SOP For Process Area clearance during batch/product changeover
OBJECTIVE :
To provide a procedure for Process area clearance during batch/product changeover.
RESPONSIBILITY :
Officer Quality Assurance for implementation Head of Quality Assurance Department to ensure compliance.
PROCEDURE :
Note:
Type-A Area clearance :
During the batch changeover of the same product.
Type-B Area clearance :
During the batch changeover of the same product with different strengths.
Type-C Area clearance :
During product changeover and before taking bio-batch.
Area clearance – Type A/B :
Officer – QA shall check and ensure that
The area is cleaned as per the Type A / Type B cleaning procedure and the ‘AREA CLEANED’ – Type A/B board is displayed.
All equipment is cleaned and displayed on each piece of equipment.
The daily cleaning details are entered in the daily cleaning register for Production areas.
Check that the details of equipment cleaning are entered into individual equipment cleaning log books.
The area cleaning checklist Type A/B is filled and signed by Officer-Production and filed in the respective Batch Production Record.
No containers of the previous batch are present in the process area.
If any containers of the previous batch are present, ensure that each container is properly sealed, labeled, and stored in the storage room.
Officer – QA shall fill inspection details in the Area clearance Checklist – Type A/B (Annexure -2).
If found satisfactory clear the area for the next batch of the same product or the same product with different strengths.
If found not satisfactory inform Officer – Production to repeat the cleaning process and reinspect.
Area clearance – Type C
Officer – QA shall check and ensure that
The area is cleaned as per the Type-C cleaning procedure and the ‘AREA CLEANED – TYPE C’ board is displayed.
All equipment is cleaned as per the Type-C cleaning procedure and the “EQUIPMENT CLEANED – TYPE C’ tag (annexure -1) is displayed on each piece of equipment.
The daily cleaning details are entered in the Daily Cleaning register for Production areas.
The cleaning details are entered into individual equipment cleaning log books.
The “Area cleaning Checklist – Type C” is filled and signed by Officer – Production and filed in the respective Batch Production record.
All product storage containers are cleaned.
No previous product containers are present in the process area.
The floor, wall, ceiling, return air boxes/filters, grills of HEPA filters, service lines, electrical fixtures, drains, windows, doors, etc. are free from visible extraneous matter.
The return air prefilters are cleaned and the cleaning details are entered in the Filter cleaning log.
The details of drain sanitation are entered in the drain sanitation log.
Officer – QA shall fill the inspection details in the ‘Area clearance checklist – Type C’ (annexure – 3)
If found satisfactory clear the area for a batch of the next product.
If found not satisfactory inform Officer-Production to repeat the cleaning process and reinspect.
Forms and Records (Annexures)
Specimen format of “Area Clearance Checklist – Type A/B for Production TA/TB/TC’
Specimen format of “Area Clearance Checklist – Type C for Production
Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control. engineering
History
| Date | Revision Number | Reason for Revision |
| – | 00 | New SOP |
Area Clearance Checklist – Type A/B for Production TA/TB/TC’
Previous Product: ___________ Batch No.:___________
Checklist and tick remark – Cleaning – Satisfactory /not satisfactory
Outer Corridor
Floor, walls, ceiling, diffuser frames (R.A & S.A), doors, windows, and light fixtures.
Change Room
Floor, walls, ceiling, diffuser frames (R.A & S.A), light fixtures.
Material Storage Area
Floor, walls, ceiling, doors, windows, Dust extraction pipe, diffusers (R.A & S.A), light fixtures.
Washing room
Floor, walls, ceiling, steam, compressed air & water lines, drain, diffusers (R.A & S.A), light fixtures.
Inner corridors :
Floor, walls, windows, doors, Grills of HEPA filters, RA filters, RA filter housing, and light fixtures.
Cleaned Equipment Storage room:
Floor, walls, windows, door, Grills of HEPA filters, RA filters, RA filter housing, and light fixtures.
Sifting room :
Floor, walls, windows, door, Grills of HEPA filters, Compressed air line, DE pipe, RA filters, RA housing, and light fixtures.
Granulation room :
Floor, walls, windows, door, Grills of HEPA filters, RA filters, RAF housing, DE pipes, steam, compressed air, water lines, and light fixtures.
