RNPC provides a complete portfolio of services related to API – Product manufacturing & Quality services, that includes :
Solutions for API Manufacturing, like –
1.Qualification of Equipment and Systems
- Technology transfer Process support & Improvement
- Validations
- Water system
- Utility system set up
2.Quality Management Systems
- All document related support as per regulatory requirements of FDA, WHO, USFDA, MHRA, EDQM, EU etc.
- Gap Analysis of existing systems
- Support in compliance for regulatory audit findings
- Risk Assessment as per regulatory guidelines
- Recommendations and corrective & Preventive Actions based on assessment Recommendations and corrective & Preventive Actions based on assessment
- Compliance support for the observations noted during regulatory audits.
- GMP audits and recommendations
- New SOP preparations and review of existing SOP’s
3.Turn key Projects for API
4.Product Manufacturing Technology