FACILITY VALIDATION PROTOCOL

FACILITY VALIDATION PROTOCOL

To ensure that the Facility installed, for the Production Granulation area conforms with the predetermined acceptance criteria.

SCOPE OF FACILITY VALIDATION PROTOCOL: –

To perform the Facility validation for Production Granulation  area.

RESPONSIBILITY: –

Validation Executive

Engineering Executive

Production Executive

PROCEDURE: –

Check the facility as per acceptance criteria in granulation  area and shall record  the observations in the report as per Installation checklist.

Document any discrepancies or variations noted during the Facility validation for

Production Granulation area. Record the corrective actions taken to rectify the discrepancy in the report.

Record abbreviations used in the report.

Attach all related documents to the report as an annexure and record in the report.

Finally report shall be summarized, concluded, and approved by functional heads. 

ACCEPTANCE CRITERIA: 

The facility checklist shall include the following points. 

Location:                                                 Room no.:

Purpose of area for use:                        Dimension of area:

Dimension Designed specification Observation
Height (Meter)
Length (Meter)
Width (Meter)
Area (M2 / Ft2)
Volume (M3 / Ft3)

 

PARAMETER SPECIFICATION VERIFICATION REMARKS
A] CIVIL WORKS:- Carry out the following checks with respect to civil works.
WALLS:
WALL MATERIAL Brick wall with cement mortar
CRACKS/ CREVICES There shall not be any cracks / crevices on the wall
SURFACES The wall surfaces shall be having smooth surfaces
TYPE OF PAINT   APPLIED Synthetic enamel /

Oil bound distemper

COLOUR SHADE Honey Dew
FLOORING:
FLOOR MATERIAL Kota stone / Shabad stone / Ceramic Tile (Based on the area)
COVING Floor to wall corners shall be having smooth coved surfaces
CREVICES There shall not be any crevices on the floor.
SLOPE TOWARDS DRAIN The slope shall be proper to make easy flow of water towards drain.
EASE OF CLEANING The floor surfaces in the area shall be easy to clean.
STONE JOINT MATERIAL Epoxy / Cement

(Based on the area)

CEILING:
CEILING MATERIAL Gypsum board / Cement concrete (based on the area)

 

PARAMETER SPECIFICATION
CRACKS/ GAPS AT LIGHT FIXTURES There shall not be any cracks/gaps on the ceiling, at light fixtures.
TYPE OF PAINT

APPLIED

Synthetic enamel / Oil bound distemper
COVING Ceiling to wall corners shall be having smooth coved surfaces
COLOUR SHADE Dull white
DOORS:
MATERIAL OF CONSTRUCTION Aluminum frame with partly laminated bison and partly glazing
MARKING OF PUSH / PULL PULL / PUSH shall be marked in all doors.
FRAME ATTACHMENT

TO WALLS

There shall not be any projections or crevices between the frame and the wall surface
WINDOWS:
MATERIAL OF

CONSTRUCTION

Aluminum frame with fully fixed tough / plane / frosted glass
NUMBER OF WINDOWS Based on the area requirement
FRAME ATTACHMENT TO WALLS There shall not be any projections or crevices between frame and wall surface
B] ELECTRICAL WORKS: Carry out the following checks with respect to electrical works.
WIRING:
CONCEALING OF WIRING All the electrical cables shall be concealed
ELECTRICAL SOCKETS Joints between electrical sockets and wall surface shall be coved.
NO. OF SOCKETS/ CAPACITY Sockets of 5-15 amp or 20-30 amp capacity based on the area requirement.

 

PARAMETER SPECIFICATION
LIGHTING:
NO. OF LIGHT FIXTURES Based on the area requirement
LUX LEVEL 150 to 300 – Storage areas

250 to 400 – Process areas

C] AIR HANDLING SYSTEM: Carry out the following checks with respect to AHU.
NO. OF INLET AIR GRILLS

GRILL DIMENSIONS

Based on the area requirement
As per Annexure – I
NO. OF RETURN AIR GRILLS GRILL DIMENSIONS Based on the area requirement
As per Annexure – I
TEMPERATURE 22 ± 2º C
HUMIDITY i) 50 ± 10 %

ii) 35 ± 5%

NUMBER OF AIR   CHANGES/HOUR i) NLT 30

ii) NLT 15

PRESSURE DIFFERENTIAL All the process areas shall have negative pressure with respect to the internal corridor.
D] SERVICES/UTILITIES: Carryout the following checks with respect to services and utilities
COMPRESSED AIR:
NO. OF POINTS Based on the area requirement
SIZE OF PIPELINE / MOC ½ inch, SS 316
MOC OF CONTROL VALVE Teflon coated SS sheeting
LEAKAGE There shall not be any leakage found.

