Status Update How-Tos

• Reserved
• Encoded
• Decommissioned

1. Select the Status Update option on the left.
2. Select the Commission Serial Numbers link.

   The Commission Serial Numbers screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Select the AI(00) barcode identifier type from the Encoding Format drop-down.
5. Enter the site-level Location SGLN (Serialized Global Location Number) of the commissioning location.

   Be aware of the following:

   • The format is the numeric component only, without the urn prefix (e.g. [CompanyPrefix].[LocationReference].[Extension]).
   • If the SGLN is the primary location of the GLN, enter an [Extension] value of "0" (e.g. 8888882.02867.0).
6. Enter the GS1 Company Prefix associated with the SSCC serial numbers being commissioned.

7. Select the Filter Value associated with the SSCC packaging level.

   This value is typically the same as the Extension Digit in the SSCC code.

8. Enter the Lot Number associated with the Packaging Code, Country Drug Code, or Internal Material Number used to identify the serial numbers for the commission event (optional).
9. Enter the lot's Expiration Date (optional).
10. Enter the lot's Manufacturing Date (optional).

11. Enter the product's Internal Material Number from the Pharmaceutical Manufacturer's internal system, as entered in Product Master Data (optional).

12. Enter the National Drug Code of the country where the item will be sold in the Country Drug Code field (optional).
13. Select a packaging hierarchy level for the serial numbers from the Packaging UOM (unit of measure) drop-down (optional):
    • Innerpack/Bundle - A group of the smallest salable unit of the product.
    • Case/Shipper - A group of innerpacks/bundles or a group of eaches if the packaging hierarchy does not include innerpacks/bundles.
    • Pallet - The level of packaging with cases grouped together on a pallet.
14. Enter the Serial Numbers to be commissioned by selecting one of the following:
• Select Upload Serial Numbers from File:
  1. Select the Choose File button.
  2. Browse for and select the desired CSV file.

  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 in the text field (limit of 30,000 characters).

    or

  • Scan the serial numbers in the text field (limit of 30,000 characters) with an Edge device.
15.  Select the Submit button.

    TraceLink asynchronously processes the request. The confirmation message "Your serial number commission request has been received and is being processed." displays at the top of a blank Commission Serial Numbers screen.

1. Select the Status Update option on the left.
2. Select the Commission Serial Numbers link.

   The Commission Serial Numbers screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Select the barcode identifier type from the Encoding Format drop-down:
   • AI(01)(21) - The barcode representation of a serialized GTIN or NTIN number and the equivalent of the SGTIN-96 scheme.
   • CN-EDMC - The barcode representation of the China number encoding format.
5. Enter the site-level Location SGLN (Serialized Global Location Number) of the commissioning location.

   Be aware of the following:

   • The format is the numeric component only, without the urn prefix (e.g. [CompanyPrefix].[LocationReference].[Extension]).
   • If the SGLN is the primary location of the GLN, enter an [Extension] value of "0" (e.g. 8888882.02867.0).

6. Enter the Packaging Code assigned to a specific level of packaging aggregation for the product.

7. Enter the Lot Number associated with the Packaging Code, Country Drug Code, or Internal Material Number used to identify the serial numbers for the commission event.

8. Enter the new Item Code associated with the commissioned lot number.

9. Enter the product's Internal Material Number from the Pharmaceutical Manufacturer's internal system, as entered in Product Master Data (optional).
10. Enter the lot's Expiration Date (optional).
11. Enter the National Drug Code of the country where the item will be sold in the Country Drug Code field (optional).

    Country Drug Code is required if an Internal Material Number has not been provided.

12. Enter the lot's Manufacturing Date (optional).
13. Enter the Serial Numbers to be commissioned by selecting one of the following:
• Select Upload Serial Numbers from File:
  1. Select the Choose File button.
  2. Browse for and select the desired CSV file.

  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 in the text field (limit of 30,000 characters).

    or

  • Scan the serial numbers in the text field (limit of 30,000 characters) with an Edge device.
14.  Select the Submit button.

