International quality standards to improve patient care
Effective quality management system implemented
QUALITY MANAGEMENT SYSTEMWe double check so you don’t have to Sutures India follows good manufacturing, laboratory and documentation practices that ensure consistent high-quality results. Each of our product is run through stringent quality checks so that surgeons and physicians can provide better patient treatment and care. At our state-of-the-art analytical facilities, we monitor and maintain a strict quality of our products, processes and services, consistently meeting Ph.Eur, USP and other national and international quality standards. We periodically review our quality management systems to keep it updated with any changes in the industry. Key functional areas Sutures India’s quality chain covers three key functional areas:
- Quality Control (QC) is responsible for all analyses undertaken at Sutures India. From analytical support during product development and validations to training Sutures India customers, QC is supported by a team of highly qualified professionals.
- Quality Assurance (QA) is responsible for implementing quality systems and releasing all manufactured products. They also develop and ensure harmonization of all systems throughout the organization. Audit responsibility including regulatory (national and international), customer, GMP and GLP is also under its purview.
- Regulatory Affairs ensures compliance with national and international regulatory requirements.
- ISO 9001
- ISO 13485
- COPP (Certificate of Pharmaceutical Product)
- 510k pre-market notification to US market
- 510k approval for selling in US
- Schedule – M GMP Certification for all the facilities as per D&C act, India
- Schedule – L GLP certificate for testing lab