Recently, Dahua Pharmaceutical has successfully completed the Performance Qualification (PQ) for all modules of the QMS (Quality Management System). Verified through multi-dimensional checks including scenario simulation, stress testing, process validation and data traceability, the system operates stably with authentic and traceable data, and all indicators meet GMP requirements.

As supervision in the pharmaceutical industry keeps tightening, the traditional quality management mode relying on paper documents and manual workflow can hardly keep pace with compliance control. To streamline business processes and strengthen quality control, the Quality Department, together with the Production, IT and Engineering Departments as well as a third-party institution, carried out special Performance Qualification of the QMS over about half a month. The work was conducted in strict accordance with regulatory standards such as GMP and Computerized System Validation (CSV) to fully guarantee safe system operation, data integrity and compliant workflows.

This Performance Qualification of the QMS covers ten core quality modules: Change Control, Deviation Management, CAPA Management, OOS Management, Material/Product Release Management, Complaint Management, Non-conforming Product Management, Quality Risk Management, Internal & External Audit Management and Validation Management. It brings the full business chain including pharmaceutical production, testing, product release, risk control, audit compliance and after-market handling into closed-loop control.

Comprehensive verification confirms rigorous permission control, complete audit trails and authentic, traceable data within the system. After deployment, information silos between modules are broken down to enable sharing of quality data and closed-loop business operation, reducing management costs and operational risks.

The implementation of multiple systems (DMS/TMS/QMS) will break down data barriers for documents, training and quality events, forming a dynamic data chain covering “documenting – learning – executing – auditing”. By unlocking dormant data and reinforcing ALCOA++ data integrity, the system enables real-time visualization of deviation trend analysis and CAPA closure, shifting the management mode from “empirical judgment” to “data-driven decision-making”. Internally, it improves the accuracy of risk early warning and standardizes process execution, cutting hidden costs such as recurring deviations and audit findings. Externally, the complete and traceable quality evidence chain consolidates GMP compliance, delivers transparent proof of continuous compliance to regulators and customers, consolidates trust and boosts business competitiveness.

Upholding the corporate philosophy of “Integrity-oriented, Survival through Quality, Solidarity and Struggle, Common Development”, Dahua Pharmaceutical will continuously optimize its digital management and control system, refine quality management, and improve corporate compliance capability and core competitiveness. The company will firmly safeguard the bottom line of pharmaceutical quality and safety, and protect medication safety and public health.