QUALITY ASSURANCE & CONTROL
Our Quality Team combines Quality Assurance and Quality Control. The teams is comprised of 16 units, whose objective is to ensure the highest level of production quality through continuous improvement of our processes.
Our chemicals laboratory is fully equipped with all necessary equipment to conduct raw material, semi-finished, and finished product testing. Specifically, the lab is equipped with:
Stability testing takes place within climate-controlled environments compliant with ICH guidelines: 25°C/60% HR, 30°C/65% HR, 40°C/75% HR. Lower and higher temperatures and humidity may be used upon client request or for special validation procedures and different climatic zone.
The Quality Control department performs all of the following:
The Microbiology lab is responsible for conducting all testing as outlined in the client’s registration file and is responsible for conducting all necessary environmental sampling and analysis.
The microbiology lab:
Our Quality Assurance Department employs a team of highly skilled experts that specializes in the following key elements:
We also provide the following upon client request: Product Quality Review (PQR), ICHQ3D Risk Assessment, and Nitrosamines