Pharmaceutical Guidance Complete Pharma Solution
- OBJECTIVE :
- To provide procedure for Process area clearance during batch/product change over.
- RESPONSIBILITY :
- Officer Quality Assurance for implementation Head of Quality Assurance Department to ensure compliance.
- PROCEDURE :
- Note:
- Type-A Area clearance :
- During batch change over of same product.
- Type-B Area clearance :
- During batch change over of same product with different strength.
- Type-C Area clearance :
- During product change over and before taking bio-batch.
- Area clearance – Type A/B :
- Officer – QA shall check and 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 displayed on each 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 previous batch are present in process area.
- If any containers of previous batch are present, ensure that each container is properly sealed, labeled and stored in storage room.
- Officer – QA shall fill inspection details in Area clearance Checklist – Type A/B (annexure -2).
- If found satisfactory clear the area for next batch of same product orsame product with different strength.
- 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 Type-C cleaning procedure and ‘AREA CLEANED – TYPE C’ board is displayed.
- All equipments are cleaned as per Type-C cleaning procedure and “EQUIPMENT CLEANED – TYPE C’ tag (annexure -1) is displayed on each 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 Check list – 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 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 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 ‘Area clearance check list – Type C’ (annexure – 3)
- If found satisfactory clear the area for a batch of 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’ – Annexure 2.
- Specimen format of “Area Clearance Checklist – Type A/B for Production CH’ – Annexure 3.
- Specimen format of “Area Clearance Checklist – Type A/B for Production CS’ – Annexure 4.
- Specimen format of “Area Clearance Checklist – Type C for Production TA/TB/TC’ – Annexure 5.
- Specimen format of “Area Clearance Checklist – Type C for Production CH’ – Annexure 6.
- Specimen format of “Area Clearance Checklist – Type C for Production CS’ – Annexure 7.
- 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
Specimen format of “Area Clearance Checklist – Type A/B for Production TA/TB/TC’
| 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, walls,ceiling, diffuser frames (R.A & S.A), doors, windows, light fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
||
| 2
|
Change Room
Floor, walls,ceiling, diffuser frames (R.A & S.A), light fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
|
|
| 3
|
Material Storage Area
Floor,walls,ceiling,doors,windows, Dust extraction pipe, diffusers (R.A & S.A), light fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
||
| 4
|
Washing room
Floor, walls, ceiling, steam, compressed air & water lines, drain, diffusers (R.A & S.A), light fixtures. |
Cleaning – Satisfactory / Not satisfactory |
||
| 5
|
Inner corridors :
Floor, walls, windows,doors, Grills of HEPA filters, RA filters, RA filter housing, light fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
||
| 6
|
Cleaned Equipment Storage room:
Floor, walls, windows,door, Grills of HEPA filters, RA filters, RA filter housing, light fixtures. |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 7
|
Sifting room :
Floor, walls, windows, door,Grills of HEPA filters, Compressed air line, DE pipe, RA filters, RA housing, light fixtures. |
Cleaning – Satisfactory / Not satisfactory
|
||
| 8
|
Granulation room :
Floor, walls, windows, door, Grills of HEPA filters, RA filters, RAF housing, DE pipes, steam, compressed air, water lines, light fixtures. |
Cleaning – Satisfactory /
Not satisfactory
|
|
|
| 9
|
Granule storage room :
Floor, walls, windows, door, Grills HEPA filters, RA filters, RA Filter housing, light fixtures. |
Cleaning – Satisfactory / Not satisfactory |
||
| 10
|
Compression room :
Floor, walls, ceiling, windows, door, DES pipe, compressed air pipeline, Grills of HEPA filter, RA filter, RA filter housing, light fixtures. |
Cleaning – Satisfactory / Not satisfactory |
||
| 11
|
Compressed and/or coated tablets
storage room : Floor, walls, ceiling, windows, door, Grills of HEPA filters, RA filter, RA filter housing, light fixtures. |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 12
|
Spare room :
Floor, walls, ceiling, windows, door, Grills of HEPA filters, RA filter, RA filter housing, light fixtures. |
Cleaning – Satisfactory / Not satisfactory
|
||
| 13
|
Tablet Inspection room :
Floor, walls, ceiling, windows, Grills of HEPA filters, RA filter, RA filter housing, light fixtures. |
Cleaning -Satisfactory /
Not satisfactory |
||
| 14
|
Coating room :
Floor, walls, ceiling, windows, door, Grills of HEPA filters, RA filter, RA filter housing,steam, compressed air, water lines, and light fixtures. |
Cleaning – Satisfactory / Not satisfactory
|
||
|
GENERAL INSPECTION |
||||
| 15
|
No product containers of previous product observed in process area. | Yes / No | ||
