Home / QA & QC / Process Area clearance during batch/product changeover

Process Area clearance during batch/product changeover

  • 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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