Validating Multicolumn Distillation PLant

GOOD DOCUMENTATION PRACTICE (GDocP) PQ (PERFORMANCE QUALIFICATION)
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  • For a new Multicolumn Distillation Plant recently purchased I have completed IQ/OQ. Do i need to perform a PQ following phase-1,Phase-2 each of 14-28 days. Or a PQ of 3-4 days would suffice the same.
  • The same Question goes for Pure Steam Generator. Do we need to PQ for the PS condensate extensively for phase-1 & 2 or 3-4 days would suffice the PQ requirement.
  • What is the usual practice in the industry ?
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    Dear sir,

    You should monitor the product (WFI) in Phase-I (at least 21 days), Phase-II (at least 21 days) and Phase-III (1 year) against standard specification.

    Thanks with Regards,
    Sitarama Raju