| 16
|
Any container of other product is
appropriately sealed & labeled. |
Yes / No |
||
| 17
|
Empty product storage containers are found cleaned. |
Yes / No |
||
| 18
|
No packing material of previous
product found. |
Yes / No |
||
| 19
|
No visible extraneous matter or
powder is observed in the facility. |
Yes / No | ||
| 20
|
Equipment cleaned and
‘Equipment cleaned-Type-A/B’ tag displayed. |
Yes / No
|
||
| 21
|
Area cleaning checklist-Type A/B
filled and signed by Officer Production. |
Yes / No
|
||
| 22
|
Pre-filter cleaning entered in
‘Filter cleaning log’ |
Yes / No |
||
| 23
|
Daily cleaning details of area and cleaning and sanitation of drain points entered in respective logs. |
Yes / No |
||
Annexure 3
Specimen format of “Area Clearance Checklist – Type A/B for Production CH’
| Previous Product : | Batch No.: | |||
| S.No.
|
Location of Inspection
|
Inspection inference of
QA Officer |
Signature of
QA Officer |
Remarks
|
| 1
|
Outer Corridor:
Floor , wall,ceiling, diffuser frames (R.A & S.A), doors, windows, light fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
||
| 2
|
Change Room:
Floor,wall,ceiling, air supply and return air grills, electrical fixtures, lockers, shoe racks, doors and windows . |
Cleaning – Satisfactory / Not satisfactory |
|
|
| 3
|
Material Hold Area :
Floor, wall, ceiling, air supply and return air grills, electrical fixtures, dust extraction pendent,doors and windows. |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 4
|
Wash Area :
Floor, wall, ceiling, air supply and return air grills, electrical fixtures,drainage pit, utility lines, doors and windows. |
Cleaning – Satisfactory /
Not satisfactory |
||
| 5
|
Equipment Hold Area :
Floor , wall,ceiling, HEPA filter grills. return air boxes and filters, equipment stands, doors and windows, electrical fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
||
| 6
|
Sifting Room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, equipments, utility lines,dust extraction pendent, doors and windows, electrical fixtures . |
Cleaning – Satisfactory /
Not satisfactory |
|
|
| 7
|
Blending Room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, equipments, utility lines , dust extraction pendent,doors and windows, electrical fixtures . |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 8
|
Spare Parts Room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, machines, equipments, utility lines , dust extraction pendent,doors and windows, electrical fixtures . |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 9
|
Blend Hold Room
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, pallets, doors and windows, electrical fixtures . |
Cleaning – Satisfactory /
Not satisfactory |
||
| 10
|
Empty Capsule Hold Room
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, pallets, doors and windows, electrical fixtures. |
Cleaning – Satisfactory / Not satisfactory |
||
| 11
|
Filled Capsule Quarantine Room:
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, pallets, doors and windows, electrical fixtures . |
Cleaning – Satisfactory / Not satisfactory |
||
| 12
|
Capsule Filling Room
Floor, wall, ceiling, HEPA filter grills, return air boxes and , filters,utility lines, dust extraction pendent,doors and windows, electrical fixtures . |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 13
|
Capsule Inspection Room
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters,utility lines, dust extraction pendent, doors and windows, electrical fixtures . |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 14
|
Coating Room:
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters,utility lines, dust extraction pendent, doors and windows, electrical fixtures . |
Cleaning – Satisfactory / Not satisfactory |
||
| 15
|
Office Room:
Floor, wall, ceiling,HEPA filter grills return air boxes and filters, windows and doors, electrical fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
||
| 16
|
Process Corridor :
Floor, wall, ceiling, HEPA filter grills ,electrical fixtures . |
Cleaning – Satisfactory /
Not satisfactory |
||
|
GENERAL INSPECTION |
||||
| 17
|
No product containers of previous
product observed in process area. |
Yes / No |
|
|
| 18
|
Any container of other product is appropriately sealed & labeled. |
Yes / No |
||
| 19
|
Empty product storage containers
are found cleaned. |
Yes / No |
|
|
| 20
|
No packing material of previous
product found . |
Yes / No |
||
| 21
|
No visible extraneous matter or
powder is observed in the facility. |
Yes / No |
|
|
| 22
|
Equipment cleaned and
‘Equipment cleaned-Type A/B’ tag displayed. |
Yes / No
|
|
|
| 23
|
Area cleaning checklist-Type A/B
filled and signed by Officer Production. |
Yes / No
|
||
| 24
|
Pre-filter cleaning entered in
‘Filter cleaning log’ |
Yes / No |
||
| 25
|
Daily cleaning details and
cleaning and sanitation of drain points entered in respective logs. |
Yes / No |
||
Annexure 4
Specimen format of “Area Clearance Checklist – Type A/B for Production CS’
| Previous Product : | Batch No.:
|
|||
| S.No.
