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Assigning of repack before date

  • OBJECTIVE :
  • To lay down the procedure for assigning of ‘repack before date’.
  • RESPONSIBILITY :
  • Officer  Production/Officer Quality Assurance
  • Head – Quality Assurance to ensure compliance.
  • PROCEDURE
  • The ‘repack before date’ shall be assigned from the day packing is initiated.
  • The basis for period of repack before shall be on the approval given by FDA.
  • The period of repack before shall be mentioned in the respective Master Production Records.
  • When the ‘repack  before date’ is 3 months :
  • If the date packing initiated is 15 August, 2017, then the repack before date shall be 14 November, 2017.
  • If the date packing initiated is 1 September, 2017, then the repack before date shall be 30 November, 2017.
  • When the ‘repack  before date’ is 6 months :
  • If the date packing initiated is 15 August, 2017, then the repack before date shall be  14 February, 2017.
  • The date shall be in the form of DD/MM/YY.
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control.engineering
  • History
    Date Revision Number Reason for Revision
    00 New SOP

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