QA department

The Quality Assurance (QA) department plays a crucial role in ensuring that all products meet the highest standards of quality, safety, and efficacy. The department is responsible for overseeing the entire manufacturing process, from the receipt of raw materials to the final release of finished products. By implementing and maintaining the Pharmaceutical Quality System (PQS) up to modern standards, the QA department ensures compliance with Good Manufacturing Practices (EU cGMPs), regulatory requirements, and international standards such as GDPs, ISO 9001:2008, ISO 13485:2003, ΙSO 14001:2015,  and DY8/1348/04. The Department has achieved to combine the different requirements of the pharmaceutical regulations and integrate them smoothly into the applied PQS.  As a result of this, Demo has been also granted with the approval of some of the strictest Legislative Authorities globally and thus, ensures products of high quality.

One of the primary scopes of QA department is the constant monitoring of the manufacturing operations. This is achieved through the performance of self-inspections and spot-checks, monitoring the production environment, verifying the cleanliness and calibration of equipment, validation of processes and ensuring that all procedures are followed according to the established Standard Operating Procedures (SOPs). The activities of the department also include the overview of new production areas’ design, in accordance with the applicable standards and requirements and the monitoring of critical partners of the company to ensure the same high standards are applied for the supplied materials and services). Our operation is based on three principles planning, proper design, and continuous monitoring.

The QA department also collaborates closely with other departments, such as Quality Control (QC), Research and Development (RnD) and Regulatory Affairs, to ensure a holistic approach to quality management. This collaboration is essential for the successful implementation of quality systems and for addressing any quality-related issues that may arise.

The Department’s personnel consist of competent scientists in various matters of expertise and is structured into four teams focusing to the different Wings of production. Through continuous training and development programs, the QA department ensures that all personnel are well-versed in quality standards and practices, fostering a culture of quality throughout the organization. It is worth noting that Demo’s Quality Assurance Department is among the most numerous across the pharmaceutical industry Greece.