Validation Exercise for Upgrade of the Systech’s Serialization Program v8.01 at a Packaging Line

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. Eight protocols were executed, documents were updated and reports were generated to assure the system was satisfactorily upgraded. From 3721 steps executed, 96.60% passed right and 131 steps failed generating 59 discrepancies and 7 re-test exercises related to protocol errors, error in reference documents and equipment failure. It was concluded that main offenders 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 upgrades. Key Terms - Packaging, Serialization, Upgrade, Validation.