Assurance of quality, safety and efficacy of vaccines through compliance of quality management processes

Abstract

Immunization is one of the most rewarding effective and economical health interventions known to mankind to-date. Since last 50 years successful vaccination campaigns has resulted in extermination of small pox, dropped global polio incidence by 99% and had efficaciously reduced the disability, illness and morbidity caused by the vaccine preventable diseases. Immunization is a crucial constituent behind the efforts taken to meet millennium development goals reducing the mortality in children under-five by over 50 percent, decreasing from 90 to 43 deaths per 1,000 live births between 1990 and 2015.1 To ensure continuous positive results from immunization WHO has stressed upon the need of stringent quality assurance measures which is dependent upon control / monitoring of raw materials; adequacy of production processes, suitability quality control methods and specifications, and control / monitoring of final finished products. The present paper assesses all the essential tools required for the development of a quality biological product. These factors safeguard the safety, efficacy, integrity and quality of vaccines; a result of adequate quality management system which is based upon quality risk management approach (validations, consistency of production, vendor qualifications, independent lot release etc). Efficacy of vaccines