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Product Lifecycle Management Agile Recipe Management for Pharmaceuticals - Process Management Guide Release 9.3.3 E39302-01 |
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# 5 Working with Control Recipes

A Control Recipe constitutes data that you collect and define to create a Work Request. It is associated with a process step and represents a chemical reaction that produces a product and by-product(s) or waste.

A Control Recipe is released as a template which in turn is used to create Work Requests.

## 5.1 Creating a Control Recipe

A control recipe is created keeping in mind the process steps that are defined to create a product and hence associated to a process step of a campaign or a project.

To create a control recipe:

1. Go to Create New menu, select Processes > Control Recipe.

   Note: The RMW application generates the Control Recipe ID automatically.

2. In the Preface tab, enter the required information.

   Significant inputs:

   - Control Recipe Belongs To - A control recipe can be associated to a process step of a campaign or it can be a part of a project. Select one of the below options.

   - Process Step of a Campaign - Search for process steps using the Lookup icon. From the results, select the process step to which you wish to associate the control recipe. Once you select the process step, the system automatically fills the campaign ID to which the process step belongs.

   - Project - Search for the Project and Recipe using the Lookup icon.

3. Click Next.

4. In the Attributes sub-tab of the General tab, enter the required information.

   Significant inputs:

   - Operating Mode - Select one of the modes it is going to be used for: Clinical or, Development and Not Applicable if either does not apply.

   - Scale Factor -The number used to scale Variable Quantities in recipes that are marked as scalable.

   - The Implementation Site, and the Planned Start and End Dates are automatically picked up from the Campaign or Project details. However, you have the option to change them.

5. Click Finish.

   Note: The information contained in the BOP, BOM, BOE, BOS and Output tabs is copied from the Recipe from which the Control Recipe is derived. To modify information in these tabs, click Next.

   Note: For complete details on these tabs, refer to Agile Recipe Management for Pharmaceuticals - Recipe Management Guide.

### 5.1.1 Editing a Control Recipe

You can edit a Control Recipe only when it is in the Draft status. Once a Control Recipe is in the Submitted status, you can edit only the Work Request associated with it. You cannot create a Control Recipe for a Canceled, Rejected, Parked or Completed Process Step.

## 5.2 Control Recipe Tabs

The tabs and sub-tabs on the Control Recipe - View Details page include:

1. General: Lists details of the Control Recipe

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 of the control recipe.

     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 control recipe.

   - Bill of Assay (BOA) - List of assays associated with the control recipe.

   - Bill of Standards (BOS) - List of applicable standards.

     Standards: List of standards applicable to the control recipe.

     Cautions: List of cautions used in the control recipe.

3. Outputs (or 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 occurs since the initiation of the Control Recipe.

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

Workflows:Lists the workflows a control recipe passes through.

Changes: Records changes that a control recipe undergoes from its initiation.

Print - Lists print details.

## 5.3 Requesting Inventory from Control Recipe

You can carry out the following material transactions from a control recipe:

- New Allocation Request

- New Dispense Request

  By Materials

  By Allocation Requests

- Material Pickup

- Material Consumption

- Material Return

All these transactions are valid for the material inventory.

To request inventory from a control recipe:

1. Go to Processes > Control Recipe. From the search results, select a control recipe.

2. Click More > Request Inventory.

   The Requests page appears with a list of materials associated with the Project.

3. To view the list of material associated with other levels of the process (Campaign, Process Step, Control Recipe and Work Request), select the desired option.

   The corresponding list of materials appear in a table.

4. Select the required materials and click the action button for material transactions (New Allocation Request, Pickup, etc).

   Note: For complete details on how to carry out Material Transactions, refer to Agile Recipe Management for Pharmaceuticals - Material Management Guide.

## 5.4 Reserving Equipment from Control Recipe

You can reserve equipment associated with a recipe from the control recipe. You can either reserve the entire Bill of Equipment (BOE) or individual equipment listed in the BOE. While reserving the equipment through BOE, RMW displays the estimated start and end date for the reservation duration by default. You can change the reservation dates at the BOE level or for individual equipment. Each of these reservations is for a single site.

To reserve equipment from a control recipe:

1. Go to Processes > Control Recipe and run a search. From the search results, select a control recipe.

2. Click More > Reserve Equipment. The Equipment Reservation: Add page with the Preface tab appears.

Significant inputs:

- The reservation purpose is automatically set to Process; however you have the option to select any one.

- If Equipment is already associated with the control recipe, these appear in the Equipment tab. You can add more equipment or delete the ones you do not require.

- In the Equipment tab, you are required to enter reservation period, the Start Date and End Date, for each equipment record.

Note: For complete details on how to carry out Equipment transactions, refer to Agile Recipe Management for Pharmaceuticals - Equipment Management Guide.

## 5.5 Creating Recipe Template from Control Recipe

You can use a control recipe as a recipe template; which can be at the General, Site or Master Level.

To create a recipe template from control recipe:

1. Go to Processes > Control Recipe and run a search. From the search results, select a control recipe.

2. Click More > Save as Recipe Template.

3. In the Preface tab, enter the Name for the new recipe template and select its Recipe Level.

4. Click Next.

5. In the General tab, use the Lookup icon and select

   - Company name, if you selected the Recipe Level as General.

   - Site of Execution, if you selected the Recipe Level as Site or Master.

6. Select Yes to duplicate all Notes and Attachments.

7. Click Finish.

## 5.6 Auditing Control Recipe

Once you create a control recipe, you can validate it for work request creation. You can validate the BOM, BOE and BOP specified in a control recipe and generate a consolidated list of errors, if any.

A warning message appears if:

- Equipment or materials used on the BOE/BOM are in Non-qualified status.

- Status of the equipment is Unavailable or Non-qualified.

- Variables used in the control recipe are not associated to any equipment or material. In addition, a dialog box appears, displaying variables, equipment and material, allowing you to match the variables with the correct equipment or material.

To audit a control recipe:

1. Go to Processes > Control Recipe and run a search. From the search results, select a recipe.

2. Click More > Audit Recipe.

In the Audit Recipe page, you see one of the following:

- A message indicating successful validation of the control recipe.

- An Exceptions Table listing the objects and the problems that resulted in unsuccessful validation.

## 5.7 Deleting Control Recipe

You can delete a control recipe if:

- a Work Request is not created for the control recipe.

- a Material Allocation Request is not made for the control recipe.

- an Equipment reservation is not made for the control recipe.

- it is not in the Completed state.

Note: You cannot delete a control recipe if it is in Approved, Canceled, Submitted or Completed status.

## 5.8 Changing Lifecycle Phases of a Control Recipe

The lifecycle phase of a Control Recipe can be changed manually or through a workflow. A control recipe has the following lifecycle phases:

- Draft: the state when you create the control recipe.

- Submitted: when you submit the control recipe for approval.

- Approved: when the control recipe is approved.

- In Progress: when the control recipe is in use.

- Rejected: when it is not approved for use.

- Canceled: when it is put out of use, even though approved.

- Completed: when all the associated work requests are in their final lifecycle phase.

To change the lifecycle phase of a control recipe:

1. Go to Processes > Control Recipe and run a search. From the search results, select a Control Recipe.

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