Validations: Serialization Change Control
Impact Assessment Trees: What to Verify vs Re-Validate Introduction to Impact Assessment in Serialization In the pharmaceutical industry, particularly within the domains of serialization and aggregation, the importance of rigorous validation processes cannot be overstated. Impact assessments serve as a critical component of these validation efforts, ensuring that systems and processes conform to regulatory standards such as the FDA, EMA,…
Test Packs for Changes: Regression, Interfaces, and Lines In the modern pharmaceutical industry, the need for robust serialization and aggregation systems has become paramount. Ensuring compliance with regulations such as the Drug Supply Chain Security Act (DSCSA) in the US and the EU Falsified Medicines Directive (FMD) is crucial to maintaining not only legal compliance but also data integrity and…
Master Data Changes: GTIN, GLN, SSCC, and Who Approves Master Data Changes: GTIN, GLN, SSCC, and Who Approves Introduction to Master Data Management in Serialization The implementation of serialization within the pharmaceutical supply chain requires rigorous management of master data, which encompasses Global Trade Item Numbers (GTIN), Global Location Numbers (GLN), and Serial Shipping Container Codes (SSCC). These elements ensure…
Partner On/Off-Boarding: Change Controls That Work In the pharmaceutical sector, ensuring robust serialization and aggregation processes is paramount for compliance with regulations such as the US Drug Supply Chain Security Act (DSCSA) and European Falsified Medicines Directive (FMD). A meticulous approach to change control during the on-boarding and off-boarding of partners serves as a cornerstone of maintaining data integrity and…
EPCIS Upgrades: 1.2→2.0—Evidence Expectations The evolution of the Electronic Product Code Information Services (EPCIS) from version 1.2 to 2.0 presents significant implications for the pharmaceutical industry, particularly concerning serialization and data integrity. As regulatory bodies such as the FDA, EMA, and MHRA intensify their focus on compliance with data integrity standards, understanding the latest updates and expectations associated with EPCIS…