The requirement of the drug design process imposes to be supported by reliable partners of quality.
For the synthesis of active pharmaceutical ingredients, the GMP rules (Good Manufacturing Practices) ensure the quality of the synthesized product, and its absolute traceability.
Within this framework, the customers of GMP synthesis elect a company expert in GMP audits, to check the conformity of Roowin’s procedures and equipments to this reference frame.
Each process of synthesis is duly described before any implementation, and each stage documented and checked in an exhaustive way. At the end of the synthesis, the final batch file includes the results of analysis of the raw materials, of the intermediates and the complete analysis of the final molecule. The GMP procedures also impose high standards for the purity of the obtained products and the quality of the analysis.
All the Roowin teams ( laboratories, kilo lab, pilot plant and production workshop) are used to work following these strong requirements.
As for ISO 9001, GMP guidelines form a system of continuous improvement .