In what for some may be a relatively chaotic run-up to meeting California’s 2015 serialization regulation, it is critical for serialization project managers to assure implementation falls within the constraints of, and the resulting serialization process is integrated within, the existing-compliant quality systems, including those that govern Validation, Controlled Documentation, and Labeling.
Establishing robust serialization process capability will require new or modified equipment and software for material handling, printing, verification, and serial number control, e.g., generation, commissioning/decommissioning, aggregation and storage, and may require modification to classified manufacturing areas. In some cases, as may be required by the Site Validation Master Plan, the scope of the project will warrant establishment of a Validation Project Plan. Successful implementation of the serialization process will require documentation of user, functional and design specifications, with subsequent development and execution of installation, operational and performance qualification protocols.
The addition of serialization capability will drive changes to controlled documentation affecting multiple functional areas. Updates may be required to SOP’s covering preventive maintenance, line setup, startup challenges, line operation, end-of-lot reconciliation, and QA sampling/testing, some of which may drive changes to training modules. Master Batch Records should be changed as needed to reflect the materials, equipment and process steps associated with serialization.
Changes will be required to approved labeling on either the primary or secondary package, and in some situations, the package size may need to increase to provide the addition space needed for serialized information. Determining and implementing the required changes will necessitate close collaboration among equipment engineers, packaging engineers, printed-material suppliers, regulatory specialists, materials managers and quality assurance professionals.
Emphasizing serialization project alignment and integration with quality systems will help generate the broad stakeholder participation required for technical and organizational success and set the stage for additional leveraging of serialization capability across the business.