Lek (member of the
Sandoz – Novartis Group)
Lek is member of the Sandoz group, the generic division of Novartis, a pioneer in the field of biosimilar biological medicines and second largest manufacturer of generic medicines in the world. Lek manufactures pharmaceutical and biotech active substances, pharmaceutical products and biological medicines
Production recipe management through entire life cycle is a crucial element of data integrity. Since several people are involved in recipe approval, sitting in different locations, it is mandatory that recipe management is executed through web based system which doesn’t require any software installation on client computers.
The MePIS RM represents a universal solution for recipe management for life science industries. In Lek it is connected to 60 manufacturing machines from different vendors at three production sites, namely solids, sterile and biotech production. The system takes care of the storage and versioning of the recipes. A single recipe can be downloaded to several devices of the same type. Users may download recipes comfortably in their offices through web-based graphical interface. The system follows GMP recommendations, and is implemented according to GAMP 5 and is compliant with 21 CFR Part 11.
By using the MePIS RM the user can better manage production recipes, regulatory compliance and data integrity are improved, while at the same time the changeovers between the production of different products have been accelerated.