Quality Certifications & Accreditations
Accreditation overview and statutory compliance commitments.
Accreditation Plaques & Documents
ISO 9001-2015 CERTIFICATE
International Organization for Standardization (ISO 9001:2015)
View Document4-Stage Formulation Quality Lifecycle
Analytical testing standards, batch stability testing, and validation documentation.
Raw Material Testing
All Active Pharmaceutical Ingredients (APIs) and excipients undergo strict physical, chemical, and microbiological assay before batch formulation.
In-Process Quality Controls
Continuous monitoring of tablet hardness, friability, disintegration times, suspension pH, and fill volume across all automated lines.
Finished Product Validation
Finished packs undergo dissolution testing, microbial limit validation, and HPLC assay checks to ensure exact therapeutic potency.
Stability Chamber Studies
Real-time and accelerated stability testing under Zone IVb climatic conditions to guarantee 24 to 36 months product stability.
Frequently Asked Questions
Are Sygnus Biotech facilities compliant with WHO-GMP and Schedule M?
Yes. Our pharmaceutical manufacturing infrastructure complies with World Health Organization Good Manufacturing Practices (WHO-GMP) and revised Schedule M guidelines, featuring HEPA-filtered cleanrooms, classified HVAC systems, and purified water generation.
Is a Certificate of Analysis (COA) provided with trade consignments?
Yes. Every batch dispatched to distributors, stockists, and hospital institutions is accompanied by an official Certificate of Analysis (COA) certifying its chemical assay and microbiological safety.
Can institutional clients and tenders audit your facilities?
Yes. We welcome technical audit teams from government health agencies, export partners, and institutional buyers by prior appointment.