Vaccines develop the immune response against disease and are the intricate biological entities containing one or more than one antigen beside an adjuvant. In order to ensure that manufactured vaccines are safe, potent, and of consistent quality, four primary controls of bio safety namely: PPE; facility design; SOPs and leadership are required at every step of manufacture and quality control testing until the administration of vaccine to the target population. The safety and efficacy of testing methods are based upon the data validation of several years. With time the advancements in vaccine production techniques has brought about advancements in testing techniques as well. These improvements have enabled scientists to detect highly sensitive potential hazards which were a dream few years back. An increasing assemblage of physico-chemical methods permits much better characterization of the product. In addition to advance tests vaccine regulations necessitate quite a few numbers of strategies to ensure the safety and potency of the vaccine/serum. These measures include cell banking, seed lot system, supplier audits, master seed, compliance with good manufacturing practices, independent lot release from National Regulatory Authority and increased (pre and post) marketing surveillance to look for possible adverse effects following immunization (AEFI). Together all these methods ensure the quality of vaccine for the purpose it is manufactured against.

Communicable diseases remain the leading cause of mortality worldwide in past. Children and adolescent were the most affected individuals. However, the development of vaccine played a vital role in decreasing mortality and increasing life expectancy. Currently most of vaccines are based on utilizing animal pathogens and use of animals. This use of animal in quality testing of vaccines is inevitable. Over the past century, concern about animals' interests was limited to ensure that animals be treated humanely and not subjected to unnecessary sacrifice and sufferings. However, with the rise of 3Rs concept the global scenario for use of animals is being changed a little. The current review addresses the refinement, reduction and replacement aspects of animal use in vaccine testing. It also dialogues about challenges to implement 3Rs and gadget this key concept for effective quality testing.The acceptability and implementation of 3Rs concept is based on good manufacturing practices, good in-process quality control and validated procedures and processes. It is easier for new vaccines to adopt this concept. However, several difficulties are still experienced in theimplementation of 3Rs principles for vaccine potency assays. Thus, insistent exploration is obligatory by bothhealth industries and regulatory agencies for the implementation and validation of robust 3Rs approaches around the globe.