SOP for delabelling and repacking of vials

December 19, 2019March 1, 2024 Pharma Editor

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.

TRIMETHOPRIM AND SULPHAMETHOXAZOLE TABLETS

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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