Question

Factors playing an important role in the quality control of vaccines are

Answer 1

Biological products, including vaccines, are distinguished from chemical pharmaceuticals by being derived from living organisms with a molecular composition too complex to be defined by physical or chemical means. In addition, the inherent variability of living organisms, the potential for contamination of materials with agents coming from starting materials or the environment, require special quality control and quality assurance mechanisms.

While the manufacturer has the primary legal responsibility for the safety, quality, and efficacy of the products they sell, the National Regulatory Authorities (NRAs), in particular in the countries where vaccines are manufactured, play a critical role in assuring product quality. NRAs are responsible for the review of licensing applications, lot release, and monitoring the performance of the product in their country. The scientific competence and harmonized practices of NRAs have become essential components of the quality assurance of products moving in international trade.

As part of its program of biological standardization, WHO documents the current regulatory practices for both general and product-specific topics to support national regulatory authorities and manufacturers so that the quality of all vaccines is of assured quality.