4 Working with Process Steps

A Process Step defines the processes involved in creating the final drug product. Each process step can contain several control recipes; and each control recipe tracks the making of a single lot or several lot of material within it. A Process Step need not always refer to making material; it can represent other activities such as cleaning, setting up, or dismantling equipment, standards or cautions it is associated with, etc.

A Process Step specifies the number of control recipes and also the planned quantity of the target material. The planned target quantity per control recipe is also populated within the process step.

4.1 Creating a Process Step

Since a Process Step defines the processes involved in creating the final drug product, you can add a Process Step to a Campaign. Each process step in a campaign, tracks the making of several lots of material within it. A process step or a recipe need not always make materials; it can represent other activities in the campaign such as cleaning, or equipment setup/dismantling.

A Process Step contains several control recipes; each control recipe making a single lot or batch.

To create a process step:

1. Go to Create New menu > Processes > Process Step. A New Process Step page appears.

2. In the Recipe tab, use the Lookup icon and associate a recipe to the Process Step. An existing recipe is associated with a Process Step. The Name and Version fields are automatically populated with the data from the recipe you selected.

3. Select a campaign using the Lookup icon.

4. Click Next.

5. In the Details sub-tab under the Process Step Details tab, all the fields are updated automatically with data from the recipe you selected.

6. Click Next.

   Bill Of Processes (BOP) > Instructions

   1. In the Instructions sub-tab under BOP tab, select the recipe record and click Edit SFC to create a sequential flow chart of process. The edit SFC button helps you to add recipe actions and recipe elements.

   2. In the right pane of SFC Editor, click on the Start Is Complete object and click Delete.

   3. Click New > Recipe Element from Template. You can also right-click in the right pane of the editor and select the same option from the menu.

   4. Select a Recipe Element Template and click OK.

   5. Click anywhere in the right pane to add the recipe element object. For complete details on how to use SFC Editor, see Working with SFC Editor in the Recipe & Material Workspace Recipe Management Guide.

   6. When you add a recipe element template, the recipe action templates associated with it are added automatically. If you wish to add more recipe action templates, click New > Recipe Action Template and select the desired templates.

   7. Click OK.

   8. In the Instructions tab, a table listing the recipe and associated recipe elements and recipe actions appear. The instructions that you entered in the recipe action template appear in the right column.

   9. To edit a recipe element template or a recipe action template, select the desired record and click Edit.

   10. To save the recipe BOP as a template for future use click Save As Template.

7. Click Next.

   The Parameter tab displays a list of parameters associated with the Recipe with details. To edit a parameter, select the desired record and click Edit.

8. Click Next.

   Bill of Material (BOM)

   In the Materials sub-tab under the BOM tab, a list of material variables appears. You can resolve the unresolved variables, view sample information of the material to which a variable is resolved. You can add, delete, and edit the variables.

   1. For each material, enter the Planned Quantity to Consume and the Display Order, in which the items must appear in the recipe list.

   2. Select a material variable and click View Sample Information to view the information of a material sample. The Sample Information page appears, displaying the Lot ID and other details from which the selected material was sampled.

   3. To add a new material directly to the BOM, click More > Add Material.

9. Click Next.

   In the Consumables sub-tab under BOM tab, the list of material variables of the type Consumable appears. You can resolve the unresolved variables, and add, delete and edit the variables.

   1. To add a new consumable material directly to the Consumable sub-tab under1 BOM tab, click More > Add Material.

   2. For each material of the type Consumable, enter the Planned Quantity to Consume.

   
   

   Note: The Unit of Measure of the material is Unit.

   
   

10. Click Next.

    The Specification Plans sub-tab of the BOM tab lists specification plans associated with the recipe. You can add new specification plans or delete the inapplicable plans.

11. Click Next.

    The Equipment sub-tab lists equipment variables. You can resolve the unresolved variables, view disposition of equipment, and also add, delete or edit equipment variables.

    Bill of Equipment (BOE)

    1. To add new equipment, click More> Add Equipment.

    2. In the Search Equipment Page, select the Recipe Action associated with it.

    3. Enter a value in any field and run a search. Select Equipment from the search results and click OK.

    4. To resolve an unresolved equipment variable, select a variable record and click Resolve Variable.

    5. To view the disposition of equipment, select an equipment variable record and click View Equipment Disposition. The Equipment Disposition page displays the equipment name, its availability status, etc. It also contains the OK, Reservations and View Last CleaningActivity buttons.

