The approach to validation has evolved over the years. The idea of relying entirely on the analysis of three pre-market validation batches was not sufficient to guarantee the effectiveness and quality of the process and has been abandoned.
On the contrary, it is now generally accepted that validation is a continuous process throughout a product's life-cycle even after it has been placed on the market.
Validation as a “Life Cycle Process” includes 3 main stages:
- Stage 1: Process Design
- Stage 2: Process Qualification/ Demonstration
- Stage 3: Continued Process Verification
Where stage 2, which corresponded to the old validation approach, represents now only a small part of the entire process.
This workshop aims to provide insights into this continuous validation approach, describing how these new requirements can be achieved, according to and fitting both FDA and European guidelines.
The course will address and discuss how to demonstrate sound knowledge and understanding of the process based on the studies carried out in the development phase, which parameters to be used, when a process can be considered validated and how “ongoing process verification” can be realized.