Quality


At Ausia, we have developed our sterile manufacturing model to support cGmp compliance requirements. Our business practices are prioritized to put quality first, a corporate principle that strives on continuous improvement. We have an experienced Quality Assurance and Control group that provides day-to-day oversight for manufacturing operations. The quality systems are inspected by national and municipal regulatory agencies, contract customers and Ausia’s internal auditing teams.


Ausia’s quality systems are implemented via Standard Operating Procedures and updated in accordance with new regulatory requirements and industrial developments. We have a full complement of microbial and chemical testing activities for raw material, components, in-process and finished goods. Other than employing USP/EP methodologies and monographs, we can also tailor to any client-specific methods.


We believe that the human factor plays an important role in maintaining operation standards and product quality. As a result, we are currently building an Aseptic Processing Management and Training Center, also known as “Sterile University”. This training facility has standard cleanrooms that houses one fully equipped freeze-drying production line and four laboratories – a microbial lab for bacterial identification, a cleanroom behavior analysis lab (i.e. airflow and human interaction analysis), a filter validation lab and a lyophilization cycle development lab. Every aspects of sterile manufacturing can be trained, analyzed and researched in the sterile University.


We treat quality management as a process that should not stop at any point or scarifies for anything. Now firmly established as China’s leading CMO for lyophilized injectables, we are committed to our core principle of “quality first” in customer service, product execution, and process optimization.


 
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