At Pharma Swede – Egypt Quality Control is an important player, where it covers everything from operational techniques, statistics, and activities that are used to fulfil the requirements as per International Standards as BP and USP, and verify continued system performance and compliance of all inputs, in process and outputs.
Constant Evaluation of quality control data are done to ensure long‑term consistency of analytical results and Verification of determinations of minimum detectable activities
The analyses are carried out by using qualified up to date equipment, for which the operation, cleaning, maintenance, function check and calibration is defined in device-specific SOPs or operating instructions.
The following instruments are used: HPLC, GC, TLC, titration, FTNIR, UV spectroscopy, disintegration, dissolution, density, viscosity determination, pH-value.
In addition, high quality of purified water (PW) as well as water for injection (WFI), microbiological and particulate environmental conditions are regularly monitored (surface tests, air determinations).
All related parameters (identity, impurities, content of effective ingredients, …..) as well as Microbiological tests are fulfilled.