Cleaning validation and cleaning verification are both crucial processes in manufacturing, particularly in the pharmaceutical and medical device industries, but they serve distinct purposes. The main difference lies in their scope and timing. Validation confirms the effectiveness of cleaning methods from the start, while verification ensures these validated methods are consistently applied correctly.
Here's a detailed breakdown:
Cleaning Validation vs. Cleaning Verification
| Feature | Cleaning Validation | Cleaning Verification |
|---|---|---|
| Purpose | To prove that a cleaning procedure consistently removes residues and contaminants to an acceptable level. | To confirm that the validated cleaning procedure is being implemented correctly and consistently in routine operations. |
| Timing | Conducted before routine manufacturing begins or when significant changes are made to the cleaning process. | Conducted regularly during routine manufacturing operations. |
| Focus | Establishing the effectiveness of the cleaning method itself. | Ensuring proper execution of the validated cleaning method. |
| Outcome | A validated cleaning process that is proven to be effective. | Evidence that the cleaning process is consistently performing as expected. |
Key Differences Explained
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Validation: Proving it Works Cleaning validation establishes documented evidence that a cleaning process will consistently remove residues to predetermined acceptable limits. According to our reference, "Validation is confirming that the most effective cleaning methods are instituted from the beginning." This involves:
- Defining the equipment and products involved.
- Establishing acceptable residue limits (e.g., based on toxicity).
- Developing a detailed cleaning procedure.
- Conducting multiple cleaning cycles (typically three) and testing the results.
- Documenting all findings in a validation report.
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Verification: Confirming Consistent Application Cleaning verification provides evidence that the validated cleaning procedure is being implemented as intended during routine production. Our reference states, "Verification is ensuring validated cleaning methods are being properly implemented." This might include:
- Periodic testing of cleaned equipment.
- Regular audits of cleaning procedures and documentation.
- Training and qualification of cleaning personnel.
- Review of cleaning records for completeness and accuracy.
Examples
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Validation Example: A pharmaceutical company is introducing a new drug product. Before manufacturing commences, they must validate the cleaning procedure for the equipment used to manufacture this new product. This validation will prove that the cleaning process removes all traces of the drug and cleaning agents to acceptable levels, ensuring no cross-contamination with subsequent products.
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Verification Example: After validating the cleaning procedure (as above), the company routinely performs swabbing of the equipment after cleaning to confirm that residues remain below the established limits. This ongoing verification confirms that the validated cleaning process continues to be effectively implemented.
In summary, cleaning validation is about proving that a cleaning process can work, while cleaning verification is about showing that the process is working consistently in practice. Both are necessary to maintain product quality and patient safety.
