Skip to main content

zendavit.com

Manufacturing Standards & Quality Assurance

Manufactured in state-of-the-art cGMP-compliant cleanroom facilities adhering to rigorous international pharmacopeial standards, analytical release assays, and batch traceability.

 

The 6 Pillars of Product Integrity

Standard Operating Procedures (SOPs) governing every step of the Zendavit Forte supply chain.

 
 

GMP & ISO Certified Cleanrooms

Formulated in Class 100,000 (ISO Class 8) climate-controlled cleanroom suites featuring HEPA air filtration, positive pressure cascades, and continuous particulate monitoring.

In-Process Quality Control (IPQC)

Continuous real-time checking of capsule fill weight uniformity, shell moisture content, shell integrity, and seal tightness across high-speed rotary encapsulation lines.

HPLC Potency & Assay Release

Every finished commercial lot undergoes validated High-Performance Liquid Chromatography (HPLC) to confirm labeled ginsenoside and vitamin levels prior to QA release.

Alu/PVC Hermetic Blistering Lines

High-speed automated blister cavity packaging with inline visual pinhole detectors and ultrasonic sealing to guarantee 100% moisture barrier protection.

CTD / ACTD Regulatory Dossiers

Complete Common Technical Documents (CTD Modules 1–3) and ASEAN Common Technical Dossiers (ACTD) ready for international Ministry of Health product registrations.

Zone IVb Stability Validation

Real-time and accelerated ICH stability testing conducted under 30°C / 75% Relative Humidity conditions validating the 36-month shelf life across tropical export markets.