Quality Policy
At Fonow Medicine OEM, quality is not just a checkbox—it is the foundation of our manufacturing philosophy. We are dedicated to producing safe, effective, and compliant pharmaceutical products.
Patient Safety First
Every decision we make is guided by our responsibility to the ultimate end-user: the patient. We accept no compromise on safety.
Strict GMP Compliance
We adhere strictly to cGMP (Current Good Manufacturing Practice) guidelines as mandated by the FDA, NMPA, and international standards.
Data Integrity
We maintain complete, consistent, and accurate records (ALCOA+ principles) to ensure full traceability of every batch manufactured.
Key Quality Attributes
We monitor these five pillars relentlessly for every production run.
The Quality Lifecycle
Our Quality Assurance system spans the entire product lifecycle, from raw material receipt to final distribution.
Raw Material Control
Rigorous testing of all APIs and excipients before they enter the warehouse. Vendor audits and qualification are mandatory.
- Identity testing (IR/HPLC)
- Purity and Impurity profiling
- Microbial limit testing
In-Process Control (IPC)
Real-time monitoring during manufacturing (mixing, filling, sealing) to ensure uniformity and consistency.
- pH and Viscosity checks
- Fill weight verification
- Leak testing of tubes/jars
Final Release Testing
Comprehensive analysis of the finished product. Only the Quality Unit has the authority to release batches.
- Assay of Active Ingredients
- Sterility / Microbial limits
- Stability data verification
Regulatory Compliance
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FDA
U.S. Food and Drug Administration Registered Facility (FEI #3009957429). Compliant with 21 CFR Part 210/211.
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NMPA
National Medical Products Administration Fully licensed for pharmaceutical production in China.
ISO Standards
Continuous Improvement
We utilize the PDCA (Plan-Do-Check-Act) cycle to constantly elevate our standards.
Internal Audit Performance (Annual)
Average score across GMP subsystems (Facilities, Equipment, Production, Lab Controls).