QA AUDIT POINTS

1 De-Cartoning Room
2 R&D
3 Printing Area
4 Syrup Manufacturing Area
5 Quarantine Area
6 Title Page of Log Books

7 Micro Department

PRODUCTION AUDIT POINTS

SYRUP MANUFACTURING AREA

1 SOP

2 Cleaning Required

3 Engineering work

4 Transfer Tank

5 Utensils

Miss. Shaista kindly take look on these points and to make sure all above points sho
clear by Monday

EYE DROP AREA

1 Status of Gate

2 Clear room
3 Buffing required

Cleaning required in eye drop area, windows, doors, floors and every machine/equi
should be clean
Miss Shaista, its your responsibility to make sure all above points should be clea
Monday.
Cleaning required in eye drop area, windows, doors, floors and every machine/equi
should be clean
Miss Shaista, its your responsibility to make sure all above points should be clea
Monday.

PACKING HALL (G.P)

1 Cleaning Required

2 Labelling required

3 SOP & Log Book

4 Buffering

Mazhar Sir and Miss Shaista, it is your responsibility to make sure all above points
be clear by Monday

IN-PROCESS QUARANTINE AREA

1 SOP

2 Cleaning Required

Mazhar Sir , it is your responsibility to make sure all above points should be clea
Monday

DRY POWDER SUSPENSION

1 Cleaning Required

2 Log books

3 Magnehelic

DE-CARTONING BOTLLE ROOM

1 Cleaning Required
2 SOP

GRANULATION ROOM

1 Sieves

2 Cleaning required

MIXING ROOM

1 Cleaning Required

2 Cone Blender

DRYING ROOM
1 LogBook

2 Cleaning Required

ENCAPSULATION ROOM
1 SOP

2 Cleaning Required

COATING ROOM
1 Thia Coater

2 Cleaning Required

TABLET COMPRESSION ROOM 1 & 2

1 Log Books

2 Magnehelic
 R&D ROOM
1 SOPs
2 Performance Qualification

3
Cleaning Required
Mazhar Sir , it is your responsibility to make sure all above points should be clea
Monday
Kindly make your departments presentable.

AMPOULE AREA
1 Liquid Injectable Area
2 Ampoule Washing Area
3 Infusion Vial machine
4 Packing Hall
 QA AUDIT POINTS
SOP of compress Air is required.
SOPS are in plan.
SOP & Logbook are required
SOP of Riser Cleaning
SOP is required.
Kindly change Title page of those logbooks on which
validity Year is written from 2017-2018.

1) SOP of water charge

2)SOP of water Tank cleaning
(Above 2 points can be merged in RO PLANT SOP)
3)Log book of water tank cleaning

PRODUCTION AUDIT POINTS

SYRUP MANUFACTURING AREA

SOP of Riser cleaning is required

1)All machines should be clean

2)Remove Winthrox tape from every machine
3)Change filling pipes of filling machine
4)Paint required

1) Lights required
2) Electric pipe cover should be changed
Status of mixing Vessel should be changed to Transfer
tank
Kindly dry, packed your utensils in polybag and than
label it.

e look on these points and to make sure all above points should be
clear by Monday

EYE DROP AREA

Status of door has to be change from washing room to

Autoclave room.

Remove cartons from autoclave room

autoclave needs buffing

e drop area, windows, doors, floors and every machine/equipment

should be clean
r responsibility to make sure all above points should be clear by
Monday.
 PACKING HALL (G.P)

1) Remove extra packing material

There should be one packing material for printing at
a time
2)Trays, stools, pipes, cameras, doors, windows should be
clean.
3) Remove extra master cartons.
4) Change all plastic wrinkled pipe.

Conveyor belt
printing machine
Printing Machine

Every machine needs buffering

haista, it is your responsibility to make sure all above points should

be clear by Monday

IN-PROCESS QUARANTINE AREA

Quarantine SOP is required

All cartons present in quaratine area should be placed
on pellets.

r responsibility to make sure all above points should be clear by

Monday

DRY POWDER SUSPENSION

Area should be clear from bottles.

DRT not allowed
Floor, Door , Windows , machines should be clean

should be maintained

Check whether its working or not.

DE-CARTONING BOTLLE ROOM

Clear Area
 SOP of Compress Air is required.

GRANULATION ROOM

Identification number on sieves should be mentioned

1) Boiling tubs should be clean.

2) Granulators, ribbon mixer should be clean.
3) Remove winthrox tape from machines.
3) Buffering required.
4)Proper drainage system.
5) Floor, doors, windows should be clean
MIXING ROOM

1) Machines should be clean

2) Buffering required
3) Doors, windows, SOPs holder should be clean
Screws of cone blender should be cleaned

DRYING ROOM

HVAC ( Printing)

1) Machines should be clean

2) Buffering required
3) Doors, windows, SOPs holder should be clean
4) Paint on FBD is Required
ENCAPSULATION ROOM
Capsule polishing

1) Machines should be clean

2) Buffering required
3) Doors, windows, SOPs holder should be clean
4) Paint on FBD is Required
COATING ROOM
Label UNINSTALLED shouldbe paste on it.

1) Machines should be clean

2) Buffering required
3) Doors, windows, SOPs holder should be clean
4) Paint on FBD is Required
TABLET COMPRESSION ROOM 1 & 2

Kindly check thsese 2 log books, whether it is available

in dept or not:
Area Monitoring
HVAC
Magnehelic is required
 R&D ROOM

SOPs are in plan

Are in plan.
Clear Room
Doors, windows, machines should be clean.
r responsibility to make sure all above points should be clear by
Monday
Kindly make your departments presentable.

AMPOULE AREA
Lights are required.
Ampoule washing machine's Needles are damaged
Should be labelled with "To be Installed"
Light fixing is required
 CEPHALOSPORIN AUDIT POINTS

VIAL TRANSFER / RAW MATERIAL TRANSFER/ WATER

1 Cleaning required Clear area
2 SOP Compress air SOP is required
VIAL WASHING AREA AND AUTOCLAVE AREA
1 Pass through window Glass of passthrough window is broken

Hood has removed

2 Vial washing machine
pipe leakage

Pellets are not clean

removed extra cartons, drums
3 Cleaning Required buffering of machine required
Doors, glass, floors should be clean.

All drums, equipments, machines should be labelled

4 Labelling required
properly what ever the status is..
PACKING & PRINTING HALL
1 SOP & LOGBOOK Printer SOP & Logbook required
removed extra cartons, drums
2 Cleaning required buffering of machine required
Doors, glass, floors should be clean
DRY POWDER VIAL AREA
Filling, sealing and cleaning SOPs are missing from
1 SOPs are missing
the department

Epoxy required
2 Cleaning required Paint required
Glass, doors , windows should be clean
3 Executive entrance Required cabinets
CAPSULATION AREA
1 SOP SOP of pass through is required

removed extra cartons, drums

2 Cleaning required buffering of machine required
Doors, glass, floors should be clean

LABELLING ROOM & OPTICAL ROOM

1 Status of door required
2 Optical table is required
IN-PROCESS QUARANTINE AREA
1 SOP is required
 Mazhar Sir AND Rehan Sir, it is your responsibility to make sure all above points
should be clear by Monday
Its your responsibility also to ask QA for SOPS, Ask Engineering dept for fixing etc etc