CRAMS - QA & cGMP
Navin Fluorine is a custom research organization that supports customers in the early lifecycle of their product development. We are committed to providing customers with technically sound, economically viable, environmentally-friendly and safe processes on time, every time. This is achieved by:
- Understanding the requirements of the project and client.
- Providing rapid and sound feedback.
- Complying with requirements of Quality Management Systems as well as continually improving thier effectiveness.
- Maintaining safe working practices.
- Developing employees skills through effective training.
Quality Unit of Dewas site consist of :
1. Quality control laboratory
2. Microbiology laboratory
3. Quality Assurance department
4. Regulatory affairs
Quality control :
NFIL has established quality control laboratory. Sophisticated analytical instruments like HPLC( UV and PDA detector) , UV spectrophotometer, FTIR. Head space Gas chromatograph, Melting point apparatus, KF Titrator etc are installed and qualified. Stability chambers of adequate size are installed and qualified to perform stability studies of APIs and API intermediates as per ICH guideline. Analytical software comply with US regulation 21 CFR part 11. Quality control department is responsible for all analyses undertaken at NFIL, Dewas
Microbiology Laboratory:
Equipment like biosafety cabinet, autoclave, dual chamber incubators, colony counter, ovens etc are housed and qualified in microbiology laboratory. Our laboratory is fully equipped for microbiological testing of products, air, water, surface etc.
Quality assurance :
Quality assurance is responsible for implementation of quality system at manufacturing site. It is also responsible for all regulatory and customer audits. Our quality assurance is driven by a strict adherence to Good Manufacturing Practices (GMP) standards.
Regulatory affairs :
Regulatory Affairs ensures compliance with national and international regulatory requirements. NFIL has capability to prepare and file Drug Master File, Certificate of Suitability, Technical dossiers for APIs and API intermediates in regulated and semi-regulated markets.


