Validation Exercise for a Vial Secondary Serialization Packaging Line Upgrade

Abstract

Serialization has been the focus during the past years due to the new worldwide regulation related to the track and trace of pharmaceutical products. Companies dedicated all their efforts incorporating new technology to their actual packaging lines. Some has to update their serialization systems versions to improve their process. For this update a complete validation strategy and exercise was developed: from Commissioning and Qualification to Packaging Line Integration. Ten (10) protocols were executed, documents were updated and reports were generated to assure the system was satisfactorily upgraded. From 202 steps executed, 73.80% passed and 53 steps failed generating discrepancies and re-test exercises related to protocol errors, error in reference documents and equipment failures. It was concluded that main culprits were lack of information, human error, wrong information found on vendor’s documents and configuration errors. A closing meeting was held to identify lessons learned and improvement’s opportunities for upcoming packaging line upgrades. Key Terms - Packaging, Serialization, Upgrade, Validation.