At Zifam Pyrex Myanmar Co., Ltd., quality is embedded into every stage of our operations through a robust and comprehensive Quality Management System (QMS). This system ensures that all products consistently meet global regulatory standards and the highest levels of safety, efficacy, and reliability.

Our QMS is designed to provide end-to-end control, traceability, and continuous improvement, supporting both regulatory compliance and operational excellence.

The QMS encompasses structured and systematic processes, including:

• Change control management to ensure controlled implementation of any modifications
• Deviation handling and investigation systems for timely identification and resolution of issues
• Corrective and Preventive Actions (CAPA) to proactively address non-conformances and mitigate risks
• Market complaint and product recall management to ensure patient safety and regulatory compliance
• Periodic internal audits and self-inspections to maintain continuous compliance
• Quality System Management Reviews (QSMR) and Annual Product Quality Reviews (APQR) to evaluate system performance

These integrated processes ensure consistent product quality, regulatory compliance, and continuous system enhancement.

Quality Assurance (QA) at Zifam Pyrex Myanmar Co., Ltd. plays a central role across the entire product lifecycle—from qualification and validation of equipment, facilities, and processes to the final release and dispatch of finished products.

• All raw materials and packaging materials are sourced from qualified and globally recognized vendors
• Suppliers are approved based on compliance with international standards such as USFDA, TGA, and EU-GMP
• Materials undergo rigorous testing based on pharmacopoeial standards (USP, Ph. Eur., BP) or validated in-house methods
• Release is granted only after meeting strict quality specifications

This ensures consistent input quality for all manufacturing processes.

QA ensures that:

• Manufacturing processes are conducted under validated and controlled conditions
• All operations comply with WHO-GMP and PIC/S guidelines
• Quality standards are maintained consistently across all batches

Self-inspections and internal audits are conducted periodically to ensure continuous compliance and operational excellence.

QA functions as the central authority for quality governance, overseeing:

• Risk assessment and mitigation strategies
• Continuous monitoring of production and quality data
• Integration of analytical results from ISO 17025 (ANAB-accredited) laboratory systems
• Ongoing evaluation of process performance and product quality

This ensures that every product released reflects consistent integrity, safety, and global quality standards.

Through a strong QMS and proactive QA systems, Zifam Pyrex Myanmar is committed to:

• Delivering safe, effective, and high-quality pharmaceutical products
• Maintaining full regulatory compliance across all markets
• Driving continuous improvement and operational excellence
• Building long-term trust with healthcare professionals, partners, and patients