SOP for disposal of rejected primary and secondary packing materials

by
  • Objective:
  • To lay down a procedure for Disposal of rejected primary & secondary packing materials.
  • Scope
  • This SOP is applicable on procedure for Disposal of rejected primary & secondary packing materials for Production dry powder Injection facility.
  • Responsibility
  • Officers or above – Production.
  • Accountability
  • Production Head.
  • Abbreviations
  • SOP : Standard Operating Procedure.
  • WFI : Water for Injection.
  • Procedure
  • Disposalof Primary Packing Materials :-
  •  After completion of day’s work collect the rejected vials (Moulding defects, crack & broken vials) in a separate poly bag.
  • Count & checkthe collected vials & enter the quantity in Primary Packing Material Destruction Record in Batch Production Record.
  • Crushthe rejected vials and transfer the glass pieces in a poly bag.
  • After completion of day’s work collect the rejected rubber stoppers (Shape defects, dirty rubber stoppers) in a separate poly bag.
  • Count & checkthe collected rubber stoppers & enter the quantity in Primary Packing Material Destruction Record in Batch Production Record.
  • After completion of day’s work collect the rejected aluminum seals (Shape defects, dirty & spot) in a separate poly bag.
  • Count & checkthe collected aluminum seals & enter the quantity in Primary Packing Material Destruction Record in Batch Production Record.
  • After verification of production supervisor / officer send the rejected vials, rubber stoppers and aluminum seals to the scrap area for further destruction.
  • Disposal of Secondary Packing Materials:
  •  After completion of day’s work collect the rejected secondary packing materials (Labels, unit cartons, multi cartons, inserts (literature) & corrugated boxes) in separate poly bags.
  • Count & checkthe rejected packing materials (Labels, cartons & corrugated boxes) & enter the quantity in secondary Packing Material Destruction Record in Batch Production Record.
  • Check that all the Printed Packing Material is torn after counting.
  • Collect,countand check the rejected WFI ampoules and puncture them after checking. Record the total quantity of rejected ampoules in the secondary packing material destruction record in Batch Production Record.
  • Collect, count & check the rejected corrugated boxes and tornthem after checking. Record the total quantity of rejected corrugated boxes in the Secondary Packing Material Destruction record in Batch Production Record.
  • After verification of production supervisor / officer send the rejected Labels, cartons, inserts, corrugated boxes & ampoules to the scrap area for further destruction.
  • Sendthe empty corrugated boxes of decartoned material, rejected rubber stereos and release paper of label roll to the Scrap area for further destruction.
  • 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
Post Views: 92
error: Content is protected !!