    TraceLink asynchronously processes the request. The confirmation message "Your serial number commission request has been received and is being processed." displays at the top of a blank Commission Serial Numbers screen.one of the following screens:

Serial Number Format Requirements:

When scanning, entering, or uploading a file to populate serial numbers, each number must be:

• On a separate row.
• Without any special characters.
• In one of the following formats:
  • SGTIN Serial Numbers
    • Used for:
      • Items
      • Innerpacks
      • Bundles
      • Cases and Shippers
    • The format is the AI(01)(21) serial number in barcode format:
      1. First is the 01 Application Identifier
      2. Followed by the GTIN-14 number
      3. Followed by the 21 Application Identifier
      4. Followed by the serial number

         Example: 010088202401033921725368249416

  • SSCC Serial Numbers
    • Used for:
      • Pallets
      • Mixed cases
    • The format is the AI(00) serial number in barcode format:
      1. First is the 00 Application Identifier
      2. Followed by the SSCC-18 code

         Example: 00008820200000050254

  • China EDMC Codes
    • Used for:
      • Items
      • Innerpacks
      • Bundles
      • Cases and Shippers
    • The format is the full 20-digit China serial number, e.g. 81102302020117515452.

1. Select the Status Update option on the left.
2. Select the Update Serial Number Status link.

   The Update Serial Number Status screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Select the new Serial Number Status from the drop-down:
• Commissioned - The product associates to a serial number and lot.
• Decommissioned - The product no longer associates to a serial number.
• Destroyed - The product and related serial numbers are terminated.
• Encoded - The serial numbers are sent for pre-printing on the product labels after provisioning.
• Registered - The product's serial number is registered during repackaging.
• Reserved - The serial number's packaging location is assigned.
• Unreserved - The serial number no longer has a packaging location assigned to it.
5. Select the Item Status for the product associated with the serial numbers:

   Only enabled and required if the serial number state is Commissioned.

   • Available - The item is available for picking.
   • Blocked - The item is unavailable for picking.
   • Pending Receipt - The transfer of ownership is in an interim state because the shipment awaits receipt confirmation at the receiving location.
   • Picked - There is an item reservation against a specific outbound delivery indicating item picking is complete.
   • Received - There is an item reservation against a specific outbound delivery indicating items are received.
   • Shipped - The transfer of ownership is in an interim state because the shipment is in transit to the receiving location.
   • Under Investigation - The item is quarantined or in a holding state due to a product investigation. The serial number cannot be included in a sales shipment.

   Updating the serial numbers' Item Status triggers a government compliance report when the following conditions are met:

   • If a serial number was previously reported to the EU Hub as Locked and its Item Status is updated to Available, TraceLink triggers an Active - Update Product Pack State report.
   • If a serial number was previously reported to the EU Hub as Sampled and its Item Status is updated to Available, TraceLink triggers an Active - Update Product Pack State report.
   • If a serial number was previously reported to the EU Hub as Active and its Item Status is updated to Under Investigation, TraceLink triggers a Locked - Update Product Pack State report.
6. Select the Reason Code for the update (optional):

   Some Reason Code options are unavailable, depending on the Serial Number Status selected. If the Serial Number Status is:

   • Commissioned or Registered: Dispensed, Disposed, Repackaged, and Sampled by Authorities are unavailable.
   • Decommissioned: Quality Released is unavailable.
   • Destroyed: Quality Released, Sampled by Authorities, Repackaged, Dispensed, Stolen, and Withdrawn are unavailable.
   • Reserved or Unreserved: The Reason Code field is disabled.
   • Damaged – The product is damaged.
   • Recalled - The product is recalled by the Pharmaceutical Manufacturer.
   • Expired - The product reached its expiration date.
   • Sampled – The product is sampled for quality testing.
   • Misplaced – The product is missing.
   • Dispensed - The product is dispensed.
   • Disposed – The product is disposed.
   • Repackaged - The product is repackaged from a different source product.
   • Sampled by Authorities - The product is sampled by government authorities.
   • Stolen – The product is stolen.
   • Withdrawn - The product is removed from the market by the Pharmaceutical Manufacturer.
   • Quality Released - The product's quality inspection is complete.
7. Select an Update Type from the drop-down:
• Product Status Update - The product's status changed, and the serial number status needs to be updated accordingly.
• Modifying Incorrect Product Status - The current serial number status is incorrect.
8. Enter a Reason Description, with a maximum of 100 characters (optional).
9. Enter the Serial Numbers to be commissioned by selecting one of the following:
• Select Upload Serial Numbers from File:
  1. Select the Choose File button.
  2. Browse for and select the desired CSV file.

