cGMP & WHO-GMP CERTIFIED INFRASTRUCTURE
Institutional Quality Assurance & Advanced Manufacturing Infrastructure
Precision engineering, cleanroom HVAC systems (Class 100,000), and automated high-speed formulation lines compliant with international pharmacopoeial standards.
WHO-GMP Certified (Good Manufacturing Practices)
ISO 9001:2015 (Quality Management System)
Schedule M Compliant (Regulatory Standard)
GLP Accredited Labs (Good Laboratory Practices)
In-House Analytical Laboratory & Quality Control
Every batch undergoes stringent physical, chemical, and microbiological evaluations prior to commercial QA release.
Chromatography & Spectroscopy
High-Performance Liquid Chromatography (HPLC) for assay and related substances.
UV-Visible Spectrophotometers for quantitative active ingredient verification.
Automated Dissolution Test Apparatus (multi-stage release profiles).
Stability & Mechanical Integrity
Walk-in and stand-alone Stability Chambers (Accelerated & Real-time testing: Zone IVb).
Friability testers, Digital Hardness testers, and Tap Density apparatus.
Disintegration testers and Karl Fischer moisture titrators.
Microbiological Assurance
Dedicated cleanroom microbiology zones with Class A laminar airflow hoods.
Total Viable Aerobic Count (TVAC) and pathogenetic bioburden screening.
Environmental monitoring protocols for particulate and microbial limits.
Cleanroom Environmental Controls & Critical Utilities
Engineered to prevent cross-contamination and maintain uncompromised sterile manufacturing conditions.
HVAC & Environmental Monitoring
- Air Handling Units (AHU): Dedicated, independent AHUs for individual processing zones to eliminate cross-contamination.
- Filtration Standard: Terminal HEPA filters providing 99.97% efficiency down to 0.3-micron particulate matter.
- Pressure Differentials: Positive air pressure cascades maintained and monitored via digital differential pressure gauges across Class 100,000 cleanrooms.
- Temperature & Humidity: Tight automated control (22°C ± 2°C, RH < 40%) optimized for moisture-sensitive formulations.
USP / BP Purified Water System
- Multi-Stage Generation: Pre-treatment, Two-stage Reverse Osmosis (RO), followed by Electrodeionization (EDI).
- Sanitization: Continuous ozonation and automated thermal sanitization loops.
- Distribution Loop: SS 316L electro-polished closed loop with continuous turbulent flow to prevent biofilm formation.
- Online Monitoring: Real-time conductivity, Total Organic Carbon (TOC), and regular endotoxin/microbial testing.
AUDIT-READY MANUFACTURING STANDARDS
Schedule an On-Site Technical Audit or Request Compliance Dossiers
We welcome qualified institutional partners, government tender agencies, and international distributors for comprehensive physical or remote QA audits. Complete CTD/ACTD dossier modules and validation packages available on request.
✓ Commercial evaluation & batch MOQs finalized prior to technical dossier release✓ Country-specific dossier compilation (ACTD / CTD / ASEAN modules)✓ Formal bilateral NDA executed prior to physical plant audit scheduling