- 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 : | ||||
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