Process Validation of Existing Processes and Systems Using Statistically ..Part2

A Statistically Valid Time Frame or Number of BatchesHow large of a sample set is needed of previously recorded data to determine ranges that are truly representative of the process, and will the ranges be useful in the Validation effort and not set o­ne up for failure? This is a difficult question to answer, and it is important to note that the batches selected should have no changes between them, thus be produced with the same processing conditions. The draft FDA Guidance for Industry, Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients from March of 1998 suggests that 10-30 consecutive batches be examined to assess process consistency.


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