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
