Safety and Efficacy Challenges and how to overcome it.
Quality, Safety and efficacy are the three crucial pillar of a Pharmaceutical product and to achieve them consistently is a huge task. Various challenges are faced such as Impurities arises in a Drug substance e.g. nitrosamine, lead, chromium etc. which are very harmful for humans if in excess amount, controlling Various critical quality attributes (CQA), Crtical process parameters (CPP) and its control, Quality Material attributes, its stability throughout its life cycle and to be retain in its original form all over its shelf life is a major concern in a drug product, these are some of major challenges which are directly linked with the safety and efficacy of the drug product
To overcome of such challenges and produce the maximal effect of drug we here continuously monitor the critical parameters and analysis of a drug product with respect to their specifications, minimize the risk factor through risk assessment, minimize impurities by recommendation for usage of class-4 solvents, invading new techniques and processes, using stringently various standard guidelines and stringently look into all the parameters in a specification , work upon Pharmacokinetics (ADME) and Pharamcodynamics paramenters relevant to drug product, using various standard literature data etc. and after satisfactory compliment of the all relevant parameters the drug product is allowed to be marketed, hereby overcoming such challenges we can built and provide Safe and efficacious Drug Products.