SPbSRIVS conducted an analysis of the Pharmaceutical Quality System (FQS). Apart from being a milestone event for any pharmaceutical company, it is also a prerequisite stipulated by the ISO 9001 standard (clause 9.3.1 of ISO 9001:2015) and the Good Manufacturing Practice principles.
The FQS analysis allows the process managers to present the results of teamwork in the field of quality management and production to senior management. It is the Quality Management Department that first promoted quality enhancement in the SPbSRIVS, and today all the divisions of the Institute are involved in the quality management process.
By giving the senior management insight into the functioning of the whole system, FQS analysis allows them to be better involved in the process and make more informed operational decisions based on this analysis.
The employees of the Quality Assurance Department shared good news about the lower number of discrepancies, the decreased severity of inconsistencies detected during external and internal inspections, the increased effectiveness of the introduced CAPAs, streamlined work with suppliers and contractor facilities. The analysis has shown that the manufacturer faced neither complaints nor product recalls from the market in 2019-2020.
In 2021, the SPbSRIVS intends to further pursue its quality development policy. To that end, the Institute is going to implement a number of measures to ensure data integrity, to pass scheduled audits, to introduce a quality monitoring system to the ISPE standards and a quality cost management system.
