Our quality is more than a promise; it’s a genuine performance.
Quality Systems
Quality Control
- Divi’s Quality Control testing and validation labs are equipped with state-of-the-art analytical instruments and testing facilities.
- More than 2,000 highly trained professionals in our Quality Control team conduct routine analyses of raw materials, in-process samples, intermediates, finished APIs, water, packaging materials, and end-of-run cleaning samples. Environmental monitoring of bioburden levels in API pharma areas is also performed to ensure compliance and safety.
- Quality Control labs are equipped with a comprehensive range of advanced UPLCs, HPLCs, GCs, particle size analyzers, XRPD, LC-MS, GC-MS, stability chambers, moisture analyzers, and microbiology equipment. All testing is conducted in-house, with no reliance on outsourcing.
Quality Assurance
- Quality Assurance and Regulatory Affairs teams of more than 500 professionals, continuously monitor and maintain various aspects of the Quality Management System (QMS).
- Divi’s is committed to upholding the highest quality standards in cGMP manufacturing through periodic reviews and proactive improvement of the QMS. Robust quality systems at Divi’s ensure consistent product integrity.
- Our manufacturing units (Unit 1 and Unit 2) have successfully undergone 42 cGMP audits by global regulatory authorities and over 2,000 quality audits conducted by our valued customers.