Physico-Chemistry Laboratory
Our mission is to support you in the compliance of your products by providing quality control analysis services as part of validation and release of production batches
Overview
Our team of the Physico-Chemistry Laboratory offers extensive services including:
- Analytical method transfer for raw materials, drug substances, excipients, drug products from your laboratory or our Analytical Development Laboratory.
- Release testing of incoming materials, in-process controls, utilities, finished products and incoming inspection of packaging components
- Stability testing
- Cleaning validation support and testing
All the services offered by the Physico-Chemistry Laboratory are performed according to GMP requirements and can be tailored to your specific needs.
As physico chemistry laboratory, our mission is to support you in the compliance of your products by providing quality – control analysis laboratory services as part of validation and release of production batches. Stability studies or forced degradation (ICH) linked to drug substances, excipients, drug products and finished products could be tackled by the know-how of our expert team.
All of the analysis will be performed in a full GMP/FDA compliant environment.
Certificates of analysis will be approved by the qualified person (QP) of the CDMO site.
Capacities
The Quality Control department (QC) is separated in four dedicated area: Samples Reception, Physico-Chemistry Laboratory, Microbiological Laboratory and Analytical Development Laboratory.
In the reception area, samples collected in the production area, in the warehouse and in the utilities production zone will be delivered. These samples will be then registered and stored in the reception area before being analysed in the laboratories. According to the samples storage conditions, they will be stored at room temperature on a dedicated shelf or in a fridge or in a freezer located in the reception area. Incubators dedicated to Environment Monitoring (EM) tests and incubators for mediafills (MDF) conservation will also be installed in the reception area.
The physico-chemistry release activities will be realized in the Physico-Chemistry Laboratory (189 m²). Some rooms will be dedicated to specific activities: chromatographic analysis, washing, weighing, reagents storage and freezers storage. In the open space, fume cupboards and benchs for samples preparations and small benchtop equipment will be installed.