    6. Click OK to return to the BOE page.

    7. Click Reservations to see the reservations made on the equipment. You can also create new reservations/ edit reservations from this page.

    8. Click View Last Cleaning Activity to see the last cleaning activity performed on the equipment.

12. Click Next.

    Output

    The Output tab, lists output material variables defined in the Instructions tab of recipe action templates. You can edit these variables, add new material variables and resolve the unresolved variables.

    1. To add material, click More > Add Material.

    2. In the Search Material page, select the Recipe Action associated with it.

    3. Enter a value in any field and run a search. Select a material from the search results and click OK.

    4. Enter Output Quantity. Select the appropriate UOM from the drop-down list.

    5. Select the Type of the output.

    6. To resolve an unresolved output variable, select a variable record and click Resolve Variable.

13. Click Next.

    Bill of Standards (BOS)

    The BOS tab lists standards defined in the instructions entered in recipe action templates. You can edit these standards add new standard variables and resolve the unresolved variables.

    To resolve an unresolved variable, select a variable record and click Resolve Variable.

14. Click Next.

    The Cautions tab displays the caution type standards associated with resolved materials and equipment.

15. Click Finish.

    A message appears confirming the creation of the Process Step.

4.1.1 Editing a Process Step

You can edit a Process Step only when it is in the Draft status. While editing a Process Step, you can edit the Recipe Action associated with it and add Material, Equipment or Standards directly to the BOM, BOE or BOS without creating a variable.

4.2 Process Step Tabs

A The tabs and sub-tabs on the Process Step View Details page includes:

1. General: Lists details of the Process Step.

2. Bills of ...: Displays the BOP, BOM, BOE, BOA and BOS sub-tabs.

   • Bill Of Process (BOP): A collection of approved Unit Operations.

     Instructions: Lists recipe and associated recipe elements and recipe actions. Includes a view of the Sequential Flow Chart (SFC). Parameters: Displays the parameters values that were entered and the results.

   • Bill Of Materials (BOM): A list of materials, which are required to produce the target material.

     Material: List of material variables.

     Consumables: List of consumable material variables.

     Specification Plans: List of specification plans associated with the recipe.

   • Bill Of Equipment (BOE): List of equipment required / used in the process step.

   • Bill of Assay (BOA): List of assays associated with the process step.

   • Bill of Standards (BOS): List of applicable standards.

     Standards: List of standards applicable to the process step.

     Cautions: List of cautions used in the process step.

3. Output: List of final material you wish to produce.

4. Notes and Attachments: Notes/attachments providing additional information.

5. History: A detailed account of all events that occur since the initiation of a Process.

   Status Transition: Lists all the transitions the object undergoes from its initiation.

   Workflows: Lists the statuses of a Process workflow.

   Changes: Records changes that a process step undergoes from its initiation.

   Print: Lists print details.

4.3 Changing Lifecycle Phases of a Process Step

A Process Step goes through the following phases:

• Draft: the state of a newly created process step.

• Submitted: when the process step is submitted for approval.

• In Progress: when the process step is in use.

• Parked: when process step is put on hold.

• Approved: when the process step is approved.

• Completed: when status of the process step is manually set as complete.

• Canceled: when the process is called off.

To change the lifecycle phase of a process step:

1. Go to Processes > Process step and run a search. From the search results select a process step.

2. Click Change > Lifecycle Phase and select the applicable phase.

4.4 Validating the Process Step for Control Recipe Creation

Validation of a process step helps in checking if all variables in the BOP have been resolved.

To validate a process step for creation of a control recipe:

1. Run a search and select a process step.

2. Click More > Validate for Control Recipe Creation.

   The Validate for Control Recipe Creation page appears, displaying the following:

   • List of exceptions, if any

   • Problems encountered during creation with error messages. For example: Containers not in Evaluated status or equipment not in Available status.

   • The problems describing the reason for exception.

3. Click OK.

4.5 Creating Control Recipe from a Process Step

You can create a control recipe from an approved process step of an approved campaign.

To create a control recipe from a process step:

1. Go to Processes > Process Step and run a search. From the search results, select a process step.

2. Click More > Create Control Recipe. The Control Recipe- New page appears.

   The application automatically selects Process Step of Campaign option for Control Recipe Belongs To, and populates the Process Step fields.

3. To create a control recipe, see Creating a Control Recipe.

4.6 Deleting a Process Step

You can delete a Process Step only when it is in the Draft, Canceled or Rejected status and not when it is in the Approved status.