Packaging Area/Line Clearance during batch/product change over

• OBJECTIVE :
• To outline the procedure for the Packaging Area/Line clearance before the start up of any packaging operation, to ensure that the packaging area/line has been thoroughly  cleaned  and  that  all  coded labeling   and   packaging  materials of the previous batch/product have been completely removed.
• RESPONSIBILITY :
• Officer – Production  Packaging
• Officer – Quality Assurance
• Head – Production Department
• Head – Quality Assurance Department to ensure compliance
• PROCEDURE :
• Note:
• 1. Type-A Area clearance : During batch change over of same product.
• 2. Type-B Area clearance : During batch change over of same product  with different strength.
• 3. Type-C Area clearance : During product change over and before bio-batch.
• Packaging Line Clearance – Type A / B
• QA Officer shall ensure that :
• The area is cleaned as per Type A / Type B cleaning procedure and ‘AREA
• CLEANED’ – Type A/B board is displayed.
• All equipments are cleaned and ‘EQUIPMENT CLEANED-TYPE A/B’ tag  is displayed on each equipment.
• The Packing  Area  Cleaning Checklist  Type A/B is filled and signed by Officer- Production.
• No containers of previous batch shall be present in the packaging area.
• In case of Type -‘ A’ clearance, any excess packaging materials and uncoded labeling  of  the  previous  batch  which are suitable for next batch are suitably identified and stored.
• In case of Type -‘ B’ clearance, any excess packaging materials of  previous product are accounted and  transferred to Stores  through material return note.
• All coded labeling of previous batch are accounted  and destroyed.
• QA – Officer shall run the belt of the packaging line in empty for about two minutes, and  ensure that no tablet/capsule of previous product  is lying behind the belt.
• Details of operation to be taken up on the Packing Line is displayed on a board.
• The environmental  conditions in the Primary  packaging area are  within  that specified, if  any,  in the Batch Production Record.
• The documents in the Batch Production  Record are completed upto the previous operational stage.
• Officer- QA  shall  enter  the details of inspection in the Packaging Area/ Line Clearance Checklist  – Type – A (Annexure -2) and  Type – B (Annexure – 3).
• If  found  satisfactory, Officer – QA  shall  clear  the  Area for the packaging of next batch of same product (Type -A)  or  same  product   with  different strength (Type B) and remove the ‘Area cleaned – Type B’ board.
• If  found unsatisfactory,  Officer – QA  shall  inform the  Officer – Production Packaging to repeat the cleaning process and reinspect.
• The required packing materials (printed and unprinted) and the product to be packed shall be transferred to the packaging area only after clearance by Officer – QA.
• Packaging Line Clearance – Type C
• QA Officer shall ensure that :
• The Packaging Area  is cleaned as per Type – C  Cleaning procedure and ‘AREA  CLEANED  – TYPE C’  board  is displayed.
• All equipments are cleaned as per Type-B or Type-C cleaning procedure as applicable and “EQUIPMENT CLEANED -TYPE B/C ”  tag  is displayed on the equipment.
• The Packaging Area Cleaning Checklist  –  Type  C  is  filled and signed  by Officer –  Production  Packaging.
• No containers  of previous  batch shall  be present  in the  packaging  area.
• All coded labeling of previous product  are accounted and destroyed.
• All uncoded  labeling and packaging materials of previous product are completely  removed  from the packaging  area and returned to stores through material return note.
• The inspection  tables are clear  and completely free  from  the previous product.
• QA – Officer shall run the belt of the packaging line in empty for about two minutes, and ensure that no tablet/capsule of previous product  is lying behind the belt.
• The documents in the Batch Production Record (BPR) are completed upto the last operational stage
• Details of operation to be taken up on the packing Line is displayed on a board.
• The environmental  conditions in the Primary  packaging area are  within  that  specified, if  any,  in the Batch Production Record.
• Inspect  floor, wall,  ceiling, return air boxes, filters,  grills of  HEPA  filters, electrical fixtures,  drains,  windows,  doors,  etc.  to be  free  from  visible extraneous matter in the primary packaging area.
• Officer – QA shall enter the details of inspection in the Packaging Line Clearance Checklist (annexure-4)
• If  the  Packaging  Line  is  found  satisfactorily cleaned Officer – QA shall clear the line for next product by entering the same on the Packaging Line Clearance
• Checklist  Type  C and remove the ‘Area Cleaned – Type C’ board.
• If found unsatisfactory, Officer QA shall inform the same to Incharge – Production Packaging about the observed discrepancies and reinspect after rectification.
• The required  packaging materials ( printed and unprinted) and the product to be packed  shall  be  transferred  to the  Packaging  Area  only after  the Area and line  is cleared  by Officer – QA.

• Forms and Records (Annexures)
• Specimen  format  of  “Packaging  Line  Clearance  Checklist – Type  A”- Annexure 2.
• Specimen  format  of  “Packaging  Line  Clearance  Checklist – Type B”- Annexure 3.
• Specimen format of “Packaging Line Clearance Checklist -Type C” Annexure 4.

• Distribution
• Master copy –  Quality Assurance
• Controlled copies- Quality Assurance, Production, Quality Control.engineering
• History
  

  Date	Revision Number	Reason for Revision
  –	00	New SOP

Annexure-2.

Annexure-3

Annexure-4

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