Cleaning Validation - Key Questions and Answers - I

#validation #pharmaceutical #fda #pharma #who #qualitycontrol #quality
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This video is prepared to make all of you understand key expectations from different guidelines. For that purpose, 3 questions are identified every week and answered in line with current guidelines.
In this video, the questions answered are;
1. Is it required to evaluate the variability in residue levels during cleaning validation?
2. During cleaning validation, Do we have to wait for swab and rinse samples to be approved prior to using the equipment for production?
3. During MACO (Maximum Allowable Carry Over) calculation, Do we have to use a safety factor depending on the nature of the formulation?
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[@hitendrakumarshah3718]

Dear all, Please put your questions, suggestions in the comment section.

[@proogamerop5266]

Good evening sir. Thank you sir for your efforts

[@hitendrakumarshah3718]

Thanks. Please keep learning !!!

[@Bharatpithiyalive]

Dear sir how to calculated safety factor which evaluation test required for Cleaning validation like swab, rinse and other?

[@hitendrakumarshah3718]

The safety factor need not be calculated. We can use as it is

[@pankajbisht9028]

Wait till the micro results or wait only chemical results.

[@hitendrakumarshah3718]

You have to wait for results as per the specification. If your product is suceptible for microbes, definitely you need to wait.

[@becomebetter357]

Hello Sir ,
Could you please help me in issuing of product quality review report ; i am asking about details of machine&equipment calibration / qualification dates ,
1_ shall it be documented again in the PQR report ? Or it is enough to state that annuals plans and trackers are reviewed and i found that no deviations in it ?
2_ is it right to issue PQR for some products registered in WHO PQ ; and issue APR for others following only the local authority ; if this process described in SOP ? Or it is a deviation ?

[@hitendrakumarshah3718]

1. It should be documented again and reviewed. In case of any error/s in annaul plans or trackers, the errors can be rectified and ensured.
2. Your question is not clear. PQR needs to be prepared for all products. You can do the bracketing. It is acceptable as per the guideline.

[@SrinivasReddy-fh1og]

Yes sir

[@hitendrakumarshah3718]

Thanks