Hold time study result

Quality Assurance
1

If batch is released from QC however 72 hours result of hold time it indicate that batch is fail in Description then what should be done kindly suggest

2

1-If batch is released from QC however 72 hours result of hold time it indicate that batch is fail in Description then what should be done kindly suggest.
Answer-
Please provide further details about the “Failing in description” of the batch.
Please correlate your 72-hour result of the description with the established Hold time of this product. If 72-hr is beyond established hold time then it will be a deviation and should be investigated. What is the impact of 72-hr hold time on other quality parameters as per finished product specification?
Before the decision about the release /rejection of this batch is taken by QA, you must know the investigation outcome and root cause. If the 72-hr hold time is within the established hold time then you must find out the reason for the failure of the ‘Description’ test. Based on the investigation outcome, a CAPA should be established.

2 Likes
3

Thank you so much sir

4

You are always welcome.

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