SOP on Decartoning of Vials.

  • Objective:
  • To lay down a procedure for Decartoning of Vials.
  • Scope
  • This SOP is applicable for Decartoning of vials.
  • Responsibility
  • Production officer / Executive.
  • Accountability
  • Production Head and Head QA shall be accountable for the compliance of SOP.
  • Abbreviations
  • Not Applicable
  • Procedure
    • Get the vials issued as per the batch requisition slip from warehouse and verify the quantity and analytical report number.
    • Dedust the shipper of vials using a lint free cloth in decartoning room.
    • Cut and remove the outer poly bag of the shipper, clean the shipper with lint free cloth in the vial decartoning room.
    • Keep the shipper on the loading station. Open the box from topside.
    • Activate the pneumatic mechanism such that the platform is raised slightly above the level of the inspection station.
    • Transfer the vials manually by pushing with the stainless steel plate to the inspection station.
    • Inspect the vials for any defects like, Moulding, Vial neck, Crack/Broken defects, and Black and Brown spot. and keep the defective vials in the rejected trays.
    • Push the good inspected vials in to the plastic tray and load these vials in vial washing machine.
    • Count the rejected vials and enter the rejected vials in Batch Production Record.
    • Record the operation details in Batch production record.
    • Forms and Records (Annexures)
    • Not Applicable
    • Distribution
    • Master copy –   Quality Assurance
    • Controlled copies- Quality Assurance, Production
    • History
      Date Revision Number
      Reason for Revision
      00 New SOP

 

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