 

PARAMETER SPECIFICATION
POTABLE WATER:
NO. OF POINTS Based on the requirement
SIZE OF PIPELINE / MOC ½ inch, SS 316
MOC OF CONTROL VALVE SS 316, diaphragm valve
LEAKAGE There shall not be any leakage found.
PURIFIED WATER:
NO. OF POINTS Based on the requirement
SIZE OF PIPELINE / MOC ½ inch, SS 316
MOC OF CONTROL VALVE SS 316, diaphragm valve
LEAKAGE There shall not be any leakage found.
CHILLED WATER:
NO. OF POINTS Based on the requirement
SIZE OF PIPE LINE /MOC ½ inch Galvanized Iron pipeline.
MOC OF CONTROL VALVE Nickel-coated SS sheeting
LEAKAGE There shall not be any leakage found in the chilled water pipeline.
DUST EXTRACTION:
NO. OF POINTS Based on the area requirement
MODE OF EXTRACTION Negative suction using motor

 

PARAMETER SPECIFICATION
E] EQUIPMENT: Carry out the following checks with respect to equipments.
CLEANING The equipment shall be cleaned as per the relevant cleaning SOP.
MAN / MATERIAL      MOVEMENT There shall be adequate space for man and material movement.
INSTALLED EQUIPMENTS The equipment relevant to the operation shall be installed.
F] SAFETY: Carry out the following checks related to Safety.
ACCESSIBILITY EMERGENCY DOOR Emergency door shall be easily accessible in the area. Emergency door shall be marked with separate label.
ACCESSIBILITY TO FIRE EXTINGUISHER Fire extinguisher shall be easily accessible in the area with SOP.
ACCESSIBILITY TO FIRST AID BOX Information regarding first aid box shall be available in the area.
G] SANITATION
AREA CLEANING The area shall be thoroughly cleaned as per the relevant SOP.
FUMIGATION

Carry out the fumigation for all critical areas.

Specifications for fumigation:

84 gm. of Potassium permanganate in 0.252 kg of formalin per 1000 cu.ft of area.

AREA SETTLE PLATE

Carry out the area settle plate as per SOP.

Total microbial count:

NMT – 100 CFU/ plate

Total fungal count:

NMT – 10 CFU /plate

 

PARAMETER SPECIFICATION
A] CIVIL WORKS:- Carryout the following checks with respect to civil works.
WALLS:
WALL MATERIAL Brick wall with cement mortar
CRACKS/ CREVICES There shall not be any cracks / crevices on the wall
SURFACES The wall surfaces shall be having smooth surfaces
TYPE OF PAINT   APPLIED Synthetic enamel /

Oil bound distemper

COLOUR SHADE Honey Dew
FLOORING:
FLOOR MATERIAL Kota stone / Shabad stone / Ceramic Tile (Based on the area)
COVING Floor to wall corners shall be having smooth coved surfaces
CREVICES There shall not be any crevices on the floor.
SLOPE TOWARDS DRAIN The slope shall be proper to make easy flow of water towards drain.
EASE OF CLEANING The floor surfaces in the area shall be easy to clean.
STONE JOINT    MATERIAL Epoxy / Cement

(Based on the area)

CEILING:
CEILING MATERIAL Gypsum board / Cement concrete (based on the area)

 

PARAMETER SPECIFICATION
CRACKS/ GAPS AT

LIGHT FIXTURES

There shall not be any cracks / gaps on the ceiling, at light fixtures.
TYPE OF PAINT   APPLIED Synthetic enamel / Oil bound distemper
COVING Ceiling-to-wall corners shall have smooth coved surfaces
COLOUR SHADE Dull white
DOORS:
MATERIAL OF CONSTRUCTION Aluminum frame with partly laminated bison and partly glazing
MARKING OF   PUSH

