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Why 3X samples collected in process validation?

Answers were Sorted based on User's Feedback



Why 3X samples collected in process validation?..

Answer / vilas alte

To get the idea on the process capability that whether the
intended process gives the consistent results or not
(precision).

Is This Answer Correct ?    24 Yes 4 No

Why 3X samples collected in process validation?..

Answer / suraj raj

3x sampling is done in process validation because if sample 1 fails and in repeat analysis if sample 2 passes in such case to confirm the results you need 3rd sample to confirm the result.

Is This Answer Correct ?    3 Yes 0 No

Why 3X samples collected in process validation?..

Answer / chaitanya patha

1 for QA , 2 for QC , 3 for Future reference in case of any
problem that may arise with the batch after its release into
market.

Is This Answer Correct ?    12 Yes 15 No

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