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SOP for delabelling and repacking of vials

  • Objective:
  • To lay down a procedure for Delabelling and Repacking of vials.
  • Scope
  • This SOP is applicable on procedure for Delabelling and Repacking of vials for Production dry powder Injection facility.
  • Responsibility
  • Production Officers / Executive.
  • Accountability
  • Production Head shall be accountable for the compliance of SOP.
  • Abbreviations
  • SOP : Standard Operating Procedure.
  • Procedure
  • Delabelling of vials:
  • Place the vials to be delabelled in the plastic trays/stainless steel trays.
  • Wear hand gloves and fill the tray with Ethyl Acetate just sufficient to dip the vials up to neck and keep the vials soaked in Ethyl Acetate solvent for 10-15 minutes.
  • Note: Ensure that Ethyl Acetate does not touch the vials seals.
  • Take out the vials from tray and remove the loosened labels from vials manually.
  • Destroy the labels after removed from vials.
  • Clean the delabelled vials with a wet lint free wipe followed by the wiping with lint free wipe.
  • Keep delabelled vials in identified trays.
  • Get the delabelled vials after checking from the in-process quality control / production officer.
  • Recheck and relabel the delabelled vials under same batch.
  • Pack the relabelled vials.
  • Repacking of vials:
  • Take clearance for repacking of vials from the in-process quality control as per fresh marketing requirement.
  • Receive the material for repacking.
  • Open the shipper box and recover the labelled vials, pack inserts, unit cartons for further rework.
  • Delabel the vials as per the procedure of delabelling of vials.
  • Destroy the delabelled labels, unit cartons, pack inserts and shipper boxes and dispose off as per SOP.
  • After getting approval from the in-process quality assurance officer.
  • Take the sticker labels, unit cartons, pack inserts and shipper boxes from the production officer as per the secondary packing material requisition.
  • Relabel the delabelled vials under same batch.
  • Pack the re-label vials under the same batch.
  • Transfer the packed material to the Finished goods store.
  • Get the release note from in-process quality control and transfer the packed material to Finished Goods store room through material transfer note for further despatch and distribution.
  • Maintain all records for repacking and enter in Batch Production Record.
  • Forms and Records (Annexures)
  • Not Applicable
  • Distribution
  • Master copy –  Quality Assurance
  • Controlled copies- Quality Assurance, Production, Quality Control
  • History
    Date Revision Number
    Reason for Revision
    00 New SOP

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