The vaccine itself, as released, must meet standards for identity, purity, potency, safety, efficacy,
stability, and consistency. The vaccine manufacturing process, as regulated, must meet standards for
• source and quality of the starting materials, especially when of human or animal origin
• characterization of the cellular substrate for growth, including considerations of identity, origin, passage
history, adventitious agents, endogenous agents, and tumorigenicity
• characterization of seed stocks, again considering identity, origin, and adventitious agents
• validation for inactivation or removal of adventitious agents
• in-process testing with defined specifications and standard operating procedures
• release testing of both bulk and finished product for defined specifications
• stability studies to define the shelf life of the product.