optional, maximum 100 characters).
  9. Specify the Transaction IDs for the decommissioning:
    1. Specify a Destruction document:
      1. Select Add Another in the Transaction IDs table header.
      2. Select Destruction as the Identifier Type.
      3. Enter the Identifier Value of the Destruction document.
      4. Enter the Document Date printed on the Destruction document.
    2. Specify additional Transaction IDs (optional):
      1. Select Add Another in the Transaction IDs table header.
      2. Select an Identifier Type from the drop-down.
      3. Enter the Identifier Value in the text field.
      4. Select the Document Date from the date picker.
  10. Enter the Serial Numbers to be decommissioned by selecting one of the following:
    • Select Upload Serial Numbers from File:
      1. Select Choose File.
      2. Browse for and select the desired CSV file.
        3. The CSV file must be smaller than 50MB and cannot contain headers. Only 1 file can be uploaded per session.

      or

    • Select Scan Serial Numbers:
      • Enter the serial numbers (limit of 30,000 characters).

        or

      • Scan the serial numbers (limit of 30,000 characters) with an external scanner.
  11. Select Automatically Disaggregate Items From Parent Container to disaggregate all decommissioned child items from their parent containers when the decommission event is submitted (optional).

    If selected, the disaggregation event initiates the 913 - Unit Extract report.

  12. Select Submit.

    The serial numbers are decommissioned and updated with the selected reason code.

  1. Hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Status Update drop-down and then select Destroy Product
  3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
  4. Enter the identifier of the MAH for the product that is being decommissioned in the Reporting Party field.
  5. Enter the identifier of the company or location destroying the product in the Location field.
  6. Select a Destruction Method:
    • Liquid - Dilution Drainage – The ampoule is crushed, and the liquid product is diluted and discharged into industrial sewers (reported as 1 - Liquid Dilution Drainage).
    • Solid - Dilution Discharge – The solid product is crushed, diluted, and discharged into industrial sewers (reported as 2 - Solid Dilution Discharge).
    • Incineration – The product is consumed in an incinerator (reported as 3 - Incineration).
  7. Select the Reason Code to apply to the destroyed items:
    • Damaged – The product is damaged.
    • Defective – The product does not function as intended.
    • Dispensed – The product is dispensed.
    • Disposed – The product is disposed.
    • Expired – The product reached its expiration date.
    • Misplaced – The product is missing.
    • Inappropriately Stored – The product has been stored improperly and is no longer fit for sale.
    • Recalled – The product is recalled by the Pharmaceutical Manufacturer.
    • Repackaged – The product is repackaged from a different source product.
    • Returned – The product has been returned and cannot be resold.
    • Sampled – The product is sampled for quality testing.
    • Sampled - Archival – The product is sampled to store as a record.
    • Sampled - Clinical Study – The product is sampled for a clinical study.
    • Sampled - Customs Control – The product is sampled for inspection control by customs authorities.
    • Sampled - Federal Inspection – The product is sampled for federal inspection.
    • Sampled - Marketing Demonstration – The product is used in a marketing demonstration.
    • Sampled - Pharmaceutical Study – The product is sampled for a post-registration pharmaceutical study, to support submitted changes to a dossier.
    • Sampled By Authorities – The product is sampled by government authorities.
    • Sampled - Selective Control – The product is sampled by health authorities as needed to ensure quality standards.
    • Stolen – The product is stolen.
    • Spoilage – The product is spoiled due to exposure (e.g. heat, oxygen, moisture, microrganisms).
    • Withdrawn – The product is removed from the market by the Pharmaceutical Manufacturer.
    • Withdrawn - Experiment – The product is withdrawn from the market during the course of an experiment.
    • Other – The product is decommissioned for a reason that is not listed.
  8. Enter the Reason Description for the destruction (optional, maximum 100 characters).
  9. Specify the Transaction IDs for the destruction:
    1. Specify a Destruction document:
      1. Select Add Another in the Transaction IDs table header.
      2. Select Destruction as the Identifier Type.
      3. Enter the Identifier Value of the Destruction document.
      4. Enter the Document Date printed on the Destruction document.
    2. Specify additional Transaction IDs (optional):
      1. Select Add Another in the Transaction IDs table header.
      2. Select an Identifier Type from the drop-down.
      3. Enter the Identifier Value in the text field.
      4. Select the Document Date from the date picker.
  10. Enter the Serial Numbers whose items are destroyed by selecting one of the following:
    • Select Upload Serial Numbers from File:
      1. Select Choose File.
      2. Browse for and select the desired CSV file.
        3. The CSV file must be smaller than 50MB and cannot contain headers. Only 1 file can be uploaded per session.

      or

    • Select Scan Serial Numbers:
      • Enter the serial numbers (limit of 30,000 characters).

        or

      • Scan the serial numbers (limit of 30,000 characters) with an external scanner.
  11. Select Automatically Disaggregate Items From Parent Container to disaggregate all destroyed child items from their parent containers when the destruction event is submitted (optional).

    If selected, the disaggregation event initiates the 913 - Unit Extract report.

  12. Select Submit.

    The items are destroyed and updated with the selected reason code.

Compliance report details

  • Report Date – The date and time that the report generated.
  • Report ID – The report's MDLP document ID.
  • Report Type – 542 - Destruction.
Field Description Sourced From MDLP Report Element
Reporting Party ID The 14-character Russia Account Number of the MAH for the product that is decommissioned or destroyed. Reporting Party in the decommissioning or destruction event. subject_id
Reporting Party Name The name of the MAH for the product that is decommissioned or destroyed. Company Master Data, the name associated with the Reporting Party. Not reported
Destruction Date The date that the items are decommissioned or destroyed. The date of the decommissioning or destruction event. operation_date
Destruction Type The method used to destroy the product. Displays as one of the following:
  • 1 - Liquid Dilution Drainage – The ampoule is crushed, and the liquid product is diluted and discharged into industrial sewers.
  • 2 - Solid Dilution Discharge – The solid product is crushed, diluted, and discharged into industrial sewers.
  • 3 - Incineration – The product is consumed in an incinerator.
 Destruction Method in the decommissioning or destruction event. destruction_method
Destruction Organization IDs The INN and tax registration code of the location decommissioning or destroying the items. The RU - INN identifier Value and Tax Registration Code from Partner Master Data for the Location in the decommissioning or destruction event. destruction_org
Destruction Organization Name The name of the location decommissioning or destroying the items. Partner Master Data, the name associated with the identifier of the Location. Not reported
Destruction Document Number The number on the contract service agreement to destroy the items. Identifier Value of the Destruction Transaction ID in the decommissioning or destruction event. doc_num
Destruction Document Date The date on the contract service agreement to destroy the items. Document Date of the Destruction Transaction ID in the decommissioning or destruction event. doc_date
  • Response Received – The date and time that TraceLink received a response message from MDLP.
  • Response Type – The response code from MDLP.
  • Status – The status of the report with MDLP.
  • Error Code – The error code returned by MDLP, if applicable.
  • Error Description – The description of the associated Error Code.