Quality Management
「 Quality starts with design. 」
Quality isn't inspected in.
It's designed in.
We believe true quality cannot be achieved through inspection alone—it is built into the product from the very beginning.
From formulation and process design to packaging choices, every step contributes to a product's stability, safety, and efficacy.
That's why we embed quality management into R&D, building a solid foundation for every product through scientific validation and systematic design.
From formulation and process design to packaging choices, every step contributes to a product's stability, safety, and efficacy.
That's why we embed quality management into R&D, building a solid foundation for every product through scientific validation and systematic design.
Every standard is built on rigorous testing.
From pilot batches to stability testing—including long-term and accelerated studies—we repeatedly verify that products maintain their efficacy and stability under various conditions.
Only after rigorous testing and analysis do we establish formulation specifications, manufacturing SOPs, inspection specifications, and quality control standards. These are then submitted to TFDA for review. Only approved products proceed to commercial production.
Every standard we set reflects our commitment to quality, and every validation we complete reinforces consumer trust.
Only after rigorous testing and analysis do we establish formulation specifications, manufacturing SOPs, inspection specifications, and quality control standards. These are then submitted to TFDA for review. Only approved products proceed to commercial production.
Every standard we set reflects our commitment to quality, and every validation we complete reinforces consumer trust.
Protecting health through global quality standards
From raw material acceptance and in-process controls to final product release, every step of production is governed by a comprehensive quality management system to ensure that products meet defined quality requirements.
Our manufacturing operations comply with PIC/S GMP standards, supported by a rigorous and fully traceable quality management system.
To us, quality isn't just compliance—it's a responsibility. Behind every product is the trust people place in us to protect their health.
Our manufacturing operations comply with PIC/S GMP standards, supported by a rigorous and fully traceable quality management system.
To us, quality isn't just compliance—it's a responsibility. Behind every product is the trust people place in us to protect their health.
Raw Material Management
Quality starts at the source.
Quality Control at the Source
Raw materials are fundamental to product quality—there's no room for compromise.Before each batch of active ingredients is released for storage, QC staff conduct sampling based on the quantity received and use Raman spectroscopy to verify the identity of the contents against the labeling on each package. Only inspected and approved materials are released from quarantine for storage.
Scientific Testing
Once stored, raw materials are maintained under appropriate conditions based on their properties, with their quality status, COAs, and expiration dates carefully tracked throughout storage.Retention samples are kept from each tested batch to ensure traceability when needed.Quality control never stops—from the moment a material enters storage to its final use.
End-to-End Traceability
We require every supplier to provide batch-specific inspection reports. We also conduct regular supplier evaluations and on-site factory audits when needed.
We operate in accordance with PIC/S GMP standards—not because regulations demand it, but because we believe quality must be protected from the very beginning.
We operate in accordance with PIC/S GMP standards—not because regulations demand it, but because we believe quality must be protected from the very beginning.
Finished Product Quality Management
Our commitment to quality doesn't end at shipment
Analytical Method Validation
Every test result depends on a reliable method.
Our finished-product testing methods undergo rigorous validation—including assessments of specificity, linearity, accuracy, precision, system suitability, and robustness—before formal use.
Only scientifically validated methods are used to assess product quality. Because reliable quality decisions begin with reliable analytical results.
Our finished-product testing methods undergo rigorous validation—including assessments of specificity, linearity, accuracy, precision, system suitability, and robustness—before formal use.
Only scientifically validated methods are used to assess product quality. Because reliable quality decisions begin with reliable analytical results.
Process Validation
Quality is built into every step of the manufacturing process.
Before commercial production, each manufacturing process undergoes rigorous process validation to confirm that critical process parameters consistently produce products that meet established quality specifications.
Rigorous validation helps ensure that every production batch consistently meets established quality standards, supporting product consistency and reliability.
Before commercial production, each manufacturing process undergoes rigorous process validation to confirm that critical process parameters consistently produce products that meet established quality specifications.
Rigorous validation helps ensure that every production batch consistently meets established quality standards, supporting product consistency and reliability.
Ongoing Stability Monitoring
Quality monitoring continues long after a product is on the market.
In accordance with PIC/S GMP standards, every batch must pass quality testing before release. We also retain representative batch samples and conduct ongoing stability testing throughout the assigned shelf life.
Long-term monitoring and data analysis help confirm that products maintain their efficacy, safety, and quality throughout their assigned shelf life.
In accordance with PIC/S GMP standards, every batch must pass quality testing before release. We also retain representative batch samples and conduct ongoing stability testing throughout the assigned shelf life.
Long-term monitoring and data analysis help confirm that products maintain their efficacy, safety, and quality throughout their assigned shelf life.
Quality Testing Instruments
Scientific testing makes quality visible
Precision Analytical Equipment
Scientific testing makes quality measurable.
Precision Analytical Equipment
We use advanced analytical instruments—including HPLC, GC, FTIR, and Raman spectrometers—for identity testing, assay, and quality verification, providing an objective and reliable basis for quality assessment.
Precision Analytical Equipment
We use advanced analytical instruments—including HPLC, GC, FTIR, and Raman spectrometers—for identity testing, assay, and quality verification, providing an objective and reliable basis for quality assessment.
Data-Driven Quality
From raw material inspection and in-process control to final product release, all testing is conducted according to standardized procedures, with data analysis confirming consistency and stability. Every result supports product safety and efficacy.
Regular Calibration
All testing equipment undergoes regular calibration, maintenance, and performance checks to ensure continued accuracy and reliability.We believe that reliable equipment and trustworthy data are essential to ensuring quality.
Facility & Utilities
Controlled environments and purified water systems provide the foundation for high-quality pharmaceutical manufacturing.
High-Performance HVAC
Pharmaceutical manufacturing facilities rely on high-performance HVAC systems to maintain controlled environmental conditions, including temperature, humidity, cleanliness, and microbial levels, while carefully managing airflow to prevent cross-contamination.
Pure Water System
High-quality water is essential to pharmaceutical manufacturing, particularly for liquid preparations and equipment cleaning. Our Purified Water System is designed to minimize microbial, chemical, and mineral contamination and complies with relevant USP quality requirements.
International Cooperation