Quality Management System
From research to production quality
Quality is a fundamental core value of the MOL Changes culture, and we always pursue excellence in our products and services with honesty and transparency.MOL Changes has established a quality management system and ensures that each employee operates in accordance with our standard operating procedures in order to fulfill the traceability and optimization of our quality issues.
standards
MOL Changes has an in-house quality management system that meets the highest standards of ISO 9001:2015 part.
Our Quality Management System is managed by our Quality Assurance department, which ensures that all employees adhere to our global business and manufacturing policies and practices to consistently produce products that exceed our customers' expectations.
Our Quality Management System is managed by our Quality Assurance department, which ensures that all employees adhere to our global business and manufacturing policies and practices to consistently produce products that exceed our customers' expectations.
Class 100 sterile laboratory
The MOL Changes Class 100 ultra-high aseptic purification lab has strict zoning control of the area, with upstream synthesis, midstream preparation lyophilization, and downstream packaging and shipping, completely segregated to ensure cross-contamination.
process control
Each product is tested from production to delivery to ensure reliability, including: molecular weight; purity; content; water content; salt content; sterility; PH value; airtightness, etc., to ensure that the quality of the product meets high standards.
quality traceability
MOL Changes has established a complete product quality traceability system, which allows each batch of product to have a unique identification code, which records all personnel involved in upstream synthesis, midstream preparation; purification; lyophilization, downstream encapsulation and shipment, as well as the corresponding process; excipients; time; temperature and other information, which can be used to trace the product quality chain.
Facilities
Our quality is guaranteed also through our highly-efficient and state-of-the-art facilities.