|
Location of Inspection
|
Inference of QA Officer
|
Signature of QA Officer | Remarks
|
| 1
|
Outer Corridor:
Floor , wall,ceiling, diffuser frames (R.A & S.A), doors, windows, light fixtures. |
Cleaning – Satisfactory / Not satisfactory |
|
|
| 2
|
Change room :
Floor,wall,ceiling, air supply and return air grills, electrical fixtures, lockers, shoe racks, doors and windows. |
Cleaning – Satisfactory / Not satisfactory |
|
|
| 3
|
Material Hold area :
Floor, wall, ceiling, air supply and return air grills, electrical fixtures, dust extraction pendent,doors and windows . |
Cleaning – Satisfactory /
Not satisfactory |
|
|
| 4
|
Wash Area :
Floor, wall, ceiling, air supply and return air grills, electrical fixtures,drainage pit, utility lines, doors and windows . |
Cleaning – Satisfactory / Not satisfactory |
|
|
| 5
|
Medicament process area :
Floor, wall,ceiling,utility lines, equipment, light fixtures, HEPA filter grills, return air boxes, return air filters, drain points, doors and windows, electrical fixtures |
Cleaning – Satisfactory / Not satisfactory
|
|
|
| 6
|
Gelatin Process area :
Floor, wall, ceiling, utility lines, equipment platform, light fixtures, air supply grills, return air filters, drain points, doors and windows, electrical fixtures . |
Cleaning – Satisfactory / Not satisfactory
|
|
|
| 7
|
Encapsulation area :
Floor , wall,ceiling, HEPA filter grills. return air boxes and filters, equipment stands, doors and windows, electrical fixtures . |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 8
|
Drier room – 1 :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, doors , windows and equipment, electricla fixtures |
Cleaning – Satisfactory /
Not satisfactory |
||
| 9
|
Drier room – 2 :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, doors , windows and equipment, electricla fixtures |
Cleaning – Satisfactory / Not satisfactory |
||
| 10
|
Capsule Wash room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, equipments, utility lines , dust extraction pendents, doors and windows, electrical fixtures – |
Cleaning – Satisfactory / Not satisfactory
|
||
| 11
|
Capsule inspection room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, equipments, utility lines , dust extraction pendents, doors and windows, electrical fixtures – |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 12
|
Office room :
Floor, wall, ceiling,HEPA filter grills return air boxes and filters, windows and doors, electrical fixtures. |
Cleaning – Satisfactory / Not satisfactory
|
||
| 13
|
Capsule Quarantine :
Floors, wall, ceiling, HEPA filter grills, return air boxes and filters, pallets, doors and windows, electrical fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
||
| 14
|
Equipment room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, pallets, doors and windows,electrical fixtures . |
Cleaning – Satisfactory / Not satisfactory
|
||
| 15
|
Capsule Printing and Polishing room:
Floor, wall, ceiling, light fixtures, HEPA filter grills, return air boxes and filters, equipment, utility lines, doors and windows, electrical fixtures. |
Not satisfactory
|
||
| GENERAL INSPECTION | ||||
| 16
|
No product containers of previous
product observed in process area. |
Yes / No | ||
| 17
|
Any container of other product is appropriately sealed & labeled. |
Yes / No |
||
| 18
|
Empty product storage containers
are found cleaned. |
Yes / No | ||
| 19
|
No packing material of previous product found. |
Yes / No |
||
| 20
|
No visible extraneous matter or powder is observed in the facility. | Yes / No
|
||
| 21
|
Equipment cleaned and
‘Equipment cleaned-Type A/B’ tag displayed. |
Yes / No
|
||
| 22
|
Area cleaning checklist-Type A/B
filled and signed by Officer Production. |
Yes / No | ||
| 23
|
Pre-filter cleaning entered in
‘Filter cleaning log’ |
Yes / No |
||
| 24
|
Daily cleaning details and
cleaning and sanitation of drain points entered in respective logs. |
Yes / No |