  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 in the text field (limit of 30,000 characters).

    or

  • Scan the serial numbers in the text field (limit of 30,000 characters) with an Edge device.
10. Select the Submit button.

    TraceLink updates the serial number status, item status, and item attributes for the container, child, and sub-child items. The confirmation message "The status of the [Number of Serial Numbers] serial numbers you entered has been updated to [Serial Status] with a reason code of [Reason Code]." displays at the top of a blank Update Serial Number Status screen.one of the following screens:

Use this function to reassign all serial numbers in a given lot to an existing lot number in the TraceLink system to which the serial numbers should have originally been commissioned.

1. Select the Status Update option on the left.

2. Select the Update Lot Information link.

   The Update Lot Information screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Select the Reassign Serial Numbers to an Existing Lot radio button.
5. Enter the product's GTIN, NTIN, or Internal Material Number in the Item Code type-ahead field.
6. Enter the Lot Number associated with the Packaging Code, Country Drug Code, or Internal Material Number, which identifies the serial numbers to update.
7. Enter the correct lot number that all serial numbers must be reassigned to in the Move To Lot field.
8. Select the Submit button.

   The "Confirm Update" dialog box displays.

9. Select the Confirm button.

   The following message displays on the Update Lot Information screen: “TraceLink is updating the information for Lot [Lot Number]. See Info Exchange for the status.”

Use this function to correct lot information with a new Lot Number, Expiration Date, or Barcode Expiration Date that is not currently in the TraceLink system.

1. Select the Status Update option on the left.

2. Select the Update Lot Information link.

   The Update Lot Information screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Select the Correct the Lot Information radio button.
5. Enter the product's GTIN, NTIN, or Internal Material Number in the Item Code type-ahead field.
6. Enter the Lot Number associated with the Packaging Code, Country Drug Code, or Internal Material Number, which identifies the serial numbers for the update.
7. Select the Search button.

   A table displays, containing the Lot Number and Expiration Date of the previously entered lot.

8. In the Correct Values column:

   1. Enter the new Lot Number (required if Expiration Date is blank).
   2. Enter the correct Item Code associated with the Lot Number.

   3. Select or enter the new Expiration Date, Barcode Expiration Date and/or Extended Expiration Date to correctly associate all serial numbers in the previously-defined lot.

      Once a Barcode Expiration Date is added to the serialized items, only updates to this value generate EU Update Product Pack Data reports. To report a new Expiration Date enter the year, month, and day in the Barcode Expiration Date field.

9. Select the Submit button.

   The "Confirm Update" dialog box displays.

10. Select the Confirm button.

    The following message displays on the Update Lot Information screen: “TraceLink is updating the information for Lot [Lot Number]. See Info Exchange for the status.”

A Barcode Expiration Date is used for EU compliance reporting and should only be provided when there is a discrepancy between the commissioned, or current, Expiration Date and the expiration date returned when an item's packaging is scanned.

1. Select the Status Update option on the left.

2. Select the Update Lot Information link.

   The Update Lot Information screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Select the Correct the Lot Information radio button.
5. Enter the product's GTIN, NTIN, or Internal Material Number in the Item Code type-ahead field.
6. Enter the Lot Number associated with the Packaging Code, Country Drug Code, or Internal Material Number, which identifies the serial numbers for the update.
7. Select the Search button.

