Method validations are carried out as per latest regulatory guidelines for assay, related impurities, chiral purity, preservative & anti-oxidant content, residual solvents, particle size distribution, in-vitro dissolution, physicochemical and wet chemistry methods.
At GVK BIO, Analytical method validations are executed in alignment with stringent SOP, which is based on ICH Q2 guidelines and in adherence to cGMP & GLP requirements.
Validation experimentation includes:
- Forced degradation studies
- Quantitation limit/Detection limit
- Stability of analyte in solution
- Robustness studies
- System suitability
Good documentation practices are followed throughout the process and an exhaustive and scientifically documented validation report is provided to the customers.