Quality & Compliance Operations (QCO) is a service rendering organization aiming at delivering safe medicines to our patients and in doing so contribute to the success of our company. QCO is part of a matrix organization, the Global Pharmaceutical Supply Chain, and in Leiden consists of four divisions: Quality Control (laboratories), Quality Assurance, Compliance and Validation.
Quality Control (QC) is responsible for performing various tests related to the production of our medicines. The department tests raw materials, interim- and final product and takes care of the microbial checks of the production areas and processes, according to the guidelines set out for Good Manufacturing Practices / Good Laboratory Practices.
Quality Control consists of four laboratories and a support department:
- Raw Materials: monitors the quality of incoming production raw materials;
- Microbiology: checks the microbial quality of the incoming raw materials, interim and final product;
- In Process Control: is responsible for the quality assurance during the production process;
- Final Product Testing: tests final product on identity, purity, efficacy and tenability;
- Laboratory Services: coordinates maintenance analytical equipment, manages the sample flow and the laboratory supplies.
Quality Assurance (QA) has a primary responsibility for the quality control/assurance program (Quality Management System) of the company and as such is closely involved in the primary production and the production supporting processes. QA is end responsible for the release of bulk product and semi-finished product for internal and external customers.
Compliance is active in the areas of Supplier Quality, GMP Compliance advice and projects, Inspection Management and GMP Training.
Validation sees to it that all production systems, utilities and automation systems are tested and validated according to the applicable guidelines. Validating means, checking for efficacy and reproducibility. The validation department is also a center of expertise and first point of contact for validation matters.
