At Astra Generics, quality is not just a compliance requirement—it is the foundation of our operations. We follow stringent global quality management systems to ensure that every product manufactured and supplied meets the highest levels of safety, efficacy, and consistency.
Our regulatory philosophy is to remain proactively compliant with international guidelines while ensuring smooth product registration and timely market access for our partners worldwide.
GMP-Compliant Facilities
Manufacturing units designed and operated in line with WHO-GMP, cGMP, and ISO 9001 standards.
End-to-End Quality Oversight
Raw material qualification and vendor audits.
In-process monitoring and real-time controls.
Batch release only after rigorous QC and QA review.
Analytical Excellence
Advanced laboratories for method validation, stability testing, and impurity profiling.
Stability chambers conforming to ICH Q1A guidelines.
100% traceability and documentation.
Global Regulatory Readiness
Our products and dossiers are aligned with requirements of USFDA, EMA, MHRA, TGA, WHO, and other global agencies.
Comprehensive Documentation
Common Technical Dossiers (CTD / eCTD format).
Drug Master Files (DMFs) for APIs.
ANDA/MAA preparation support for partners.
Audit Preparedness
Regular internal and third-party audits.
Mock inspections simulating global regulatory standards.
Corrective and preventive action (CAPA) framework.
