Quality System – cGMP Media Manufacturing & Regulatory Compliance

Quality System

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Quality Excellence, End-to-End Assurance

CelluPro integrates exceptional quality management into every aspect, from product design and supply chain to manufacturing, testing, and customer service. We have established an ISO 13485 & ISO 9001 quality management system compliant with international standards, adhering to cGMP guidelines and our quality policy of “Superior Quality, Uncompromising Reputation, Robust Management, and Sincere Service”. We ensure every product exceeds customer expectations through comprehensive process control.

Comprehensive Quality Management

Rigorous Source Control - Material Management

Strict screening and periodic audits of qualified suppliers; established a secondary supplier system with high coverage.

Batch-by-batch material inspection and release; priority use of pharmaceutical-grade raw materials.

Support for client-specified custom raw material procurement and collaborative control to meet unique requirements.

Precise Process Control - Production Management

Utilizes MES system for precise feeding control.

Employs an globally-advanced pin mill automated production line for precise process control, ensuring mixing uniformity and batch-to-batch consistency.

Equipped with a CIP (Clean-in-Place) system capable of reaching Water for Injection (WFI) grade cleaning standards to ensure cleaning effectiveness.

Implements full-process quality monitoring to ensure compliance and effectiveness.

Precise Process Control - Analytical Testing

Equipped with high-precision instruments like UPLC, ICP-OES, and laser particle size analyzers to ensure accurate, reliable, and traceable test data.

Testing methods referenced against international pharmacopoeia standards and subjected to method validation, capable of achieving ultra-low endotoxin levels.

Digital management systems ensure data integrity and traceability.

Independent, controlled testing areas and Class C+A clean laboratories.

Strict Final Verification - Product Management

Testing methods referenced against ChP/USP/EP/JP standards, and testing and release procedure for every batch.

Regular product quality reviews and data analysis.

Partner with leading global and local logistics providers to provide professional ambient and cold chain shipping solutions, ensuring product quality and viability from dispatch to delivery.

Continuously Upgrading International Standards

International Quality System

Full compliance with ISO 13485 & ISO 9001 standards, ensuring our quality management system meets international benchmarks.

Global Regulatory Compliance

Completed multiple product DMF filings, providing solid support for international registrations including dual China-US submissions.

Industry Standard Leadership

As a co-initiator, launched the “Serum-Free Mammalian Cell Culture Medium“ association standard in May 2025, setting a new industry benchmark.

Certificate

ISO9001

ISO13485

ISO22301

ISO14001

ISO45001

Quality Statements

To meet the compliance needs of biopharmaceutical customers, we provide clear statements for the following items and continuously update regulatory information: