full name of OOS & OOT ? Dercribe it with details ? why
this is needed in pharma industry ?
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Answer Posted / b.suresh naidu
OOS-Out of Specification. It means any result obtained out
side the pre defined specefied limit.
OOT-Out of Trend. It means any stability result that is not
within the expected trend, either in comparison with other
stability batches or with respect to previous/Initial
station results obtained during a stability study (Eg. This
may be of batch to batch, pack to pack,etc).Moreover this
is a alert message that may trigger to OOS.
Need: Since the products are human consumable, it may have
impact on the safety of the patient.
By monitoring these, there can be control on the
prodcuts process and can have continous improvement.
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