Thank you for the information provided.
If iam not mistaken the above mentioned criteria are included in the feasibility study for performing a retrospective validation.
How are going to select among quality control parameters for tablets and Liquids (which includes Uni.Wt, Assay, Thickness, Hardness, pH, Viscosity, wt/ml and Assay) for analyzing and applying the statastics for capability study?
Plz do reply me.
Thanking you & Regards,
Offcourse apply process capabilty test on varies QC test including chemical and physical as defined above and determine and validate the processes. and also it is better to perform annual product review. By applying six sigma appraoch evaluate the process limits.