Simpex pharma believes in, quality has to build up at initial stage of product development this is very crucial stage and simpex treats every products as its baby. Product designed is considered as first trimester in development. What quality R&D has to be produce it has to maintain throughout the lifecycle by quality assurance department. Patients and disease condition is the first criteria for selection of drug and route of administration. Being in consideration all these parameters and patient requirement QTPP (quality target product profile has to decided). On the basis of QTPP the CQA (critical quality attributes) has to decide. On the CPP (critical process parameters has to be controlled) selection of excipients and there process control has to be decided to achieve pre decided quality target product profile for the benefit of recipients.