Taking similar action to the GMP procedures, Roowin strictly follows regulatory requirements related to analytical methods with the following guidelines:
. BPF / BPL
. International Conference on Harmonisation
in order to guarantee accordance of the results with the request of the customers.
As a consequence, Roowin is very cautious in qualifying, maintaining analytical apparatus and training its co-workers. Developed methods are validated or transfered following guidelines of ICH Q7.
When needed, Roowin also carries out standardized methods from European and US Pharmacopea.
Roowin aims to get the COFRAC ISO 17025 certification in the future (approved lab for calibration of apparatus and standardized tests).