The 6 Pillars of Our Quality Management System
Click an orbital pillar node to inspect governance standards, QA validation, and analytical protocols.
Analytical Precision
Validated assay methods with HPLC, UV spectrophotometry, and Karl Fischer titrators ensuring 100% active constituent accuracy.
Compliance Objectives
- Strict alignment with current Good Manufacturing Practices (cGMP).
- Documented batch records and multi-tier quality sign-offs.
- Periodic internal and third-party audit verification.
Our Quality Covenant
“We at Sygnus Biotech commit ourselves to the continual improvement of the Quality of our products, processes, and systems in order to exceed the clinical and therapeutic expectations of healthcare practitioners and patients across India.”
From Active API to Patient Safety: 6-Stage Lifecycle
Strict stage-gate controls preventing contaminated or sub-potent materials from advancing into downstream formulation.
Raw Material Qualification
100% chemical assay, identity testing, and microbial limit testing on all APIs and excipients prior to quarantine release.
Production Cleanrooms
HEPA-filtered cleanroom suites with positive differential pressure and strict temperature/humidity control to prevent contamination.
In-Process Quality Control (IPQC)
Periodic sampling during granulation, compression, and filling for hardness, friability, disintegration, and fill weight uniformity.
Packaging & Barrier Integrity
Vacuum leak testing of blisters and induction seal inspection to protect formulations against tropical humidity and UV radiation.
Analytical COA Certification
Finished product assay via HPLC, dissolution profiling, and batch stability checks culminating in a signed Certificate of Analysis.
Qualified Batch Release
Independent Quality Assurance manager review and reconciliation of Batch Manufacturing Records (BMR) prior to warehouse dispatch.
Advanced Quality Testing Instrumentation
HPLC, UV-Vis Spectrophotometry, Dissolution apparatus, and stability chambers.
High-Performance Liquid Chromatography (HPLC)
Quantitative active drug assay, dissolution profile analysis, and impurity profiling.
Double-Beam UV-Visible Spectrophotometer
Identification testing and rapid quantitative assay of active raw materials.
Digital Dissolution Apparatus
Verifying drug bioavailability and timed release in compliance with pharmacopoeial monographs.
Digital Friability & Hardness Testers
Monitoring mechanical strength and resistance to transit breakage in tablets.
Official Manufacturing Certifications
Official WHO-GMP and ISO 9001:2015 certificate plaques with zoom/document viewer.
WHO-GMP CERTIFICATE
World Health Organization Good Manufacturing Practices
ISO 9001-2015 CERTIFICATE
International Organization for Standardization (ISO 9001:2015)
The 6 Pillars of Our Quality Management System
HEPA air filtration, moisture barrier assurance, and batch trace record keeping.
Validated assay methods with HPLC, UV spectrophotometry, and Karl Fischer titrators ensuring 100% active constituent accuracy.
Cleanroom zoning with positive differential pressure and HEPA-filtered air handling units preventing airborne particulate contamination.
Temperature and humidity controlled warehousing protecting thermolabile liquids, drops, and soft gelatin formulations.