04 Dec 09 Creating and Managing a Stability Study (OPM Quality)

The Stability Study window lets you create and manage a stability study. Refer to the “Managing the Stability Study Lifecycle” topic for an overview of the creation and management of a stability study.

To create a stability study, enter preliminary information about the study including its document number, description, and storage condition plan. Specify the process quality-enabled item, item revision if the item is revision-controlled, and its base item specification to test in a quality laboratory.

Once the study is created, assign material sources to the study and create all the variants to investigate. At least one material source is required to create a stability study. Once the stability study is underway, use this window to view other pertinent information about the study, including its actual and revised start and end dates. This window also serves as a repository for assigned shelf life recommendations.

You can use folders and flexfields with this window.

See: Oracle Applications User’s Guide and Oracle Applications Flexfields Guide

Prerequisites

• Set up document numbering for the organization that owns the stability study by selecting the stability study Assignment Type as Manual or Automatic in the Process Quality Parameters window.
  
• Create a storage condition plan.
• Create a master item specification for stability testing.
• Identify at least one material source for the stability study.
• Identify at least one storage package for the stability study.
• Enable the stability study workflows as described in “Appendix C.”

To create a stability study:

• Navigate to the Stability Study window. The stability study owner organization or the context organization displays in the window title. Select a different context organization using the Organizations window.
• Enter Study as the stability study number if you select the stability study document numbering Assignment Type as Manual in the Process Quality Parameters window. If you select the Assignment Type as Automatic, then this field is protected. The stability study number is automatically assigned and displays when you save the window.
• Enter a Description for the stability study.
• Choose Change Status from the Actions menu of the Stability Study window to change the stability study status, after entering all relevant information, and saving the stability study with the default Status of New. The Status Approval workflow must be enabled for stability study approval. You can request the following actions in the order presented from the Actions menu:
  • Approved Launch to launch the stability study.
  • Canceled to initiate the stability study cancellation process. The response to this change depends on the status of the current stability study. It can be canceled from an approved plan, an approved launch, or an in progress study.
    Refer to the “OPM Quality Stability Study Change Status Workflow” topic in “Appendix C” for an explanation of the stability study workflow statuses.
  • Stability Study Plan Approved to approve the planned stability study.
    Required.
• Enter the Storage Condition Plan to use for the stability study.
  Refer to the “Creating a Storage Condition Plan” topic for more information on how to structure a plan for the storage conditions. Required.
• Enter the Item as the material tested in the stability study. The item can be an engineering item, but it must be active and lot-controlled. The initial sample material tested must be the same as the item entered here. The item must be set up as process quality-enabled in the Item Master. The item Description displays as it appears on the Item Master. Required.
• Enter the item Revision, if the item is revision-controlled. Required. This field is disabled if the item is not revision-controlled in Oracle Inventory.
• Enter the Master Item Spec as the item specification containing the list of tests performed throughout the entire stability study. The Version displays. The Master Item Spec must be a base specification, and it must have a status of:
  • Approved for Lab Use, for a laboratory item such as an engineering item
  • Approved for General Use, for a production item
    This specification serves as the default item specification when variants are loaded initially.
    Required.
• Enter the inventory organization defined as the Quality Lab. Required.
• Enter the Owner of the stability study. This field defaults to the user who creates the stability study. The user must be associated with the stability study lab organization. The individual who creates the stability study can specify the owner. Required.
• Enter the Notification Lead Time as the amount of advance notice you need prior to each scheduled testing time point using the OPM Stability Study Time Point Scheduling Notification workflow. For example, if a testing time point is scheduled for March 15, and you enter a 3-day notification lead time, you are notified of the scheduled time point on March 12. The notification lead time applies to all time points for all variants.
• Enter Testing Grace Period as the lag time that can be added to each scheduled time point to create a window of opportunity for testing the item. If testing is not done within this testing grace period, then the Stability Study Late Time Point Scheduling Notification starts to notify appropriate individuals that testing is late. The testing grace period applies to all time points for all variants.
  Variant
• Enter Material Sources as the required number of material sources for the stability study. This entry must be a whole positive integer greater than zero. The default for this field is 1 and is updated based on the number of lots or recipes identified as material sources for the stability study. Identify the item, lot, and batches that serve as the basis for the stability study. Required.
• Storage Conditions displays the number of storage conditions required by the stability study. This field defaults from the number of storage conditions defined for the storage condition plan entered for the stability study.
  
• Enter Packages as the number of packaging configurations that you plan to use to build the stability study. A minimum of one packaging configuration is required. If you plan to study more than one packaging configuration, then enter the total number of packages. For example, if you plan to study an amber vial and clear glass vial closure system, enter 2 because these are two separate packaging configurations.
• Count displays the actual number of variants created.
  Dates
  
• Enter the Scheduled Start date for the stability study. This date cannot be changed after the stability study has a status of Stability Study Plan Approved. This scheduled start date is used to calculate the scheduled end date. Variants created by the application use the scheduled start date as the variant start date unless the material source has a yield date. Required.
• Scheduled End date is calculated by adding the longest time point identified across all the time intervals in the storage condition plan to the scheduled start date. You can only change this date until the stability study is approved. Required.
  
• Revised Start date displays a revision to the Scheduled Start date. You can only enter this field after the stability study has reached a status of Stability Study Plan Approved, but does not yet have a status of Approved for Launch. This revised start date is used to calculate the revised end date.
  
• Revised End date displays the revision to the scheduled end date based on the revised start date.
  
• Enter Actual Start date when the stability study is changed to a status of In Progress and defaults to the system date. The stability study can only reach this status when the:
  • Required number of initial samples for each material source have a disposition of Accepted or Accepted with Variance
  • Required number of variants are created
  • Stability study has a status of Approved for Launch
• Actual End date displays the date the stability study has a status of Completed.
  Recommendations
  
• Recommended Shelf Life displays the recommended shelf life for the item tested in the stability study. Enter this field when the stability study has a status of Completed. Enter a recommended shelf life in years, months, weeks, days, or hours.
  
• Recommended Storage Spec displays the ideal storage condition for the item tested in the stability study by entering the recommended storage specification and Version for the material. Enter this field when the stability study has a status of Completed.
  
• Save your work to create a stability study with the status of New.
  
• Assign material sources as described in the “Assigning Stability Study Material Sources” topic.
  
• Choose Change Status from the Actions menu to select appropriate statuses.
  
• Edit variants as described in the “Editing Variants for the Stability Study” topic.
  

To assign material sources to the stability study:

• Identify the item, lot, and batches to serve as the basis for the stability study as described in the “Planning a Stability Study” topic.
• Query the stability study to assign material sources.
• Click Material Source. Refer to the “Assigning Stability Study Material Sources” topic for additional information.

To edit variants for the stability study:

• Identify the unique combinations of the stability study storage conditions, the test interval plan, and the package.
• Query the stability study to edit variants.
• Click Variants. Refer to the “Editing Variants for the Stability Study” topic for additional information.

To edit text in the stability study:

• Choose Edit Text from the Actions menu. The Select Text Paragraph window displays.
• Make appropriate text changes.
• Save the window.

To mark the stability study for purge:

Choose Mark for Purge from the Actions menu. The record is marked for deletion.

To change the status of the stability study:

• Choose Change Status from the Actions menu.
• Select the desired status.
• Save the window.

To display the master item specification:

Choose View Master Item Specification from the Actions menu. The master item displays in the Specifications window.

To display the storage condition plan:

Choose View Storage Condition Plan from the Actions menu. The storage condition plan displays in the Storage Condition Plan window.

Etiketler: process quality, stability study