Comprehensive Quality System
Quality Assurance
Strict Quality Management
Our quality assurance system is set against ICH Q7, which stands for the most stringent quality management system enabling KinOmega products to meet the pharmaceutical quality standards. KinOmega always give the first priority to the QA/QC in all our operations. Quality assurance and quality control goes through from raw material, in-process and finished product release, which is thoroughly performed in each process step by responsible department and the qualified personnel. Our quality system keeps improvement and perfection to ensure the top product quality, which enables us to deliver the quality product to our respected customers.
- Critical raw material supplier audit
- Contract laboratory audit
- Continuous improvement of the quality management system
- Make quality standards and specification for raw material, in-process products and finished products
- Regular internal quality audit and self-inspection to compliance with the cGMP(current Good Manufacturing Practice)
- Maintain and improve the standard operating procedures (SOPs)
- Validate each production and testing process
- Maintain full traceability records of each KinOmega product manufactured at ourfacility
- On-site Q/A monitor and control in each process step
- Organize and perform on-time personnel training as per training plan
Quality Assurance
Quality Control
Sophisticated Equipment Strictly Analysis
Data integrity is the first rule our lab is following. KinOmega analyzing center (laboratory) has been inspected and approved by USFDA, KFDA and Japan PMDA. It is equipped with the most sophisticated equipment, highly trained and qualified personnel. Each product is strictly analyzed from the raw material, in-process control and finished product release. The test equipment and testing method has to be carefully calibrated and validated to ensure the reliable and accurate testing results. In addition to the regular testing, our lab is responsible for research and development enabling KinOmega to keep the cutting-edge technologies and unparalleled quality.
- Carry out each operation strictly in compliance with GLP (Good Laboratory Practice)
- Perform full testing from raw material, in-process and finished products as per set quality specification
- Validate the testing procedures and methods
- Make and perform on-going stability study
- Make and perform the research and development to perfect the technique
Quality Control
Quality Control
Certificates