- applied to every function / department in Procos site
- based upon the quality assurance principles according to the main international cGMP and regulation guidelines (EMEA, USFDA, ICH), and basically it follows the ICH/Q7A guidelines
- fully documented in every aspect
- well-known with active participation by all the personnel at every level
- focused on the “continuous improvement” philosophy also throughout the possibility of challenging the system with the numerous amounts of successful audits received from our customers and authorities each years
The Quality Unit is involved in all the quality-related matters, focusing the activities to comply to the cGMP The quality system is based on methods and concepts like
- Organizational structure (organization charts)
- Training , development and improvement knowledge and competences of key personnel and human resources
- Qualifications and validations concepts applied to suppliers, equipments, plants, processes, cleaning, instrumentations, analytical methods, computerized systems like as LIMS and SAP
- Strong documentary system
- SOP (Standard Operating Procedure) and MOP (Operative instruction)
- Records and review of documents and raw data
- Interactions between functions (Production, R&D, Regulatory Affairs, Quality, Marketing, Sales, Engineering and Maintenance)
- Internal audit, external audit
In addition the quality system is periodically assessed by Procos customers, which include some of the top pharmaceutical companies, in order to verify the level of compliance of Procos site with cGMP, legal requirement and their own standard.
The combination of the regulatory inspections and the customer’s audit give the opportunity to constantly challenge Procos quality system with the goal to keep it updated to the latest regulatory and industry trend and it is a driver for the continuous improvement philosophy approach.