   A table displays, containing the Lot Number and Expiration Date of the previously entered lot.

8. In the Correct Values column enter the Barcode Expiration Date on the serialized items that differs from the commissioned, or current, expiration date of the lot.

9. Select the Submit button.

   The "Confirm Update" dialog box displays.

10. Select the Confirm button.

    The following message displays on the Update Lot Information screen: “TraceLink is updating the information for Lot [Lot Number]. See Info Exchange for the status.”

1. Select the Status Update option on the left.

2. Select the Set Product Release Status link.

   The Set Product Release Status screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Enter the product's GTIN, NTIN, or Internal Material Number in the Item Code type-ahead field.
5. Enter the Lot Number associated with the Packaging Code, Country Drug Code, or Internal Material Number, which identifies the serial numbers to be released.
6. Enter the identifier of the company or location testing the quality of the product in the Quality Control Entity field, as entered in Product Master Data (optional).
7. Enter the business transaction identifier and type in the Transaction IDs table (optional):

   1. Select the Add Another link in the table header.

   2. Select an Identifier Type from the drop-down.

   3. Enter an Identifier Value in the text field.

   4. Select the Document Date that is printed on the corresponding transaction document from the date picker.

8. Enter the quantity of serial numbers commissioned at each packaging level of the lot in the Production Quantity table (optional):

   If product is involved in a Commissioning or Aggregation event that is currently processing, TraceLink will park and retry the operation to verify the Production Quantity details for a given Lot Number before triggering any configured compliance reports.

   1. Identify items at the Each level:

      1. Select Add Level.
      2. Select the Each's GTIN, NTIN, or CN-Subtype identifier of the serial numbers assigned to the product's packaging level from the Packaging Code down-drop, as entered in Product Master Data.
      3. Enter the amount of serial numbers expected in the Packaging Level in the Quantity field.

   2. Identify items at another Packaging Level (optional):

      1. Select Add Level.
      2. Select a Packaging Level from the drop-down:
         • Each - The smallest salable unit a product can be serialized in.
         • Inner Pack/Bundle - Contains a group of eaches.
         • Case/Shipper - The next level of packaging. Contains a group of Inner Packs/Bundles.
           • SSCC - Enabled when Case/Shipper is selected.
             • If SSCC is selected, enter a GS1 Company Prefix in the Packaging Code field.
             • If SSCC is not selected, enter a GTIN, NTIN, or CN-ResCode in the Packaging Code field.
         • Pallet - The largest packaging level. Contains a group of Cases/Shippers.
      3. Select a Packaging Code from the drop-down.
      4. Enter the Quantity in the text field.
9. Select the Submit button.

   TraceLink asynchronously processes the request. The confirmation message "The request to update the status of all serial numbers in Lot [Lot Number] to [Quality Released] has been submitted. This operation could take several minutes to process depending on the size of the lot. You will be notified when the operation completes." displays at the top of a blank Set Product Release Status screen.one of the following screens:

• See Set Product Release Status for information about country specific Product Release requirements.

1. Select the Status Update option on the left.

2. Select the Set Market Release Status link.

   The Set Market Release Status screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Enter the product's GTIN, NTIN, or Internal Material Number in the Item Code type-ahead field.
5. Enter the Lot Number associated with the Packaging Code, Country Drug Code, or Internal Material Number, which identifies the serial numbers to be released.
6. Enter the identifier of the company or location performing the market release in the Location field, as entered in Product Master Data (optional).
7. Select Full Lot from the Scope radio buttons to indicate that the entire lot of product is being released into the Target Market.
8. Enter the business transaction identifier and type in the Transaction IDs table (optional):

   1. Select the Add Another link in the table header.

   2. Select an Identifier Type from the drop-down.

   3. Enter an Identifier Value in the text field.

   4. Select the Document Date that is printed on the corresponding transaction document from the date picker.

9. Enter the quantity of serial numbers commissioned at each packaging level of the lot in the Production Quantity table (optional):

   If product is involved in a Commissioning or Aggregation event that is currently processing, TraceLink will park and retry the operation to verify the Production Quantity details for a given Lot Number before triggering any configured compliance reports.

