Product Lifecycle Management Agile Recipe Management for Pharmaceuticals - Process Management Guide Release 9.3.3 E39302-01 |
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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.
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:
Go to the Create New menu, select Processes > Campaign.
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.
Click Next.
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. |
Click Finish to save the campaign.
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.
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:
Go to Processes > Campaign and run a search. From the search results select a campaign.
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. |
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.