Great information thank you. Is the expectation to perform a health based calculation for dedicated enclosed equipment? The product does not have any degradants.
@helenanunan It depends on the type of potential impurities that could have an impact on health. A detailed risk assessment (ICHQ9) helps to justify if there are no potential health hazards possible. Data should support this justification.
@@pharmaworldk1473 thanks for your response. A risk assessment has been completed and there are no impurities of concern. It is still a requirement to perform cleaning val to establish dirty and clean equipment hold times for low risk dedicated equipment? What are your thoughts? Thanks
@helenanunan A comprehensive cleaning validation protocol may be made with a clear aim on the cleaning validation with reference to the results obtained by the risk assessment report. In conclusion, the data may be evaluated statistically and reviewed. An assertive statement that there is no requirement to carry out individual cleaning validation may be made. Regulators may accept this statement. The data should be comprehensive, and there are no loose ends unanswered.
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@@kkuppuluri Thank you
Great information thank you. Is the expectation to perform a health based calculation for dedicated enclosed equipment? The product does not have any degradants.
@helenanunan It depends on the type of potential impurities that could have an impact on health. A detailed risk assessment (ICHQ9) helps to justify if there are no potential health hazards possible. Data should support this justification.
@@pharmaworldk1473 thanks for your response. A risk assessment has been completed and there are no impurities of concern. It is still a requirement to perform cleaning val to establish dirty and clean equipment hold times for low risk dedicated equipment? What are your thoughts? Thanks
@helenanunan A comprehensive cleaning validation protocol may be made with a clear aim on the cleaning validation with reference to the results obtained by the risk assessment report. In conclusion, the data may be evaluated statistically and reviewed. An assertive statement that there is no requirement to carry out individual cleaning validation may be made. Regulators may accept this statement. The data should be comprehensive, and there are no loose ends unanswered.