   1. Identify items at the Each level:

      1. Select Add Level.
      2. Select the Each's GTIN, NTIN, or CN-Subtype identifier of the serial numbers assigned to the product's packaging level from the Packaging Code down-drop, as entered in Product Master Data.
      3. Enter the amount of serial numbers expected in the Packaging Level in the Quantity field.

   2. Identify items at another Packaging Level (optional):

      1. Select Add Level.
      2. Select a Packaging Level from the drop-down:
         • Each - The smallest salable unit a product can be serialized in.
         • Inner Pack/Bundle - Contains a group of eaches.
         • Case/Shipper - The next level of packaging. Contains a group of Inner Packs/Bundles.
           • SSCC - Enabled when Case/Shipper is selected.
             • If SSCC is selected, enter a GS1 Company Prefix in the Packaging Code field.
             • If SSCC is not selected, enter a GTIN, NTIN, or CN-ResCode in the Packaging Code field.
         • Pallet - The largest packaging level. Contains a group of Cases/Shippers.
      3. Select a Packaging Code from the drop-down.
      4. Enter the Quantity in the text field.
10. Select the Submit button.

    The Set Market Release Status screen refreshes with one of the following confirmation messages:

    • If the Scope is Full Lot and Production Quantity is blank, "The request to assign the Market Released Attribute to all serial numbers in Lot [Lot Number] has completed." displays at the top of the screen.
    • If the Scope is Full Lot and Production Quantity is included, "The request to assign the Market Released Attribute to all serial numbers in Lot [Lot Number] is being processed. See Info Exchange for its status." displays at the top of the screen.

1. Select the Status Update option on the left.

2. Select the Set Market Release Status link.

   The Set Market Release Status screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Enter the product's GTIN, NTIN, or Internal Material Number in the Item Code type-ahead field.
5. Enter the Lot Number associated with the Packaging Code, Country Drug Code, or Internal Material Number, which identifies the serial numbers to be released.
6. Enter the identifier of the company or location performing the market release in the Location field, as entered in Product Master Data (optional).
7. Select Partial Lot from the Scope radio buttons to indicate that only a portion of the lot's serial numbers are being released into the Target Market.
8. Enter the released Serial Numbers by selecting one of the following:
   • Select Upload Serial Numbers from File:
     1. Select the Choose File button.
     2. Browse for and select the desired CSV file.

     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 in the text field (limit of 30,000 characters).

       or

     • Scan the serial numbers in the text field (limit of 30,000 characters) with an Edge device.
9. Enter the business transaction identifier and type in the Transaction IDs table (optional):

   1. Select the Add Another link in the table header.

   2. Select an Identifier Type from the drop-down.

   3. Enter an Identifier Value in the text field.

   4. Select the Document Date that is printed on the corresponding transaction document from the date picker.
10. Select the Submit button. The Set Market Release Status screen refreshes and the confirmation message "The request to assign the Market Released Attribute to the specified serial numbers in Lot [Lot Number] has completed." displays at the top of the screen.

1. Select the Status Update option on the left.

2. Select the Take Product Sample link.

   The Take Product Sample screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Enter the country the product is inspected for in the Inspection Country Code type-ahead field.
5. Enter the company or location sampling the product in the Sampling Entity type-ahead field (required if Inspection Country Code is Russia).
6. Select one of the following reasons the product is sampled from the Sampling Reason Code drop-down (required if Inspection Country Code is Russia):
   • Archival Sample - The product is sampled to store as a record.
   • Conformity Control - The product is sampled by health authorities when imported to ensure quality standards.
   • Selective Control - The product is sampled by health authorities at random to ensure quality standards.
7. Enter the reason for the product sample (maximum 100 characters) in the Reason Description text field (optional).
8. Enter the Serial Numbers by selecting one of the following:
• Select Upload Serial Numbers from File:
  1. Select the Choose File button.
  2. Browse for and select the desired CSV file.

