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.

 

PACKAGING AREA / LINE CLEARANCE

CHECKLIST – TYPE A

Previous Product Batch No.
S No. Inspection details

 

Inspection Inference

of QA Officer

Signature of QA Officer Remarks
1. Area cleaned Type A board displayed.  

Yes / No

 

 

2. Packing equipments cleaned as

per Type A/B cleaning procedure.

 

 Yes / No

 

 

3.

 

Packing area cleaning checklist-

Type A filled by Officer – Production

 

 

Yes / No

 

 

 

 

4.

 

No product containers of previous

batch observed.

 

 

Yes / No

 

 

 

 

5.

 

 

All uncoded labeling and packaging

materials of previous batch are

accounted and stored.

 

 

Yes / No

 

 

 

 

 

 

 

6.

 

All the coded labeling of previous

batch accounted and destroyed.

 

 

Yes / No

 

 

 

 

7.

 

Details of operations displayed

on the board.

 

 

Yes / No

 

 

 

 

8.

 

 

Documents in the BPR are

completed upto the previous

operational stage.

 

Yes / No

 

 

 

 

 

 

 

9.

 

 

The environmental conditions in the primary packing area are within  specified limits, if any. Yes / No

 

 

 

 

 

 

 

 

10.

 

Dust bins are cleared and scrap is removed. Yes / No

 

 

 

 

 

AREA / LINE CLEARED / NOT CLEARED
QA Officer (sign) : Date :

 

Annexure-3

PACKAGING AREA / LINE CLEARANCE

CHECKLIST – TYPE B

Previous Product  Batch No.
S No. Inspection details Inspection Inference

of QA Officer

Signature of

QA Officer

Remarks
1. Area cleaned Type B board

 displayed.

 

Yes / No

   

 

2.

 

Packing equipments cleaned as per Type A/B cleaning procedure.  

Yes / No

 

 

 

 

3.

 

Packing area cleaning checklist -Type B filled by Officer – Production  

Yes / No

 

 

 

 

4.

 

No product containers of previous batch observed.  

Yes / No

 

 

 

 

5.

 

 

All uncoded labeling and packaging materials of previous batch are accounted and returned to stores.  

 

Yes / No

 

 

 

 

 

 

 

6.

 

All the coded labeling of previous batch accounted and destroyed.  

 

Yes / No

 

 

 

 

7.

 

No tablets/capsules of previous product found behind the belt.  

Yes / No

 

 

 

 

8.  Details of operations displayed on the board.  

Yes / No

 

 

 

 

9.

 

 

Documents in the BPR are

completed upto the previous

operational stage.

 

Yes / No

 

 

 

 

 

 

 

10.

 

 

The environmental conditions in the primary packing area are within  specified limits, if any. Yes / No

 

 

 

 

 

 

 

 

11.

 

Dust bins are cleared and scrap is  removed. Yes / No  

 

AREA / LINE CLEARED / NOT CLEARED
QA Officer (sign) : Date :

Annexure-4

PACKAGING AREA / LINE CLEARANCE

CHECKLIST – TYPE C

Previous Product :  Batch No. :
S No. Inspection details Inspection Inference of QA Officer Signature of  QA Officer Remarks
1. Area cleaned Type C board displayed. Yes / No
2.

 

Packing equipment cleaned as

per Type B/C cleaning procedure.

 

Yes / No

 

 

 

 

3.

 

Packing area cleaning checklist

Type – C  filled by Officer -Production.

 

Yes / No

 

 

 

 

4. No product containers of previous

batch observed.

 

Yes / No

 

 

 

 

5.

 

 

All coded labeling material of

previous batch accounted  and

destroyed.

Yes / No

 

 

 

 

 

 

 

6. All  uncoded packing material of previous product removed and returned to  stores through MRN.  

Yes / No

 

 

 

 

 

 

7.

 

 

 

No coded / uncoded Packaging

material, printed / unprinted  labeling of previous batch found

on Packaging line.

 

Yes / No

 

 

 

 

 

 

 

 

 

 

8.

 

No tablets/capsules of previous

product found behind the belt.

 

Yes / No

 

 

 

 

9 Packaging line is clean and free from visible particulate matter.  

Yes / No

 

 

 

 

10.

 

Documents in the BPR are  completed upto the previous operational stage.  

Yes / No

 

 

 

 

11. Details of operations displayed

on the board.

 

Yes / No

 

 

 

 

12.

 

 

Floor, wall, ceiling,R.A Filters Filter housing, Grills of HEPA  filters, doors  are cleaned in

primary packaging area.

Yes / No

 

 

 

 

 

 

 

13.

 

 

The environmental conditions in the

primary packing area are within

specified limits, if any.

Yes / No

 

 

 

 

 

 

 

14. Dustbins are cleared and scrap removed. Yes / No
AREA / LINE CLEARED / NOT CLEARED
QA Officer (sign) : Date :

 

For More Pharma Updates Visit –https://pharmaguidances.com

 

error: Content is protected !!