|
|
Annexure 5
Specimen format of “Area Clearance Checklist – Type C for Production TA/TB/TC’
| 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, walls,ceiling, diffuser frames (R.A & S.A), doors, windows, light fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
||||
| 2 | Change Room
Floor, walls,ceiling, diffuser frames (R.A & S.A), light fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
||||
| 3
|
Material Storage Area
Floor, walls,ceiling,doors,windows, Dust extraction pipe, diffusers (R.A & S.A), light fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
|
|
||
| 4
|
Washing room
Floor, walls, ceiling, steam, compressed air & water lines, drain, diffusers (R.A & S.A), light fixtures. |
Cleaning – Satisfactory /
Not satisfactory
|
||||
| 5
|
Inner corridors :
Floor, walls, windows,doors, Grills of HEPA filters, RA filters, RA filter housing, light fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
||||
| 6
|
Cleaned Equipment Storage room:
Floor, walls, windows,door, Grills of HEPA filters, RA filters, RA filter housing, light fixtures. |
Cleaning – Satisfactory /
Not satisfactory
|
||||
| 7
|
Sifting room :
Floor, walls, windows, door, Grills of HEPA filters, Compressed air line, DE pipe, RA filters, RA housing,drain pit, light fixtures. |
Cleaning – Satisfactory / Not satisfactory
|
||||
| 8
|
Granulation room :
Floor, walls, windows, door, Grills of HEPA filters, RA filters, RAF housing, DE pipes, steam, compressed air, water lines,drain pit,light fixtures. |
Cleaning – Satisfactory /
Not satisfactory
|
||||
| 9
|
Granule storage room :
Floor, walls, windows, door, Grills HEPA filters, RA filters, RA Filter housing, light fixtures. |
Cleaning – Satisfactory / Not satisfactory |
||||
| 10
|
Compression room :
Floor, walls, ceiling, windows, door, DES pipe, compressed air pipeline, Grills of HEPA filter, RA filter, RA filter housing, light fixtures. |
Cleaning – Satisfactory / Not satisfactory
|
||||
| 11
|
Compressed and/or coated tablets
storage room : Floor, walls, ceiling, windows, door, Grills of HEPA filters, RA filter, RA filter housing, light fixtures. |
Cleaning – Satisfactory / Not satisfactory
|
||||
| 12
|
Spare room :
Floor, walls, ceiling, windows, door, Grills of HEPA filters, RA filter, RA filter housing, light fixtures. |
Cleaning – Satisfactory / Not satisfactory
|
||||
| 13
|
Tablet Inspection room :
Floor, walls, ceiling, windows, Grills of HEPA filters, RA filter, RA filter housing, light fixtures. |
Cleaning – Satisfactory / Not satisfactory |
||||
| 14
|
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. |
Cleaning – Satisfactory / Not satisfactory
|
|
|||
| GENERAL INSPECTION | ||||||
| 15
|
Secondary gowning of previous
product removed. |
Yes / No
|
||||
| 16
|
No product containers of previous
product observed in process area. |
Yes / No | ||||
| 17
|
Any container of other product is
appropriately sealed & labeled. |
Yes / No |
||||
| 18
|
Empty product storage containers
are found cleaned. |
Yes / No |
||||
| 19
|
No packing material of previous
product found. |
Yes / No |
||||
| 20
|
No visible extraneous matter or
powder is observed in the facility. |
Yes / No | ||||
| 21
|
Equipment cleaned and
‘Equipment cleaned-Type C’ tag displayed. |
Yes / No
|
|
|||
| 22
|
Area cleaning checklist-Type C
filled and signed by Officer Production. |
Yes / No
|
||||
| 23 | Pre-filter cleaning entered in
‘Filter cleaning log’ |
Yes / No |
||||
| 24
|
Daily cleaning details and
cleaning and sanitation of drain points entered in respective logs. |
Yes / No |
||||
Annexure 6
Specimen format of “Area Clearance Checklist – Type C for Production CH’
| Previous Product : | Batch No.: | |||
| S.No. | Location of Inspection | Inspection inference of
QA Officer |
Signature of QA Officer | Remarks
|
| 1
|
Outer Corridor:
Floor , wall,ceiling, diffuser frames (R.A & S.A), doors, windows, light fixtures. |
Cleaning – Satisfactory /
Not satisfactory |