  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 in the text field (limit of 30,000 characters).

    or

  • Scan the serial numbers in the text field (limit of 30,000 characters) with an Edge device.
9. Select the Submit button.

   TraceLink disaggregates the sample product if the serial number is aggregated to a parent container serial number. The confirmation message "The status of the [quantity of serial numbers] serial numbers you entered has been updated to Sampled." displays at the top of a blank Take Product Sample screen.

1. Select the Status Update option on the left.
2. Select the Destroy Product link.

   The Destroy Product screen displays.

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 company or location reporting the event in the Reporting Party field, as entered in Product Master Data (optional).
5. Enter the identifier of the company or location decommissioning the product in the Location field.
6. Select one of the following methods used to eliminate the product from the Destruction Method drop-down (optional):
   • Liquid - Dilution and Drainage - The ampoule is crushed, and the liquid product is diluted and discharged into industrial sewers.
   • Solid - Dilution and Discharge - The solid product is crushed, diluted, and discharged into industrial sewers.
   • Incineration - The product is consumed in an incinerator.
7. Select an attribute to be applied to the item when it is destroyed from the Reason Code drop-down:
   • 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 - Marketing Demonstration - The product is used in a marketing demonstration.
   • Sampled by Authorities - The product is sampled by government authorities.
   • Sampled - Pharmaceutical Study - The product is sampled for a post-registration pharmaceutical study, to support submitted changes to a dossier.
   • Sampled - Federal Inspection - The product is sampled for federal inspection.
   • 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 destroyed for a reason that is not listed.
8. Enter the reason for the destroy event (maximum 100 characters) in the Reason Description text field (optional).
9. Enter the business transaction identifier and type in the Transaction IDs table (optional):

   1. Select the Add Another link in the table header.

   2. Select an Identifier Type from the drop-down.

   3. Enter an Identifier Value in the text field.

   4. Select the Document Date that is printed on the corresponding transaction document from the date picker.
10. Enter the Serial Numbers to be destroyed by selecting one of the following:
• Select Upload Serial Numbers from File:
  1. Select the Choose File button.
  2. Browse for and select the desired CSV file.

  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 in the text field (limit of 30,000 characters).

    or

  • Scan the serial numbers in the text field (limit of 30,000 characters) with an Edge device.
11. Select the Automatically disaggregate items from parent container checkbox to disaggregate all destroyed child items from their parent containers when the destroy event is submitted (optional).
12. Select the Submit button.

    The confirmation message "The status of the [Number of Serials Numbers] serial numbers you entered has been updated to Destroyed with a reason code of [Reason Code]." displays at the top of a blank Destroy Product screen.one of the following screens:

1. Select the Status Update option on the left.
2. Select the Decommission Serial Numbers link.

   The Decommission Serial Numbers screen displays.

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 company or location reporting the event in the Reporting Party field, as entered in Product Master Data (optional).
5. Enter the identifier of the company or location decommissioning the product in the Location field.
6. Select one of the following methods used to eliminate the product from the Destruction Method drop-down (optional):

   Only enabled if Reason Code is set to Damaged, Defective, Expired, Inappropriately Stored, Recalled, Returned, Sampled, Spoilage, or Withdrawn.

   • Liquid - Dilution and Drainage - Dilution and Drainage - The ampoule is crushed, and the liquid product is diluted and discharged into industrial sewers.
   • Solid - Dilution and Discharge - Dilution and Discharge - The solid product is crushed, diluted, and discharged into industrial sewers.
   • Incineration - The product is consumed in an incinerator.
7. Select one of the following attributes to apply to the item when it is decommissioned from the Reason Code drop-down:
   • 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 - Marketing Demonstration - The product is used in a marketing demonstration.
   • Sampled by Authorities - The product is sampled by government authorities.
   • Sampled - Pharmaceutical Study - The product is sampled for a post-registration pharmaceutical study, to support submitted changes to a dossier.
   • Sampled - Federal Inspection - The product is sampled for federal inspection.
   • 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 for the decommission event (maximum 100 characters) in the Destroy Reason text field (optional).
9. Enter the business transaction identifier and type in the Transaction IDs table (optional):

   1. Select the Add Another link in the table header.

   2. Select an Identifier Type from the drop-down.

   3. Enter an Identifier Value in the text field.

   4. Select the Document Date that is printed on the corresponding transaction document 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 the Choose File button.
  2. Browse for and select the desired CSV file.

