Pharmaceutical Quality Control and Assurance
WellSpring Pharma’s pharmaceutical quality control and assurance services are backed by their excellent audit history with the FDA and Health Canada to ensure they operate in line with regulatory compliances. It doesn’t stop a QC and QA though – they also provide pharmaceutical analytical testing services and ICH pharmaceutical shelf life testing.
WellSpring has fully equipped chemistry and microbiology laboratories outfitted with HPLC systems, UV/VIS and IR spectrophotometers, USP dissolution apparatuses and auto titrators, ICH-compliant stability chambers, and gas chromatographers.
Their quality control testing services include USP, EP, and BP compendial chemistry testing, non-compendial chemistry testing, micro testing, cleaning, process, and packaging validation, and environmental monitoring.
With respect to ICH pharmaceutical shelf-life testing, WellSpring Pharma’s services include long term stability, accelerated stability, NDA, ANDA, and IND product stability, commercial and comparator stability, drug substance stability, photostability, and protocol and report generation. Their stability storage chambers are validated, temperature and humidity controlled, and on a monitored alarm system with backup power.
For an all-encompassing look into WellSpring Pharma’s clinical manufacturing, packaging, quality, and analytical services, download the brochure.