global standardization
As a Contract Development and Manufacturing Organization (CDMO) serving numerous clients, business units, and varied operational approaches, the project faced a significant lack of standardization across the organization.
With numerous sites, customers, and processes, standardization can quickly escalate into scope creep and a never-ending process.
To mitigate this, the project developed a blueprint for at first a smaller pilot site, incorporating all complexities and build a bottom-up solution. After this successful implementation was achieved at the pilot site, the project deployed the blueprint to all Cell and Gene sites, ensuring a top-down approach to standardization.
Lonza's Enterprise Resource Planning system SAP, is considered a Good Manufacturing Practice (GMP)-relevant system.
To streamline implementation and validation, the global IT team did validate requirements at a global scale, leveraging a pre-configured system.
However at the business unit or site level, the specific processes require to combine common elements into a site-specific architecture, which thenm should be treated as a customized system.
To comply with GAMP5 guidelines, the project had to conduct extensive computer system validation (CSV) testing tailored to the specific process build.
The Business Process Architecture is outlined in a comprehensive Blueprint document and a series of Standard Operating Procedures (SOPs), which serve as the guiding principles for the deployment of Lonza's processes across existing Cell and Gene Therapy sites.
The blueprint is deployed in new acquisitions as well, ensuring consistency and efficiency throughout the organization.
The process is being applied on different production sites with over 1000 users.