Quality & Compliance
Quality is the cornerstone of everything we do at SterisCare Pharma. Our quality management system is built on the principles of WHO Good Manufacturing Practices (GMP), ICH guidelines, and ISO 9001:2015.
Certifications
- WHO-GMP Certified — Recertified FY 2025-26 with zero critical deviations
- ISO 9001:2015 — Quality Management System
- Schedule M Compliant — Indian GMP standards
- CDSCO Approved — All production lines
Quality Control Laboratory
Our QC laboratory is equipped with HPLC, GC, UV-Vis spectrophotometers, dissolution testers, and a stability chamber capable of ICH Zone IVb conditions. All analytical methods are validated to USP/BP standards.
Continuous Improvement
We run a structured CAPA (Corrective and Preventive Action) programme with a 94% closure rate within 30 days — well above the industry benchmark of 75%.
| Metric | FY 2025-26 | Industry Benchmark |
|---|---|---|
| Batch Rejection Rate | 0.41% | 0.8% |
| OOS Investigations | 12 | — |
| CAPA Closure (30d) | 94% | 75% |
| Customer Complaints / M Units | 2.3 | — |