Stability and traceability requirements for vaccine intermediates - Scientific guideline

This document reflects the need for the development of a common approach to traceability and stability requirements for vaccine intermediates.

EMA has decided not to progress this concept paper as the following guidelines appropriately address this subject:

• Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission
• ICH Q5C Stability testing of biotechnological/biological products

Keywords: Vaccine, stability, traceability, sourcing, cumulative stability, combined vaccines, holding times

Current version

Concept paper on the development of a committee for proprietary medicinal products (CPMP) points to consider on stability and traceability requirements for vaccine intermediates

Reference Number: CPMP/BWP/4310/00