||
| 2
|
Change Room:
Floor,wall,ceiling, air supply and return air grills, electrical fixtures, lockers, shoe racks, doors and windows . |
Cleaning – Satisfactory /
Not satisfactory |
||
| 3
|
Material Hold Area :
Floor, wall, ceiling, air supply and return air grills, electrical fixtures, dust extraction pendent,doors and windows. |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 4
|
Wash Area :
Floor, wall, ceiling, air supply and return air grills, electrical fixtures,drainage pit, utility lines, doors and windows. |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 5
|
Equipment Hold Area :
Floor , wall,ceiling, HEPA filter grills. return air boxes and filters, equipment stands, doors and windows, electrical fixtures – cleaned. |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 6
|
Sifting Room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, equipments, utility lines,dust extraction pendent, doors and windows, electrical fixtures . |
Cleaning – Satisfactory / Not satisfactory |
||
| 7
|
Blending Room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, equipments, utility lines , dust extraction pendent,doors and windows, electrical fixtures . |
Cleaning – Satisfactory / Not satisfactory
|
||
| 8
|
Spare Parts Room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, machines, equipments, utility lines , dust extraction pendent,doors and windows, electrical fixtures . |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 9
|
Blend Hold Room
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, pallets, doors and windows, electrical fixtures . |
Cleaning – Satisfactory / Not satisfactory |
||
| 10
|
Empty Capsule Hold Room
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, pallets, doors and windows, electrical fixtures. |
Cleaning – Satisfactory / Not satisfactory |
||
| 11
|
Filled Capsule Quarantine Room:
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, pallets, doors and windows, electrical fixtures . |
Cleaning – Satisfactory / Not satisfactory |
||
| 12
|
Capsule Filling Room
Floor, wall, ceiling, HEPA filter grills, return air boxes and , filters,utility lines, dust extraction pendent,doors and windows, electrical fixtures . |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 13
|
Capsule Inspection Room
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, doors and windows, electrical fixtures . |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 14
|
Office Room:
Floor, wall, ceiling,HEPA filter grills return air boxes and filters, windows and doors, electrical fixtures. |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 15
|
Process Corridor :
Floor, wall, ceiling, HEPA filter grills, electrical fixtures |
Cleaning – Satisfactory /
Not satisfactory |
||
|
GENERAL INSPECTION |
||||
| 15
|
Secondary gowning of previous product removed. | Yes / No | ||
| 16
|
No product containers of previous
product observed in process area. |
Yes / No | ||
| 17
|
Any container of other product is
appropriately sealed & labeled. |
Yes / No |
||
| 18
|
Empty product storage containers
are found . |
Yes / No |
||
| 19
|
No packing material of previous
product found. |
Yes / No |
||
| 20
|
No visible extraneous matter or
powder is observed in the facility. |
Yes / No | ||
| 21
|
Equipment cleaned and
‘Equipment cleaned-Type C’ tag displayed. |
Yes / No
|
|
|
| 22
|
Area cleaning checklist-Type C
filled and signed by Officer Production. |
Yes / No
|
|
|
| 23
|
Pre-filter cleaning entered in
‘Filter cleaning log’ |
Yes / No |
||
| 24
|
Daily cleaning details and
cleaning and sanitation of drain points entered in respective logs. |
Yes / No
|
||
Annexure 7
Specimen format of “Area Clearance Checklist – Type C for Production CS’
| Previous Product : | Batch No.: | |||
| S.No. | Location of Inspection
|
Inference of QA Officer | Signature of QA Officer | Remarks
|
| 1
|
Outer Corridor:
Floor , wall,ceiling, diffuser frames (R.A & S.A), doors, windows,light fixtures. |
