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

Abstract

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.