QUALITY
QUALITY ASSURANCE & CGMP COMPLIANCE

Uncompromising Analytical Rigor From Molecule to Patient

TOTAL QUALITY MANAGEMENT

Precision Standards Rooted in Pharmacopeial Monographs

At Kyracure Healthcare, quality is not a retrospective testing phase—it is engineered into every stage of development, formulation, and distribution. Formulating strictly under Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), and United States Pharmacopeia (USP) guidelines, we ensure high biological availability, minimal batch variances, and superior clinical response.

Our manufacturing partners operate under certified current Good Manufacturing Practice (cGMP) regulations with automated compression lines, sterile liquid bottling bays, and dedicated air handling units (AHUs) that safeguard product purity.

Through rigorous vendor audits, certified Active Pharmaceutical Ingredient (API) testing, and continuous stability verification, Kyracure guarantees therapeutic excellence across all clinical verticals.

Kyracure Quality Control Cleanroom
WHO-GMP Aligned HEPA-filtered Class 100,000 cleanrooms and ICH Zone IVb stability protocols.
100% Batch Assay & Chromatographic Testing prior to commercial distribution
Zone IVb ICH Real-Time & Accelerated Stability Testing for hot and humid climates
Alu-Alu Cold-Formed Moisture & Light Impermeable Blister Barrier Packaging
QUALITY CONTROL LIFECYCLE

The 4 Pillars of Kyracure Quality Verification

Every unit of medicine passes through sequential verification protocols before being cleared for patient administration.

01

API & Excipient Quarantine

High-purity raw materials undergo HPLC identification, moisture content checks, and microbial limit testing before entering formulation bays.

02

In-Process Controls (IPQC)

Continuous digital monitoring of granule blend uniformity, tablet hardness, friability, disintegration times, and syrup viscosity.

03

Barrier Packaging Integrity

Sealed using pharmaceutical-grade Alu-Alu blister foils, amber glass, and food-grade HDPE bottles with tamper-evident induction cap sealing.

04

ICH Stability Verification

Subjected to 40°C / 75% RH accelerated testing chambers conforming to ICH Zone IVb requirements to validate shelf-life durability.

Kyracure Sterile Facilities
FACILITY SPECIFICATIONS

State-of-the-Art Pharmaceutical Cleanroom Infrastructure

  • HEPA Filtration: Terminal 0.3 micron filters ensuring Class 100,000 / ISO Class 8 air cleanliness in critical processing zones.
  • USP Purified Water Loop: Continuous recirculation loop meeting strict pharmacopeial conductivity and total organic carbon (TOC) thresholds.
  • Segregated AHU Networks: Dedicated Air Handling Units preventing cross-contamination between anti-infectives and general formulations.
  • Batch Traceability: Complete Batch Manufacturing Records (BMR) maintained for 100% accountability from raw API to chemist shelf.
EXPERIENCE PHARMACEUTICAL QUALITY EXCELLENCE

Request batch dossiers
or formulation certificates

Contact Quality Desk