SOP For Assigning of repacking before date

January 18, 2017September 11, 2023 Pharma Editor

SOP For Assigning repacking before the date

OBJECTIVE :

To lay down the procedure for assigning ‘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 a period of repacking before shall be the approval given by FDA.

The period of repacking 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 2023, then the repack before the date shall be 14 November 2023.

If the date packing initiated is 1 September 2023, then the repack before the date shall be 30 November 2023.

When the ‘repack before date’ is 6 months :

If the date packing initiated is 15 August 2023, then the repack before the date shall be 14 February 2023.

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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