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公司简介

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  • Quality Management

Quality Management

Yangzhou Princechem has always placed quality at the heart of its sustainable development, establishing a comprehensive Quality Management System that spans the entire product lifecycle. This system ensures full-process control—from raw material sourcing and process development to finished-product delivery—guaranteeing product safety, consistency, and traceability.
Leveraging extensive experience and expertise across CRO, CMO, and CDMO operations, we align our practices with international standards such as ISO 9001, ICH Q7, and GMP, consistently meeting the rigorous quality requirements of leading pharmaceutical companies both in China and abroad.

Full-Process Control

  Our quality management encompasses all critical stages—including R&D, production, inspection, storage, and transportation—ensuring consistently high standards across the entire product lifecycle.

Risk Assessment Mechanism

  Guided by the “Quality by Design” (QbD) philosophy and employing scientific risk assessment tools such as FMEA, we systematically optimize process flows and implement measures to minimize risk.

Data Integrity Assurance

  We strictly follow ALCOA+ principles (traceability, clarity, contemporaneity, originality, accuracy, etc.) to ensure that all quality data are authentic, reliable, and compliant with international standards.
Through a structured and systematic quality and audit system, Yangzhou Princechem has passed numerous domestic and international certifications and customer audits, earning the trust of global clients. We continue to invest in enhancing our quality management capabilities, helping customers achieve compliance and sustainable supply chain management.

 

  Quality Philosophy

  Customer-Oriented: Centering on customer needs, we provide compliant, stable, and high-purity intermediate products.
  Continuous Improvement: We drive the upgrade of our quality system through the PDCA cycle (Plan-Do-Check-Act).
  Scientific Decision-Making: Based on data analysis and validation, we ensure process stability and reproducibility.

  Quality Policy

  Scientific management, excellent quality, satisfactory service, and continuous improvement.

  Quality Commitment

  Provide complete quality management system documents (such as company qualifications, COAs, and MOAs) according to customer requirements.
  Respond to customer quality complaints within 24 hours and implement closed-loop management for root cause analysis (RCA).