Process verification is a crucial step in ensuring a process meets its intended outcome and complies with established standards. It involves evaluating the process itself, rather than the output, to identify any potential issues or areas for improvement.
Here's an example of process verification:
Scenario: A pharmaceutical company manufactures tablets.
Process: The tablet manufacturing process involves several steps, including:
- Ingredient mixing: Weighing and blending active ingredients and excipients.
- Granulation: Combining ingredients to form granules.
- Compression: Pressing granules into tablets.
- Coating: Applying a coating to tablets for taste masking or controlled release.
- Packaging: Packing tablets into bottles or blister packs.
Verification: To verify the process, the company might:
- Review and audit the process documentation: This includes standard operating procedures (SOPs), batch records, and equipment calibration logs.
- Observe the process in action: This allows for a visual assessment of how the process is performed and whether it aligns with the documented procedures.
- Conduct process simulations: This involves using software or models to simulate the process under different conditions, helping to identify potential bottlenecks or areas for improvement.
- Analyze process data: This involves collecting data from various stages of the process, such as temperature, pressure, and weight measurements, to identify any trends or deviations.
- Perform process validation: This involves a comprehensive evaluation of the process to demonstrate its ability to consistently produce tablets that meet quality specifications.
Conclusion: By conducting process verification, the pharmaceutical company can ensure the tablet manufacturing process is robust, efficient, and compliant with regulatory requirements.
