GOOD MANUFACTURING PRACTICE (GMP), GOOD AGRICULTURAL PRACTICE (GAP), & TOTAL QUALITY MANAGEMENT (TQM)
KO DA Pharmaceutical is among the first of TCM manufacturers ever to attain Good Manufacturing Practice (GMP), ISO 9001:2015 Certification in Quality Management certified by SGS, ISO 14064:2006 Greenhouse Gas Verification by Det Norske Veritas and ISO 17025:2005 Laboratory & Testing Centre certified by Taiwan Accreditation Foundation (TAF). KO DA remains one of the only herbal manufacturers in the world with Good Agricultural Practice (GAP).
1. RAW MATERIAL SELECTION
When sourcing raw materials, KO DA implements a strict Source Management system where the agricultural environments in China are assessed and formal contracts are enforced with farmers after the assessments. The contracted farmers are required to create detailed production records in accordance to Good Agricultural Practice (GAP). Additional requirements are to inspect and record water and soil conditions before and after harvest, confirm origin of herb by testing samples of species and its properties, and adhere to all other planting specifications required by KO DA.
2. CLEANROOM STORAGE CLASS 100,000
Raw materials that qualify are stored onsite in KO DA’s Cleanroom Class 100,000:
Temperature: 19-27 ℃ Humidity: 40-60 RH% Pressure differentials: >5 Pa(0.5 mm H2O) Air recirculation(%): 99.99% Air filtration system: 100,000 HEPA.
3. TAF LABORATORY TESTING
Raw material identification and quality control testing for safety, stability and efficacy.
4. CLEANING & PREPARATION
Raw materials are repeatedly soaked and rinsed in running water to free the materials of any dirt or impurities. The clean raw materials are selected and cut into standard-sized thin slices.
5. TRADITIONAL PREPARTION & PRECISE SCALING
Raw materials are sorted to receive different treatment and are processed according to their unique specifications and characteristics. Each raw material is precisely weighed according to the weight ratio adopted from ancient prescriptions.
6. ESSENTIAL OIL & OPTIMUM EXTRACTION
The proper solvent is selected according to medical books and the raw material is thoroughly extracted for its effective components. KO DA attains optimal extraction via cyclic-style extraction under controlled temperature, pressure, water and duration using fully automated and computerised equipment under vacuum and low-temperature conditions. KO DA’s first self-developed high concentration essential oil extraction technology preserves the precious herbal essential oil, and reintroduces the precious oil during the later stage of the manufacturing process in order to maximise the efficacy and reliability of KO DA’s finished products.
7. FILTRATION & CONCENTRATION
After extraction, the herbal extracts are filtered with a fine sieve to remove dregs from the extracts. The filtered herbal extracts are concentrated under vacuum and at low temperature to increase the stability and shelf life.
8. TAF LABORATORY TESTING
Raw material identification and quality control testing for safety, stability and efficacy.
9. FLUID BED SPRAY GRANULATION & PRODUCT VARIATIONS
The concentrated extracts and certified non-genetically modified (non-GMO), gluten-free corn starch excipient are coagulated into even-sized granules by fluid bed spray drying equipment for consistency. Product variations include: Granule, Powder, Compressed Tablet, Honey-Pill and Capsule.
10. CERTIFICATE OF ANALYSIS (COA)
Each and every batch of KO DA’s finished product is TAF laboratory batch certified and presented with the Certificate of Analysis that accurately reflects test results to the nearest parts-per-million (ppm).
11. FULLY AUTOMATED PACKAGING
In accordance to the requirements of pharmaceutical-grade guidelines, KO DA’s concentrated extracts are safely packaged using fully automated equipment which prevents any possibility of human inconsistencies or contamination.
12. WORLD DISTRIBUTION & EXPORT
KO DA Pharmaceutical currently exports to Australia, Austria, Brazil, Canada, China, Germany, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Africa, South Korea, Switzerland, the United Kingdom and United States of America.
13. CLEAN IN PLACE CLEANING SYSTEM (CIP)
KO DA utilises professional Clean-In-Place (CIP) cleaning systems to rinse the internal part of machines and pipes without contamination by human hands or other external factors. This ensures that KO DA’s manufacturing equipment is always clean, aseptic and safe.
TOTAL QUALITY MANAGEMENT (TQM)
KO DA Pharmaceutical continually surpasses the industry benchmark by delivering superior products and services to the world. In particular, KO DA is led by its award-winning Total Quality Management (TQM) approach to long–term success; through continuous improvement, science and innovation, highest quality assurance, ethical conduct, and international customer satisfaction.