Pharmaceutical Quality Control
Quality control is essential in the drug development program to ensure that the drug substance and other raw materials are suitable for use in your drug product and to ensure that the drug product manufactured meets the highest quality standards required by Aptuit. Our Quality Control group is involved throughout the entire development process, from drug substance and raw material control, through intermediate drug product testing, to finished drug product release testing and stability studies.
Our Quality Control laboratories are fully inspected by the MHRA and FDA. All Quality Control activities and equipment are fully supported by approved GMP documentation.
The services offered by our Quality Control Group include:
- In-process, bulk and finished drug product (packaged) testing
- Drug product stability testing
- Testing of equipment for absence of drug substance and detergent (cleaning verification)
- Microbial testing of drug products (stability and bioburden)
- Method transfer
Additionally, our Quality Control groups support the Qualified Person (QP) certification and release of your drug products for European studies in conjunction with our Quality Groups.