Quality & Compliance
Rooted in quality. Driven by compliance. Trusted globally.
"Rooted in Quality. Driven by Compliance. Trusted Globally."
At Bharat Sterile, quality assurance is not an end-state — it is a continuous journey embedded in every SOP, every batch record, and every decision made on the manufacturing floor.
Quality Management System
A comprehensive ISO 9001:2015 and WHO-GMP aligned QMS covering document control, SOP management, change control, and continuous improvement frameworks.
CAPA Management
Robust Corrective and Preventive Action (CAPA) system with root cause analysis, effectiveness checks, and trend monitoring to prevent recurrence of quality issues.
Deviation & Change Control
Structured deviation investigation workflows and change control procedures ensuring every deviation is assessed, categorized, and resolved with full documentation.
Vendor Qualification
Rigorous approved vendor list (AVL) management with supplier audits, incoming material testing, and ongoing performance monitoring for all critical raw material suppliers.
Fully Equipped QC & Micro Labs
Our state-of-the-art quality control and microbiology laboratories are designed to support comprehensive testing requirements for all sterile APIs. Every instrument is calibrated, qualified, and maintained in accordance with pharmacopeial requirements.
Analytical Lab
- HPLC (Multiple systems)
- GC with headspace
- UV-Vis spectrophotometer
- IR/FTIR spectroscopy
- Karl Fischer titration
- Potentiometric titration
Microbiology Lab
- Sterility testing isolator
- LAL/BET endotoxin testing
- TYMC and TAMC testing
- Environmental monitoring
- Media growth promotion
- Microbial identification
Regulatory Audit & Inspection Protocols
Our facility maintains continuous audit readiness. We have structured internal audit programs and are experienced in hosting regulatory inspections from national and international authorities.
- WHO-GMP prequalification audit ready
- Customer audit hosting capability
- Quarterly internal GMP audits
- Mock inspection programs
- 21 CFR Part 11 compliant data systems
- Complete audit trail for all critical records
- Regulatory submission support (DMF, CEP)
- Post-inspection CAPA implementation
Stability & Data Integrity
Our stability program follows ICH Q1A guidelines with studies conducted at long-term (25°C/60%RH), accelerated (40°C/75%RH), and intermediate (30°C/65%RH) conditions.
- Calibrated stability chambers with continuous monitoring
- On-going and commitment stability studies
- Shelf-life assignment per ICH guidelines
- 21 CFR Part 11 compliant LIMS/data systems
- Electronic audit trails for all analytical data
- Data integrity training for all laboratory staff
Training & Workforce Compliance
Our people are our most important quality tool. We invest continuously in training and competency assessment to build a quality-conscious workforce.
- Induction training for all new employees
- Annual GMP refresher training
- Role-specific technical competency assessment
- Gowning qualification for cleanroom personnel
- Data integrity and ALCOA+ principles training
- Training effectiveness evaluation
Quality You Can Trust. Compliance You Can Verify.
Every API we manufacture is backed by complete documentation, third-party verification, and a team dedicated to maintaining the highest pharmaceutical standards.
Quality & Compliance Enquiry
Request GMP certificates, audit documentation, CoA samples, or schedule a quality call.