Quality

MABION’s Quality Unit consists of the Quality Control Department (QC) and the Quality Assurance Department (QA).The Quality Unit provides and maintains the GMP quality system to support all aspects of biopharmaceutical product manufacturing and to fulfill all present regulatory requirements.

Operating as a pharmaceutical  manufacturer demands constant evaluation of our quality systems by authorities and customers. Our policy is close work of our Quality Unit with internal and customer project teams to fullfill project requirements and ensure regulatory compliance. We are focused on continuous quality improvement and our goal is to provide the biopharmaceutical products that meet highest safety and quality standards.

Quality Control Department

The main activities of the QC Department are control of raw materials, in-process, stability and release testing analyses. In addition, QC is responsible for the microbiological control of products and the production facilities.

•    Environmental monitoring of classified GMP production areas and personel
•    Testing of cell banks, raw materials, and other materials for GMP
production
•    Relase of process materials and cell banks
•    Monitoring of critical product contact utilities (WFI, process media) for cGMP
production
•    Handling of raw material and product reference samples
•    Analyses of samples from process and cleaning validation studies
•    In-process, intermediate and final product release testing (bulk drug
substance, drug product)
•    Process characterization studies
•    Analytical method development and validation
•    Cell based bioassays
•    Physicochemical assays
•    Product sterility studies
•    GMP stability program (intermediates, bulk drug substance, drug product
and placebo)
•    Qualified Person relase of IMP & DP

Quality Assurance Department


The main objectives of our Quality Assurance Department are enhancement of product and service quality, continuous quality improvement and to secure high customer satisfaction.

•    cGMP and regulatory support
•    Quality Agreements with customers and suppliers
•    Audit of external suppliers and contract laboratories
•    Deviation
•    Change Management system
•    Continuous improvement of our Quality System effectiveness
•    Staff training and compliance with the requirements of the quality system
•    Qualification and validation of equipment, process, products & cleaning
•    Regulatory Support