Defining Inputs for Manufacturing a Lot

You can define input parameters for an activity used to manufacture a new lot of a material.

Before you begin: Either request a new lot of an existing material or define a new material and request manufacture of a lot.
See Also
Requesting Materials and Lots
Products, Materials, Batches, and Lots
Introductory Concepts
  1. Select the Materials tab of a study with a new lot request.
  2. Click Select an activity.

    Important: You cannot request approval for a study where any of the requested lots have no manufacture activity selected.

  3. From the list, select the activity that describes the procedure for producing the requested material and click Add.

    You can only select one activity. Activities selected in the Activities tab cannot be added for the manufacture of requested materials.

    Tip: Use the 6WTags to reduce the number of items in the list. For more information, see About Predefined Queries.

    If the Domain Standard is specified as GMP, you can only select approved activities for the study. For more information, see Creating a Study.

  4. Click OK.
    This displays the activity name in the Activity column and lists the inputs in the Parameters table.
  5. Optional: Specify the Requested Amount of the material lot to generate, including the units.

    If you do not enter a Requested Amount, the value is automatically defined to match the calculated total Required Amount.

    Tip: Click to open the Summary Amount view, for each material this reports the amount required for each storage condition, test, and time point, as well as the total amount. For more information, see Summary Amount.

  6. Optional: If you choose Each as the unit for the lot, define the quantity and units for the Eaches.
    If tests, storage conditions, and time points already exist for the study, the required amounts update to display with Each units, taking into account the Each quantity defined.
  7. Optional: If you are requesting manufacture of more than one material or using more than one manufacture activity, select at least one Custom Filter for the Parameters table.
  8. In the Parameters table, for each input specify the value to use when manufacturing each material using each activity.

    Beginning to edit a parameter value provides an indication of its input data type and valid values. If you enter an invalid value, this displays a warning message.

    Tips:
    • If you have many materials or a short browser window, the Parameters table collapses below the Materials list. In this case, click Edit Input Parameters to expand the Parameters table. To return to displaying the Materials list, click Edit Materials.
    • You cannot change the units for quantity parameters.

  9. Optional: Change the Custom Filter settings for the Parameters table and specify inputs for all material manufacture activities.
  10. If the study design is not yet defined, proceed to define storage conditions and design tests.

    For more information, see Defining Storage Conditions and Designing Tests.

  11. To save your changes to the study, click Apply.

This defines the input values and requested amounts of the material lots to manufacture. When you activate the study, the tasks created include the specified values.