Steps to be Validated in Process Validation

In process validation, it is crucial to monitor and scrutinize all steps that are considered critical to ensure product quality and consistency.
This includes both medium and high-risk steps which have the potential to affect the final product significantly.
Critical Steps Monitoring:
- All critical steps should be thoroughly documented, with an emphasis on understanding the relationship between the process parameters and the final product quality.
- This includes defining critical process parameters (CPPs) and critical quality attributes (CQAs) for each step to ensure they are well-understood and controlled throughout the manufacturing process.
- Detailed summaries of actual process parameters applied and observations recorded during each critical stage are essential:
  - Sifting Stage
  - Granulation Stages (Wet & Dry)
Sampling and Testing:
- Where feasible, comprehensive sampling and testing should be performed to ascertain the effectiveness and consistency of each stage.
- This must include designing appropriate sampling plans that reflect the variability expected in each manufacturing process:
  - Drying and Mixing Steps
  - Compression and Filling
  - Final Blend Characteristics: The final characteristics of the blend are considerably influenced by the outcomes of both the wet and dry granulation processes.