Labeling - Creating a PRL/FPL

This video provides a detailed, step-by-step walkthrough of the pharmaceutical labeling process, specifically focusing on the creation and management of the Final Print Label (FPL) or Pre-Restricted Label (PRL) within a regulated document management system, strongly implied to be Veeva Vault. The main purpose is to guide users—likely regulatory affairs or labeling specialists—on transitioning an approved Master Label (ML) into the final document required by the supply chain for graphic creation and printing. The process emphasizes maintaining regulatory integrity by ensuring proper version control, document classification, and workflow management before the label is released for production.

The workflow begins immediately after a regulatory action has been approved, resulting in an approved Master Label. The first critical step involves creating a complete copy of the approved ML. This is done to initiate a new versioning cycle, acknowledging that the PRL/FPL is a distinct document classification separate from the ML, even though it is derived from it. Following the copy creation, the document must be formally reclassified within the system as a Print Restricted Label (PRL) or Final Print Label (FPL). Once classified, the document is checked out for editing, where specific commercial or logistical modifications are made. These modifications typically include updating the alternate brand name, adjusting storage and disposal instructions, removing regulatory bracketed text, and adding specific use restrictions that apply to the final market product.

A crucial regulatory and operational step involves linking the newly created PRL/FPL back to its originating Master Label. This relationship management ensures a clear audit trail and traceability between the final printed material and the centrally approved regulatory document. The video highlights the importance of documenting specific PRL/FPL instructions within the system, which serves as institutional knowledge for future labeling iterations. Once all edits are complete and the document is checked back in, the label is ready to enter the release workflow. Depending on internal procedures, the label can be sent directly to release or routed through an optional review cycle, potentially involving state registration managers. The final step involves initiating a system workflow to send the released label to the supply chain department, which triggers a notification and task creation for the supply chain manager to proceed with graphic label creation and subsequent state registration review.

Key Takeaways: • Mandatory Version Reset for FPL/PRL: When transitioning from an approved Master Label (ML) to a Final Print Label (FPL) or Pre-Restricted Label (PRL), users must create a complete copy of the ML to initiate a new, independent versioning cycle. This separation is crucial because the FPL/PRL is considered a distinct document classification, even though its content is derived from the ML. • Document Reclassification is Essential: After copying the ML, the new document must be explicitly reclassified within the document management system (e.g., Veeva Vault) as a PRL or FPL. Proper classification ensures the document follows the correct lifecycle and regulatory workflow specific to print materials. • Specific Editing Scope for Print Labels: Edits made to the PRL/FPL are focused on commercial and logistical details necessary for printing, such as changing to the alternate brand name, updating storage and disposal information, and removing temporary regulatory bracketed text, while ensuring the core regulatory content remains compliant with the ML. • Traceability via Document Relationships: It is a best practice and regulatory requirement to formally link the new PRL/FPL back to its approved Master Label (ML) using the system’s document relationship features. This linkage provides an essential audit trail for regulatory compliance and efficient document retrieval. • System-Driven Workflow Initiation: The process culminates in initiating a workflow (e.g., "Send to Supply Chain"), which automatically generates a notification and a task for the designated recipient (the supply chain manager), ensuring accountability and process adherence. • Importance of Documenting Instructions: Users should utilize the dedicated section within the document management system to record specific instructions for the PRL/FPL. This documentation serves as a critical knowledge base for future label iterations, preventing the need to rely on external notes or tribal knowledge. • Optional Review Cycle: Before final release, the label can be routed through an optional review process, often involving stakeholders like the State Registration Manager, to ensure all regional or specific requirements are met prior to printing. • Supply Chain Responsibility: Once the PRL/FPL is released and sent to the supply chain, their task involves uploading the final state-registered graphic label back into the system and initiating a subsequent review cycle for the final registered material.

Tools/Resources Mentioned:

• Veeva Vault (Implied): The entire process, including document classification, versioning, check-in/check-out, relationships, and workflow management, is conducted within a regulated document management platform like Veeva Vault.
• Microsoft Word (or equivalent): Used for checking out and editing the document content, with the ability to view markups via the system’s rendition settings.

Key Concepts:

• Master Label (ML): The primary, regulatory-approved document containing all necessary information for a product, serving as the source for all subsequent print labels.
• Final Print Label (FPL) / Pre-Restricted Label (PRL): The version of the label derived from the ML that contains the specific commercial and logistical details required for printing and distribution. This is the document sent to the supply chain.
• Versioning Cycle: The system used to track changes to a document. Creating a copy of the ML restarts this cycle for the FPL/PRL, ensuring independent tracking.
• Document Classification: Assigning a specific type (e.g., ML, FPL, PRL) to a document within the system, which dictates its lifecycle, permissions, and workflow path.
• Document Relationships: A feature within the document management system that formally links related documents (e.g., linking the FPL back to the ML) for traceability and audit purposes.