Novartis is a Swiss pharmaceutical company with a significant presence in Slovenia, where its primary activities focus on the development, production and marketing of innovative medicines. The Slovenian branch supports the development of half of Novartis’ priority innovative medicines across all five of its technological platforms. At its locations in Ljubljana and Mengeš, the company employs over 3,500 people.
Challenges
Good Manufacturing Practices GMP (Good Manufacturing Practice) are a set of guidelines and standards that pharmaceutical companies must follow to ensure the quality, safety and efficacy of their medicines and pharmaceutical products. Ensuring GMP compliance is one of the key factors in the pharmaceutical industry, presenting several typical challenges.
Chief among these are the efficient transfer of formulations to production equipment, the collection, management and secure storage of process and reporting data, including integration with the Manufacturing Execution System (MES). Equally important is the rapid analysis of data and comparison with preset limits.
After evaluating international providers, Novartis selected Metronik’s MePIS RM and MePIS PDM, solutions, which are tailored to the specific needs of pharmaceutical manufacturing for managing and digitizing the lifecycle of production recipes and reports.
Solutions
Metronik’s MePIS RM is designed for central management, storage and automated transfer of production recipes for setting up production facilities. It allows users to manage the recipe lifecycle digitally, following a workflow that can be independently configured. It ensures that only recipes with all required approvals are available for production. The automated transfer of approved recipes to machines is handled by MePIS RM, or triggered from the MES system.
The MePIS PDM solution provides a validated central repository for data, events and alarms from the production process, along with the ability to generate production reports and conduct in-depth data analysis. Data in the central repository, organized according to the production model, serves as the source for reports and all further processing.
In addition to basic data viewing, the solution enables batch-to-batch comparisons, measurement comparisons with alarms in a unified view and an overview of the most frequent alarms on specific equipment or throughout the entire plant. It also supports periodic or automatic reporting of production data to the MES when anomalies are detected.
A key feature of the solution is the digital management of report lifecycles, which ensures that the system manages the status of each report and user rights concerning the reports.
Results
With the implementation of Metronik’s MePIS RM and MePIS PDM solutions, Novartis has achieved several key improvements. Automated data collection and storage have enabled paperless operations, reducing the need for manual data entry and decreasing the frequency of errors. Comprehensive data integrity helps improve compliance with regulatory requirements, while enhanced visibility of production data allows for faster response to anomalies and the identification of opportunities to optimize production processes.
The quality and efficiency of Metronik’s solutions have also led Novartis to adopt Metronik as a technology partner for digitalizing its manufacturing operations on an international scale.
Photography source: Novartis