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Quality Management
QR is built on its commitment to quality. A comprehensive Quality Policy and Quality Management System are established based on GMP and ICH guidelines.
☆ Site mater validation program
☆ Vendor qualification program
☆ Site GMP audit program
☆ Site GMP training program
☆ Product stability program
All production/quality related SOPs, protocols and batch production records must be reviewed and approved by QA before issuing. QA is present in every shift of production to ensure adherence to production documentation, performance, equipment validation, and employee training. Stringent quality control applies throughout the R&D and manufacturing process, supported by QC equipment in-house.
QR has SOPs to follow:
☆ Final product release ☆ Product returns ☆ Customer complaints
Our state-of-the-art production sites are inspected by CFDA to ensure compliance with Good Manufacturing Practice requirements as well as local laws and regulations. An internal audit plan is scheduled by QA at an annual basis. Continuous Improvement is employed so that processes are regularly improved and procedures are regularly updated.
Training
☆ Training program/plan is developed annually to ensure all employees are well trained and qualified.
☆ Training courses are conducted by written test and hands-on evaluation.
☆ New employees must have training before they are qualified to take responsibility in a specific field within the company.
☆ Continuous training program is established for every GMP-related employee.
