In the biotech industry, process validation is a crucial step in ensuring the quality, consistency, and reliability of manufacturing processes, particularly for pharmaceuticals, biologics, and other biological products.Process validation occurs after process characterization and typically prior to commercial production. Its main objective is to demonstrate that the manufacturing process, as characterized, consistently produces product meeting predetermined quality requirements.
Process validation involves executing the manufacturing process under routine conditions to generate data that confirm the process’s ability to consistently produce acceptable product quality.
Three stages of process validation are commonly recognized:
- Stage 1 – Process Design: Establishes process design parameters based on knowledge gained from process characterization.
- Stage 2 – Process Qualification: Demonstrates the consistency and reproducibility of the process at scale through a series of runs under normal operating conditions. The runs are referred to as Process Performance Qualification (PPQ) runs, and it is assumed that three PPQ batches is sufficient to demonstrate reproducibility of the process performance.
- Stage 3 – Continued Process Verification: Ongoing monitoring and assessment of the manufacturing process to ensure it remains in a state of control during routine production.
Process validation is typically conducted in accordance with regulatory guidelines (e.g., FDA, EMA) and involves documentation of protocols, execution of validation runs, and analysis of data to demonstrate process robustness and reliability.