Quality Management System QMS
In Synoptis Pharma we are committed to the quality, safety and efficacy of our products and services. Our Quality Management System comply with the EU strictest guidelines.
Key features of Quality Assurance and Control (QA/QC):
- Implementation of ICH Guideline for Product Quality Management
- Implementation of cGMP, HACCP, GHP or ISO standards as per EU Guidelines
- Qualified Person (QP) responsible for Product Release
- Vendor Audit System – pre-audit questionnaire & on-site audit
- Product traceability & market release through integrated SAP system
Every our product is methodically checked in compliance with the approved specification prior to the launch. We are responsible for the product quality along its entire life therefore we dispose of a referential trials archive and stability research of our products (not only for the medicinal products but also for the dietary supplements and other nutrient products).
One of the important tasks of the R&D Department is caring for the products preserving their highest quality throughout the entire process and throughout its use-by-date period. The durability of the medicinal products and dietary supplements is mostly determined by the environmental factors such as temperature, humidity, visible radiation and the type of packaging.
The individual product features determine the influence of the environmental factors on the durability of products. Therefore, for each product the stability tests are conducted. The purpose of these tests is to state the life period of the product and best storage conditions. Climatic chambers (ageing) allow for the stability tests in the accelerated conditions. Therefore, we can forecast the products durability and shorten the tests period.