Cleaning validation is a regulatory requirement in pharmaceutical industry. It ensures that the cleaning process can removes the API residue from machine or equipment and make ready for next product. In this article we discuss about good cleaning validation practice in pharmaceutical industry.
1. Define the scope of the cleaning validation study
Determine which equipment, surfaces, and processes will be included in the study.
2. Develop a cleaning validation protocol
Create a detailed plan that outlines the objectives, acceptance criteria, sampling methods, analytical procedures, and documentation requirements for the cleaning validation study.
3. Conduct a risk assessment
Identify potential risks associated with inadequate cleaning and prioritize them based on severity and likelihood of occurrence.
4. Select worst-case scenarios
Choose the most challenging or representative equipment or surfaces to validate the cleaning process.
5. Establish acceptance criteria
Set specific limits for residual levels of contaminants that are considered acceptable after cleaning.
6. Develop a sampling plan
Determine how and where samples will be collected during the validation study to ensure representative data.
7. Execute cleaning procedures
Perform multiple consecutive cleaning cycles using validated procedures to ensure consistent results.
8. Collect samples
Take swab or rinse samples from critical areas to measure residual levels of contaminants.
9. Analyze samples
Use appropriate analytical methods to quantify residual levels of contaminants in the collected samples.
10. Evaluate results
Compare the measured residual levels against established acceptance criteria to determine if the cleaning process is effective.
11. Document results and conclusions
Record all data , observations, and conclusions from the cleaning validation study in a comprehensive report.
12. Implement corrective actions if necessary
If any deviations or failures are identified during the validation study, take appropriate actions to address them and improve the cleaning process.
13. Maintain ongoing monitoring and verification:
Regularly monitor and verify that the established cleaning procedures continue to effectively remove contaminants from equipment or surfaces by conducting periodic revalidation studies or routine testing.
14. Review and update as needed
Periodically review and update the cleaning validation protocol based on changes in equipment, processes, regulations, or industry best practices to ensure continued compliance with standards and guidelines.
Read also:
Post a Comment