Quality Management
「 Quality is decided the moment it's designed 」
Quality isn't inspected in
it's designed in
We believe true quality isn't inspected after production—it's determined at the very start of product design.
From formulation and process planning to packaging choices, every step shapes a product's stability, safety, and efficacy.
That's why we anchor quality management in R&D, building a solid foundation for every product through scientific validation and systematic design.
From formulation and process planning to packaging choices, every step shapes a product's stability, safety, and efficacy.
That's why we anchor quality management in R&D, building a solid foundation for every product through scientific validation and systematic design.
Every standard comes from repeated trials
From trial production to stability testing—including long-term and accelerated testing—we repeatedly confirm products stay effective and stable under different conditions.
Only after repeated testing and analysis can we set formulation details, manufacturing SOPs, inspection specs, and quality control standards, then submit them to the Ministry of Health and Welfare for review. Only approved products move to formal production.
Every standard we set builds on our commitment to quality; every validation completed answers consumer trust.
Only after repeated testing and analysis can we set formulation details, manufacturing SOPs, inspection specs, and quality control standards, then submit them to the Ministry of Health and Welfare for review. Only approved products move to formal production.
Every standard we set builds on our commitment to quality; every validation completed answers consumer trust.
Protecting health with the highest global standards
From raw material acceptance and in-process control to final release, every production step follows a complete quality management system that ensures products meet set requirements.
We operate under PIC/S GMP international standards, with a rigorous, traceable quality management system.
To us, quality isn't just compliance—it's a responsibility. Behind every product lies people's hopes and trust in their health.
We operate under PIC/S GMP international standards, with a rigorous, traceable quality management system.
To us, quality isn't just compliance—it's a responsibility. Behind every product lies people's hopes and trust in their health.
Raw Material Management
Great products start with great raw materials
Quality Control at the Source
Raw materials define a product's essence—there's no room for compromise. Before each batch of active ingredients is stored, QC staff sample it against the received quantity and use Raman technology to verify contents match labeling, package by package. Only inspected, approved materials are stored.
Scientific Testing
Once stored, raw materials are kept in suitable conditions based on their properties, tracked by COA and expiration date until they expire. Samples from every tested batch are retained for future traceability. Control never stops, from the first day in storage to the last use.
Full Traceability
We require every supplier to provide batch-by-batch inspection reports, run regular supplier evaluations, and audit factories in person when needed. We follow the latest PIC/S GMP standards—not because regulations demand it, but because we know that problems at the raw material stage undo every effort that follows.
Finished Product Quality Management
Our commitment to quality doesn't end at shipment
Scientific Validation
Every test result depends on a reliable method
Our finished-product testing methods undergo multiple validations—specificity, linearity, accuracy, precision, system suitability, and robustness—before formal use. Only a method proven scientifically sound can serve as the basis for judging product quality. Because only the right method delivers results worth trusting.
Our finished-product testing methods undergo multiple validations—specificity, linearity, accuracy, precision, system suitability, and robustness—before formal use. Only a method proven scientifically sound can serve as the basis for judging product quality. Because only the right method delivers results worth trusting.
Process Validation
Quality isn't just inspected—it's built into manufacturing
Before mass production, every drug undergoes process validation to confirm content and quality in key processes meet consistent standards, and that manufacturing parameters run stably. Rigorous validation ensures every production run holds the same quality level, backing up product consistency and reliability.
Before mass production, every drug undergoes process validation to confirm content and quality in key processes meet consistent standards, and that manufacturing parameters run stably. Rigorous validation ensures every production run holds the same quality level, backing up product consistency and reliability.
Ongoing Stability Monitoring
Our attention to quality doesn't stop once a product ships
Under PIC/S GMP standards, beyond requiring every batch to pass inspection before release, we retain representative batch samples each year and continue stability testing until shelf life expires. Long-term monitoring and data tracking confirm products keep their efficacy, safety, and quality throughout their shelf life.
Under PIC/S GMP standards, beyond requiring every batch to pass inspection before release, we retain representative batch samples each year and continue stability testing until shelf life expires. Long-term monitoring and data tracking confirm products keep their efficacy, safety, and quality throughout their shelf life.
Quality Testing Instruments
Scientific testing makes quality visible
Precision Analytical Equipment
To meet quality standards, we run precision analytical instruments—HPLC, GC, FTIR, and Raman spectrometers—for ingredient identification, content analysis, and quality verification, giving us an objective, reliable basis for testing.
Data-Verified Quality
From raw material inspection and in-process control to final release, every test follows standardized procedures, with data analysis confirming consistency and stability. Every result underpins product safety and efficacy.
Regular Calibration
All testing equipment undergoes regular calibration, maintenance, and performance checks to stay accurate long-term. We believe only trustworthy equipment and data can build product quality worth trusting.
Support Systems
Rigorous climate control and pure water systems make high-quality pharmaceuticals possible
High-Performance HVAC
Pharmaceutical plants rely on high-performance HVAC systems to control cleanliness, temperature, humidity, and microbial levels in production areas, while strictly managing airflow to prevent cross-contamination.
Pure Water System
The pure water system is another key support system. It's especially critical for liquid preparations, where equipment cleaning requires pure water to prevent contamination from bacteria, trace minerals, or chemicals that would lower quality. Chung Mei's pure water system meets the strictest standard—the United States Pharmacopeia (USP).
International Cooperation