Our client, a prominent corporate entity from Saudi Arabia, has successfully acquired a Fill & Finish factory, which is a facility that specialises in packaging insulin for the local market. Our client's strategic vision includes upgrading the existing insulin filling line, establishing quality control laboratories, adding a second high-capacity filling line, and implementing an assembly line dedicated to insulin pen production. These initiatives have been designed meticulously to align with the rigorous compliance standards set forth in the European Union's cGMP guidelines and Annex 1.

Furthermore, the customer is committed to enhancing its Quality Management Systems (QMS) in strict adherence to EU cGMP guidelines. They will execute these critical re-engineering projects with unwavering dedication, supported by expert project management and meticulous procurement strategies.

Unizima is providing invaluable expertise to the client in this endeavour. Our services include a detailed re-engineering study of the existing insulin filling line, comprehensive engineering studies for the setup of cutting-edge quality control laboratories and new production lines, a thorough GMP compliance audit adhering to EU cGMP guidelines and Annex 1, complete with actionable recommendations for QMS enhancement, and proficient project and procurement management to ensure a successful transformation.