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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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# 3 Working with Campaigns

A Campaign describes a series of structured activities and processes required to produce a defined quantity of intermediate or final material and the Active Pharmaceutical Ingredient (API) used in a drug product.

There can be many campaigns in a project and you usually associate one campaign to one intermediate/API. You can also have one campaign associated with multiple intermediates/API.

You can have one or more campaigns associated with a product, while associating a campaign with a target material. Campaigns consist of many process steps and each process step in a campaign, tracks the making of several lots of materials within it. 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.

## 3.1 Creating a Campaign

While creating campaigns, you need to associate it to a Product and a Project. The Project must be in the In Development status and ensure that the Project-Product is in Active status.

Note: The system displays a warning to proceed if the Project is in Draft status. Also, ensure that the Project-Product is in Active status.

To create a new campaign:

1. Go to the Create New menu, select Processes > Campaign.

2. In the Characteristics sub-tab under General tab, enter the required information.

   Significant inputs:

   - Project Product - indicates the Product and Project ID for which you are creating this campaign. Click the Lookup icon, from the search results and select a product. The project ID associated with it is automatically filled up.

   - Target Material - select a Target Material ID for the Campaign.

   - Planned Campaign Site - The ID of the Site where you plan to execute this campaign.

   - Process Route - Defines the route a Process takes.

   - Stage of Work - A state in the work lifecycle of the campaign. For example: During Phase 3.

   - Environmental Regulation Summary (ERS). Select:

     At Campaign Level - if the regulations are applicable only at campaign level.

     At Process Step Level - if regulations are applicable only at process step level.

     N/A - If ERS is not applicable.

   - Initiating Order - The ID of the associated material order, if any.

   - Planned Quantity - The quantity of the material you plan to make.

3. Click Next.

4. In the Objectives sub-tab under the General tab, select Campaign Objective to identify the purpose of the campaign.

   Note: You can assign more than one objective to a campaign.

5. Click Finish to save the campaign.

### 3.1.1 Editing Campaign Details

You can edit a campaign provided it is in Draft, Approved, or In Progress status and not when it is in Submitted, Completed, Parked, Canceled, or Rejected status.

## 3.2 Campaign Tabs

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

- General: Lists details of the campaign.

  Characteristics: Lists the characteristics of the campaign

  Objectives: Identifies the purpose of the campaign.

- Notes and Attachments: Notes/attachments provide additional information.

- History: A detailed account of all events that occurs since its initiation.

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

  Workflows: Lists the workflows a campaign passes through.

  Changes: Records changes that a campaign undergoes from its initiation.

## 3.3 Changing Lifecycle Phases of a Campaign

A Campaign goes through the following phases:

- Draft: the state of a newly created campaign.

- Submitted: when the campaign is submitted for approval.

- Approved: when the campaign is approved.

- Parked: when the campaign is put on hold.

- In Progress: when the campaign is in use.

- Completed: when status of the campaign is manually set as complete.

- Rejected: when the campaign is rejected.

- Canceled: when the campaign is called off.

To change the lifecycle phase of a campaign:

1. Go to Processes > Campaign and run a search. From the search results select a campaign.

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

Note: For a Campaign to be Completed, all the control recipes associated with it must be in the Final status.

## 3.4 Alerts Associated with Campaign

Alerts inform you of actions you need to take.

Name | Type | Triggered when
--- | --- | ---
New Campaign Request Approval Alert | Non-Mandatory | You approve a new campaign request.
Cancel Campaign Request Alert | Mandatory | You cancel a new campaign request.
Campaign Modification Alert | Mandatory | You modify any one of the following campaign properties: Quantity Requested Requested Delivery Date

All the alert messages contain details such as Project ID, Project Name, Product, Campaign Name, Campaign Leader, Material Name Requested, Material Item ID Requested, Quantity Requested and Delivery Date Requested.