Our Philosophy

Quality is a Culture, Not a Department

At Zyvita Healthcare, quality is built into every process, every decision, and every action — from raw material procurement to final product release. Our Quality Management System is a fully documented, validated, and continuously improving framework.

  • ICH Q10 Pharmaceutical Quality System (PQS)
  • Batch Manufacturing Records (BMR)
  • CAPA system with root cause analysis protocols
  • Annual product quality reviews (APQR)
  • Rigorous vendor qualification and incoming material control
  • Complete traceability across all production stages
Quality Systems

Our Quality Management Framework

Integrated quality systems covering every stage from incoming materials to market release.

Documentation Control

Comprehensive SOPs, BMRs, and qualification protocols — all version-controlled and accessible via validated document management systems.

In-Process Controls

Continuous in-process monitoring with automated verification of specifications at every production stage.

CAPA System

Structured Corrective and Preventive Action system with mandatory root cause analysis and effectiveness verification.

Stability Studies

ICH-guided stability testing across real-time and accelerated conditions for all product types and packaging configurations.

Analytical Capabilities

QC Laboratory & Testing

Our Quality Control laboratory performs compendial and validated analytical tests in-house — ensuring data integrity and maintaining complete chain of custody.

HPLC / UHPLC Analysis
GC
UV-Vis Spectrophotometry
IR
Dissolution Testing
Microbiological Testing
Karl Fischer Water Content

All analytical instruments are:

  • Qualified (IQ/OQ/PQ) and periodically re-qualified
  • Calibrated with traceable reference standards
  • Compliant data management systems
  • Maintained under a validated preventive maintenance schedule

Batch Release Policy

No batch is released for distribution without full compliance testing, thorough review, and Certificate of Analysis (CoA) issuance. Our release protocol ensures every shipment meets specification — without exception.

Confidence in Every Batch

Partner with a manufacturer committed to rigorous quality systems. Let's discuss your compliance requirements.

Contact Our Team