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 cuenta con un sistema de gestión de calidad interno que cumple con los más altos estándares de ISO. 9001:2015 parte.
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.
Clase 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, incluido: molecular weight; pureza; contenido; contenido de agua; salt content; esterilidad; valor de ph; 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; purificación; liofilización, 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.
Instalaciones
Our quality is guaranteed also through our highly-efficient and state-of-the-art facilities.
