Kemwell team has extensive audit handling experience and capabilities. The facilities are audited by reputed global multinational clients, European QPs, former USFDA inspectors and regulatory agencies. A USFDA Pre-Approval Inspection (PAI) for a BLA filing is expected by 2020.
Kemwell takes a multipronged approach to reinforce these systems:
- Delivering the highest quality products and services on time has been a part of Kemwell’s culture and commitment.
- Emphasizing on creating a “Quality at Source” culture from the shop floor to the boardroom with our “Champions Initiative”
- Creating transparent quality metrics and review systems
- Building compliance teams and quality review teams to maintain high compliance levels and monitor for continuous improvement
- Making employees aware and providing training and discussions of audit findings from global health authorities that are public knowledge
We are committed to the health and safety of our employees and we strive to minimize our impact on the environment. We have:
- Developed comprehensive EHS policies and guidelines with appropriate training for all employees
- Implemented EHS according to regulatory requirements with systemic monitoring
- Our facilities are audited and approved by the global EHS teams of our customers