  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 in the text field (limit of 30,000 characters).

    or

  • Scan the serial numbers in the text field (limit of 30,000 characters) with an Edge device.
11. Select the Automatically disaggregate items from parent container checkbox to disaggregate all destroyed child items from their parent containers when the decommission event is submitted (optional).
12. Select the Submit button.

    The confirmation message "The status of the [Number of Serials Numbers] serial numbers you entered has been updated to Decommissioned with a reason code of [Reason Code]." displays at the top of a blank Decommission Serial Numbers screen.one of the following screens:

1. Select the Status Update option on the left.

2. Select the Set Recall Status link.

   The Set Recall Status screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. In the "Product Information" section:
   1. Enter the Internal Material Number or Country Drug Code of the recalled product in the Item Code field.
   2. Enter the Lot Number associated with the Country Drug Code or Internal Material Number, which identifies the serial numbers to recall.
   3. Select the Full lot/batch radio button.
5. In the "Recall Information" section:
   1. Select the Set Recall Status radio button.
   2. Deselect any Target Markets the product is not recalled from in the Markets field.
   3. Enter the date that all serial numbers associated with lot are recalled on in the Effective Date field.
   4. Enter the reason the lot is recalled from the selected markets in the Reason Description text field (limit 512 characters).
6. Select the Submit button.

   A confirmation dialog box displays.

7. Select the Confirm button.

   The dialog box closes, and the confirmation message: "The request to update the status of serial numbers in Lot [Lot Number] to Recalled has been submitted. This operation could take several minutes to process depending on the size of the lot. Check the outcome of this operation in Info Exchange." displays at the top of the screen.

1. Select the Status Update option on the left.

2. Select the Set Recall Status link.

   The Set Recall Status screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. In the "Product Information" section:
   1. Enter the Internal Material Number or Country Drug Code in the Item Code field to remove the Recall attribute from the product.
   2. Enter the Lot Number associated with the Country Drug Code or Internal Material Number, to identify which serial numbers to remove the Recall attribute from.
   3. Select the Full lot/batch radio button.
5. In the "Recall Information" section:
   1. Select the Undo Recall Status radio button.
   2. Enter the reason the lot is recalled from the selected Target Markets in the Reason Description text field (limit 512 characters).
6. Select the Submit button.

   A confirmation dialog box displays.

7. Select the Confirm button.

   The dialog box closes, and the confirmation message: "The request to update the status of serial numbers in Lot [Lot Number] to Recalled has been submitted. This operation could take several minutes to process depending on the size of the lot. Check the outcome of this operation in Info Exchange." displays at the top of the screen.

1. Select the Status Update option on the left.

2. Select the Set Recall Status link.

   The Set Recall Status screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. In the "Product Information" section:
   1. Enter the Internal Material Number or Country Drug Code of the recalled product in the Item Code field.
   2. Enter the Lot Number associated with the Country Drug Code or Internal Material Number, which identifies the serial numbers to recall.
   3. Select the Partial lot/batch radio button.

      A Partial lot/batch cannot be submitted if an EU FMD Target Market is selected in the Markets list.

   4. Enter the recalled Serial Numbers by selecting one of the following:
      • Select Upload Serial Numbers from File:
        1. Select the Choose File button.
        2. Browse for and select the desired CSV file.

