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.
(a) When the ‘repack before date’ is 3 months :
(i) If the date packing initiated is 15 August, 2020, then the repack before date shall be 14 November, 2020.
(ii) If the date packing initiated is 1 September, 2020, then the repack before date shall be 30 November, 2020.
(b) When the ‘repack before date’ is 6 months :
(i) If the date packing initiated is 15 August, 2020, then the repack before date shall be 14 February, 2021.
The date shall be in the form of DD/MM/YY.