Cleaning – Satisfactory /Not satisfactory |
|
|
| 2
|
Change room :
Floor,wall,ceiling, air supply and return air grills, electrical fixtures, lockers, shoe racks, doors and windows. |
Cleaning – Satisfactory / Not satisfactory |
||
| 3
|
Material Hold area :
Floor, wall, ceiling, air supply and returnair grills, electrical fixtures, dust extraction pendent,doors and windows . |
Cleaning – Satisfactory / Not satisfactory |
||
| 4
|
Wash Area :
Floor, wall, ceiling, air supply and return air grills, electrical fixtures, drainage pit, utility lines, doors and windows . |
Cleaning – Satisfactory /Not satisfactory |
||
| 5
|
Medicament Process room:
Floor, wall,ceiling,utility lines, equipment, light fixtures, HEPA filter grills, return air boxes, return air filters, drain points, doors and windows, electrical fixtures |
Cleaning – Satisfactory / Not satisfactory |
||
| 6
|
Gelatin Process area :
Floor, wall, ceiling, utility lines, equipment platform, light fixtures, air supply grills, return air filters, drain points, doors and windows, electrical fixtures . |
Cleaning – Satisfactory / Not satisfactory |
|
|
| 7
|
Encapsulation area :
Floor , wall,ceiling, HEPA filter grills. return air boxes and filters, equipment stands, doors and windows, electrical fixtures . |
Cleaning – Satisfactory / Not satisfactory |
||
| 8
|
Drier room – 1 :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, doors , windows and equipment, electricla fixtures |
Cleaning – Satisfactory / Not satisfactory |
||
| 9
|
Drier room – 2 :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, doors , windows and equipment, electricla fixtures |
Cleaning – Satisfactory / Not satisfactory | ||
| 10
|
Capsule Wash room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, equipments, utility lines , dust extraction pendents, doors and windows, electrical fixtures – |
Cleaning – Satisfactory /
Not satisfactory
|
||
| 11
|
Capsule inspection room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, equipments, utility lines , dust extraction pendents, doors and windows, electrical fixtures – |
Cleaning – Satisfactory / Not satisfactory
|
||
| 12
|
Office room :
Floor, wall, ceiling,HEPA filter grills return air boxes and filters, cupboards, working table, chairs, windows and doors, electrical fixtures. |
Cleaning – Satisfactory / Not satisfactory |
||
| 13
|
Capsule Quarantine :
Floors, wall, ceiling, HEPA filter grills, return air boxes and filters, pallets, doors and windows, electrical fixtures. |
Cleaning – Satisfactory / Not satisfactory | ||
| 14
|
Equipment room :
Floor, wall, ceiling, HEPA filter grills, return air boxes and filters, pallets, doors and windows,electrical fixtures . |
Cleaning -Satisfactory / Not satisfactory
|
||
| 15
|
Capsule printing and Polishing room :
Floor, wall, ceiling, light fixtures, HEPA filter grills, return air boxes and filters, equipment, utility lines, doors and windows, electrical fixtures. |
Not satisfactory
|
||
|
GENERAL INSPECTION |
||||
| 16
|
Secondary gowning of previous product removed. | Yes / No | ||
| 17
|
No product containers of previous
product observed in process area. |
Yes / No | ||
| 18
|
Any container of other product is
appropriately sealed & labeled. |
Yes / No |
||
| 19
|
Empty product storage containers
are found cleaned. |
Yes / No |
||
| 20
|
No packing material of previous
product found. |
Yes / No |
||
| 21
|
No visible extraneous matter or
powder is observed in the facility. |
Yes / No
|
||
| 22
|
Equipment cleaned and
‘Equipment cleaned-Type C’ tag displayed. |
Yes / No
|
||
| 23
|
Area cleaning checklist-Type C
filled and signed by Officer Production. |
Yes / No
|
||
| 24
|
Pre-filter cleaning entered in
‘Filter cleaning log’ |
Yes / No |
||
| 25
|
Daily cleaning details and
cleaning and sanitation of drain points entered in respective logs. |
Yes / No
|
|
|
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