Area clearance during batch/product change over in Pilot Production facility. Quality Assurance
- OBJECTIVE :
- To provide procedure for Area clearance during batch/product change over in Pilot Production facility.
- RESPONSIBILITY :
- Officer Quality Assurance for implementation
- Quality Assurance Manager to ensure compliance.
- PROCEDURE :
- Note:
- (i) Type-A Area clearance :
- During batch change over of same product.
- (ii) Type-B Area clearance :
- During batch change over of same product with different strength.
- (iii)Type-C Area clearance :
- During product change over and before bio-batch.
- Area clearance – Type A/B :
- Check that area is cleaned as per Type A / Type B cleaning procedure and ‘AREA CLEANED’ – Type A/B board is displayed.
- Check that all equipments are cleaned and ‘EQUIPMENT CLEANED-TYPE A/B ‘ tag is displayed on each equipment.
- Ensure that the area cleaning checklist Type A/B is filled and signed by Officer – Pilot Production.
- Check that no containers of previous batch are present in process area.
- Check that no coded packing material of previous batch is present in process / packing area.
- 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.
- Fill inspection details in Area clearance Checklist – Type A/B (annexure -2).
- If found satisfactory clear the area for next batch of same product or same product with different strength.
- If found not satisfactory inform the Officer – Pilot Production to repeat the cleaning process and reinspect.
- Area clearance – Type C
- Check that area is cleaned as per Type-C cleaning procedure and ‘AREA CLEANED – TYPE C’ board is displayed.
- Check that all equipments are cleaned as per Type-C cleaning procedure and “EQUIPMENT CLEANED – TYPE C’ tag is displayed on each equipment.
- Ensure that the “Area cleaning Check list – Type C” is filled and signed by ‘Officer -Pilot Production’ .
- Check that all product storage containers are cleaned.
- Check that no previous product containers are present in process area.
- Check that no packing material of previous product is present in process and packing area.
- 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.
- Fill the inspection details in ‘Area clearance check list – Type C’ (annexure – 3)
- If found satisfactory clear the area for next product or bio-batch.
- If found not satisfactory inform the Officer-Production to repeat the cleaning process and reinspect.
- Forms and Records (Annexures)
- Specimen format of “Area Clearance Checklist – Type A/B’ – Annexure 2.
- Specimen format of “Area Clearance Checklist – Type C’ – Annexure 3.
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control
- History
Date Revision Number Reason for Revision – 00 New SOP
Annexure-1,2.
|
AREA CLEARANCE CHECK LIST – TYPE A/B |
||||||||||
| PILOT PRODUCTION FACILITY | ||||||||||
| Previous Product : | Batch No.: | |||||||||
| S.No | Location of inspection | Inspection inference of
Q.A Officer |
Signature of
Q.A Officer |
Remarks | ||||||
| 1 | Outer Corridor
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||||||||
| 2 | Change Room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||||||||
| 3 | R.M.Storage Area
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, doors. windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||||||||
| 4 | Process Area
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, Pipelines, drains, dust extraction pendents, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||||||||
| 5 | Tablet compression room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, Dust extraction pendents, doors, windows etc., |
Cleaning – Satisfactory /
Not satisfactory |
||||||||
| 6 | Capsule filling room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, doors, windows, etc.,. |
Cleaning – Satisfactory /
Not satisfactory |
||||||||
| 7 | Packaging room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, Pipelines, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||||||||
| 8 | Film coating room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, Pipelines, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||||||||
| 9 | Washing room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, Pipelines, drains, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||||||||
| GENERAL INSPECTION | ||||||||||
| 10 | No product containers of previous
batch observed in process area. |
Yes / No | ||||||||
| 11 | No coded packing material of previous batch is present in process / packing area. | Yes / No | ||||||||
| 12 | No visible extraneous matter or powder is observed in Pilot Production area. | Yes / No | ||||||||
| 13 | Equipments cleaned and Equipment cleaned-Type A/B’ tag displayed. | Yes / No | ||||||||
| 14 | Area cleaning checklist-Type A/B
filled and signed by Officer Pilot Production. |
Yes / No | ||||||||
Annexure-3
| AREA CLEARANCE CHECK LIST – TYPE C | ||||
| PILOT PRODUCTION FACILITY | ||||
| Previous Product : |
Inspection inference of Q.A Officer |
Batch No.: | ||
| S.No | Location of inspection | Signature of
Q.A Officer |
||
| 1 | Outer Corridor
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||
| 2 | Change Room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||
| 3 | R.M.Storage Area
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, doors. windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||
| 4 | Process Area
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, Pipelines, drains, dust extraction pendents, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||
| 5 | Tablet compression room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, out side of Dust extraction pendents, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||
| 6 | Capsule filling room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||
| 7 | Packaging room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filter, Pipelines, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||
| 8 | Film coating room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, Pipelines, drains, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||
| 9 | Washing room
Floor, wall, ceiling, R.A Filter/box, Grills of HEPA filters, Pipelines, drains, doors, windows, etc., |
Cleaning – Satisfactory /
Not satisfactory |
||
| GENERAL INSPECTION | ||||
| 10 | No product containers of previous
product observed in process area. |
Yes / No | ||
| 11 | Empty product storage containers are found cleaned. | Yes / No | ||
| 12 | No packing material of previous product found. | Yes / No | ||
| 13 | No visible extraneous matter or powder is observed in Pilot
Production area. |
Yes / No | ||
| 14 | Equipment cleaned and ‘Equipment cleaned-Type
C’ tag displayed. |
Yes / No | ||
| 15 | Area cleaning checklist-Type C
filled and signed by Officer Pilot Production. |
Yes / No | ||
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