Granule storage room :
Floor, walls, windows, door, Grills HEPA filters, RA filters, RA Filter housing, light fixtures.
Compression room :
Floor, walls, ceiling, windows, door, DES pipe, compressed air pipeline, Grills of HEPA filter, RA filter, RA filter housing, and light fixtures.
Compressed and/or coated tablets
storage room :
Floor, walls, ceiling, windows, door, Grills of HEPA filters, RA filter, RA filter housing, and light fixtures.
Spare room :
Floor, walls, ceiling, windows, door, Grills of HEPA filters, RA filter, RA filter housing, and light fixtures.
Tablet Inspection room :
Floor, walls, ceiling, windows, Grills of HEPA filters, RA filter, RA filter housing, and light fixtures.
Coating room :
Floor, walls, ceiling, windows, door, Grills of HEPA filters, RA filter, RA filter housing, steam, compressed air, water lines, and light fixtures.
No product containers of previous products were observed in the process area.
Any container of other products is appropriately sealed & labeled.
Empty product storage containers are found clean.
No packing material for the previous product was found.
No visible extraneous matter or powder is observed in the facility.
Equipment cleaned and ‘Equipment cleaned-Type-A/B’ tag displayed.
Area cleaning checklist-Type A/B filled and signed by Officer Production.
Pre-filter cleaning entered in the ‘Filter cleaning log’
Daily cleaning details of the area and cleaning and sanitation of drain points entered in respective logs
Specimen format of “Area Clearance Checklist – Type C for Production TA/TB/TC’
Previous Product:____________________ Batch No.:__________________________
Location of inspection
Outer Corridor
Floor, walls, ceiling, diffuser frames (R.A & S.A), doors, windows, and light fixtures.
Change Room
Floor, walls, ceiling, diffuser frames (R.A & S.A), light fixtures.
Material Storage Area
Floor, walls, ceiling, doors, windows, Dust extraction pipe, diffusers (R.A & S.A), light fixtures.
Washing room
Floor, walls, ceiling, steam, compressed air & water lines, drain, diffusers (R.A & S.A), light fixtures.
Inner corridors :
Floor, walls, windows, doors, Grills of HEPA filters, RA filters, RA filter housing, and light fixtures.
Cleaned Equipment Storage room:
Floor, walls, windows, door, Grills of HEPA filters, RA filters, RA filter housing, and light fixtures.
Sifting room :
Floor, walls, windows, door, Grills of HEPA filters, Compressed air line, DE pipe, RA filters, RA housing, drain pit, and light fixtures.
Granulation room :
Floor, walls, windows, door, Grills of HEPA filters, RA filters, RAF housing, DE pipes, steam,
compressed air, water lines, drain pit, and light fixtures.
Granule storage room :
Floor, walls, windows, door, Grills HEPA filters, RA filters, RA Filter housing, light fixtures.
Compression room :
Floor, walls, ceiling, windows, door, DES pipe, compressed air pipeline, Grills of HEPA filter,
RA filter, RA filter housing, and light fixtures.
Compressed and/or coated tablets
storage room :
Floor, walls, ceiling, windows, door, Grills of HEPA filters, RA filter, RA filter housing, and light fixtures.
Spare room :
Floor, walls, ceiling, windows, door, Grills of HEPA filters, RA filter, RA filter housing, and light fixtures.
Tablet Inspection room :
Floor, walls, ceiling, windows, Grills of HEPA filters, RA filter, RA filter housing, and light fixtures.
Coating room :
Floor, walls, ceiling, windows, door, Grills of HEPA filters, RA filter, RA filter housing, steam, compressed air, drain pit, water lines, and light fixtures.
Secondary gowning of previous product removed.
No product containers of previous products were observed in the process area.
Any container of other products is appropriately sealed & labeled.
Empty product storage containers are found clean.
No packing material for the previous product was found.
No visible extraneous matter or powder is observed in the facility.
Equipment cleaned and ‘Equipment cleaned-Type C’ tag displayed.
Area cleaning checklist-Type C filled and signed by Officer Production.
Pre-filter cleaning entered in the ‘Filter cleaning log’
Daily cleaning details and cleaning and sanitation of drain points entered in respective logs