MePIS PDM and RM at Lendava packaging plant

Lek (Sandoz)

Logotipa Lek in Novartis

Lek is a member of the Sandoz group, an international pharmaceutical company and a pioneer in the field of biosimilar biological medicines. Sandoz is the second largest manufacturer of generic medicines in the world. Lek manufactures pharmaceutical and biotech active substances, pharmaceutical products and biological medicines.

The plant is the largest solid pharmaceutical packaging facility within Sandoz. It packages nearly seven billion tablets and capsules a year, with more than 4,000 finished product codes for patients in more than 120 countries.

CHALLENGE

For a pharmaceutical company, ensuring compliance with Good Manufacturing Practices (GMP) is crucial. Centralized management and integrity of production data, including reports from production equipment and production recipes for setting up equipment, are key factors in maintaining this compliance.

The main challenges in this area are:

  • Central management and storage of production data
  • Digitization of report lifecycle management
  • Automatic transfer of recipes to production devices and capture of process and report data
  • The ability to perform rapid analysis of process and report data
  • Automatic comparison of reporting data with predefined permitted values
  • Data exchange with the MES production management system

To effectively address the above challenges in the production of solid products, Lek has chosen to implement Metronik's MePIS PDM and MePIS RM solutions.

SOLUTION

Metronik's MePIS PDM platform provides validated central storage for data, events and alarms from the production process. It also offers the ability to generate production reports and perform in-depth data analyses. The central data repository, organized according to the production model, serves as the source for all further processing and reporting, which is accessible via a web application.

A key aspect of the solution is the digital management of the report lifecycle, meaning the system digitally manages the status of each report and user permissions. In addition to basic data viewing, the analysis part of the web application allows for batch-to-batch comparisons, measurement comparisons with alarms in a common overview, and an overview of the most common alarms on a specific piece of equipment or across the entire plant.

MePIS PDM also handles the reporting of production data to the MES, either periodically or automatically in the event of detected production deviations.

MePIS RM is designed for the central management and storage of production recipes for setting up production equipment. It allows the digital management of the recipe life cycle, according to a workflow that can be customized by the user. This ensures that only recipes with all required approvals are authorized for production. The system also manages the automatic transfer of approved recipes to the machines, which can also be triggered from the MES system.

RESULT

Metronik's MePIS PDM and MePIS RM solutions deliver several important benefits to Lek. Automated data capture and storage save time, reduce manual work and paper-based data recording, and consequently minimize errors and associated deviations. Improved integrity of production data and associated reports is an important prerequisite for meeting regulatory requirements. Better insight into production data enables quicker responses to non-compliance and serves as the basis for analysis and identifying opportunities for improving production processes.