        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 in the text field (limit of 30,000 characters).

          or

        • Scan the serial numbers in the text field (limit of 30,000 characters) with an Edge device.
5. In the "Recall Information" section:
   1. Select the Set Recall Status radio button.
   2. Enter the date that all serial numbers associated with lot are recalled in the Effective Date field.
   3. Enter the reason the serial numbers are recalled from the selected Target Markets in the Reason Description text field (limit 512 characters).
6. Select the Submit button.

   A confirmation dialog box displays.

7. Select the Confirm button.

   The dialog box closes, and the confirmation message: "The request to update the status of serial numbers in Lot [Lot Number] to Recalled has been submitted. This operation could take several minutes to process depending on the size of the lot. Check the outcome of this operation in Info Exchange." displays at the top of the screen.

• See Get Lot Status to download the serial numbers from a previously recalled Partial lot/batch recall.

1. Select the Status Update option on the left.

2. Select the Set Recall Status link.

   The Set Recall Status screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. 1. Enter the Internal Material Number or Country Drug Code in the Item Code field to remove the Recall attribute from the product.
   2. Enter the Lot Number associated with the Country Drug Code or Internal Material Number, to identify which serial numbers to remove the Recall attribute from.
   3. Select the Partial lot/batch radio button.

      Do not enter the serial numbers to undo a partial batch recall.

5. In the "Recall Information" section:
   1. Select the Undo Recall Status radio button.
   2. Enter the same Effective Date used when the serial numbers were originally recalled.
   3. Enter the reason the serial numbers are recalled from the selected Target Markets in the Reason Description text field (limit 512 characters).
6. Select the Submit button.

   A confirmation dialog box displays.

7. Select the Confirm button.

   The dialog box closes, and the confirmation message: "The request to remove the status of Recalled for serial numbers in Lot [Lot Number] has been submitted. This operation could take several minutes to process depending on the size of the lot. Check the outcome of this operation in Info Exchange." displays at the top of the screen.

1. Select the Status Update option on the left.

2. Select the Set Market Withdrawal Status link.

   The Set Market Withdrawal Status screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Enter the identifiers of the withdrawn products in the Item Code table:

   1. Enter the Internal Material Number or Country Drug Code of the Withdrawn product in the Item Code field.

      A reference list of all Target Markets currently entered for the product in Product Master Data displays to the right of the Item Code underneath the Markets column.

   2. Select the Add Item Code link in the table header to add additional Item Codes to the Withdrawal.

5. Select the Set Withdrawal radio button.
6. Deselect any Target Markets the product is not withdrawn from in the Markets field.
7. Enter the date that all lots associated with Item Code(s) are withdrawn in the Effective Date field.
8. Enter the reason that the products are withdrawn from the selected Target Markets in the Reason Description text field (limit 512 characters).
9. Select the Submit button.

   A confirmation dialog box displays.

10. Select the Confirm button.

    The dialog box closes, and the confirmation message: "The request to update the lots to Withdrawn has been submitted. This operation could take several minutes to process depending on the volume of serial numbers for this item. Check the outcome of this operation in Info Exchange." displays at the top of the screen.

1. Select the Status Update option on the left.

2. Select the Set Market Withdrawal Status link.

   The Set Market Withdrawal Status screen displays.

3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
4. Enter the identifiers of the products the Withdrawn attribute is removed from in the Item Code table:

   1. Enter the Internal Material Number or Country Drug Code in the Item Code field item to remove the Withdrawal attribute from the product.

      A reference list of all Target Markets currently entered for the product in Product Master Data displays to the right of the Item Code underneath the Markets column.

   2. Select the Add Item Code link in the table header to add additional Item Codes to the Undo Withdrawal.

5. Select the Undo Withdrawal radio button.

6. Enter the reason that the Withdrawn status is removed from the given Item Codes in the Reason Description text-field (limit 512 characters).

7. Select the Submit button.

   A confirmation dialog box displays.

8. Select the Confirm button.

   The dialog box closes, and the confirmation message: "The request to remove the status of Withdrawn has been submitted. This operation could take several minutes to process depending on the volume of serial numbers for this item. Check the outcome of this operation in Info Exchange." displays at the top of the screen.