Quality & Compliance
We offer services to maintain acceptable status of GMP as per prevailing regulations worldwide in below area.
- GMP audit preparation for USFDA, MHRA, PIC/S, ANVISA, WHO-GMP etc
- GMP gap assessment and remediation of Quality system, Manufacturing, laboratory and Engineering
- Development of document management system.
- Development of entire Quality and GMP System
- Perform Equipment, Utility and Facility Qualification.
- Perform process, analytical and cleaning validation
- Perform risk assessment of the system and facility
- Performing vendor audits of API, Intermediates, Excepients, Packaging material
- Impart GMP trainings on various topics to
- Workmen
- Officers
- Advance training modules For Manager and Above.