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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
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00
New SOP
Post Views: 92
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