HOLD TIME STUDY
HOLD TIME STUDY :
Why Three consecutive batches taken for Validation
Consecutive meaning following closely with no gap or following one after another without interruption. The number of batches to be taken under validation depends upon the risk involved in the manufacturing Critical process parameters & critical Quality Attribute so depends upon that manufacturer have to choose the number of batches to be validated. If we will consider less than two batches then the data will not be sufficient for evaluation of and to prove reproducibility of data between batch to batch variation & if we consider more than three batches it can increase the time & cost of manufacturer which usually not preferred. Generally if we will require quality in the First batch, then it is accidental (co-incidental), Second batch quality is regular & third batch quality is Validation or Confirmation. Statistical evaluation cannot be done by considering two points, because two points always draw a straight line so minimum three points requir...
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