PULL

PULL / PUSH shall be marked in all doors.
FRAME ATTACHMENT    TO WALLS There shall not be any projections or crevices between the frame and the wall surface
WINDOWS:
MATERIAL OF

CONSTRUCTION

Aluminum frame with fully fixed tough / plane / frosted glass
NUMBER OF WINDOWS Based on the area requirement
FRAME ATTACHMENT       TO WALLS There shall not be any projections or crevices between the frame and the wall surface
B] ELECTRICAL WORKS: Carry out the following checks with respect to electrical works.
WIRING:
CONCEALING OF WIRING All the electrical cables shall be concealed
 ELECTRICAL SOCKETS Joints between electrical sockets and wall surface shall be coved.
NO. OF SOCKETS CAPACITY Sockets of 5-15 amp or 20-30 amp capacity based on the area requirement.

 

PARAMETER SPECIFICATION
LIGHTING:
NO. OF LIGHT FIXTURES Based on the area requirement
 LUX LEVEL 150 to 300 – Storage areas

250 to 400 – Process areas

C] AIR HANDLING SYSTEM: Carry out the following checks with respect to AHU.
NO. OF INLET AIR GRILLS

GRILL DIMENSIONS

Based on the area requirement
As per Annexure – I
  NO. OF RETURN AIR   GRILLS

 

GRILL DIMENSIONS

Based on the area requirement
As per Annexure – I
TEMPERATURE 22 ± 2º C
HUMIDITY i) 50 ± 10 %
NUMBER OF AIR  

CHANGES/HOUR

i) NLT 30

 

PRESSURE DIFFERENTIAL All the process areas shall have negative pressure with respect to the internal corridor.
D] SERVICES/UTILITIES: Carryout the following checks with respect to services and utilities
COMPRESSED AIR:
NO. OF POINTS Based on the area requirement
SIZE OF PIPE LINE /MOC ½ inch, SS 316
MOC OF CONTROL VALVE Teflon-coated SS sheeting
LEAKAGE There shall not be any leakage found.

 

PARAMETER SPECIFICATION
POTABLE WATER:
NO. OF POINTS Based on the requirement
SIZE OF PIPE LINE /MOC ½ inch, SS 316
MOC OF CONTROL VALVE SS 316, diaphragm valve
LEAKAGE There shall not be any leakage found.
PURIFIED WATER:
NO. OF POINTS Based on the requirement
SIZE OF PIPELINE /  MOC ½ inch, SS 316
MOC OF CONTROL    VALVE SS 316, diaphragm valve
LEAKAGE There shall not be any leakage found.
CHILLED WATER:
NO. OF POINTS Based on the requirement
SIZE OF PIPELINE /MOC ½ inch Galvazed Iron pipeline.
MOC OF CONTROL VALVE Nickel-coated SS sheeting
LEAKAGE There shall not be any leakage found in the chilled water pipeline.
DUST EXTRACTION:
NO. OF POINTS Based on the area requirement
MODE OF EXTRACTION Negative suction using motor

 

PARAMETER SPECIFICATION
E] EQUIPMENT: Carry out the following checks with respect to equipments.
CLEANING The equipment shall be cleaned as per the relevant cleaning SOP.
MAN / MATERIAL MOVEMENT There shall be adequate space for man and material movement.
INSTALLED EQUIPMENT The equipment relevant to the operation shall be installed.
F] SAFETY: Carry out the following checks related to Safety.
ACCESSIBILITY TO

EMERGENCY DOOR

Emergency door shall be easily accessible in the area. Emergency door shall be marked with separate label.
ACCESSIBILITY TO

FIRE EXTINGUISHER

Fire extinguisher shall be easily accessible in the area with SOP.
ACCESSIBILITY TO

FIRST AID BOX

Information regarding first aid box shall be available in the area.
G] SANITATION
AREA CLEANING The area shall be thoroughly cleaned as per the relevant SOP.
FUMIGATION

Carry out the fumigation for all critical areas.

Specifications for fumigation:

84 gm. of Potassium permanganate in 0.252 kg of formalin per 1000 cu.ft of area.

AREA SETTLE PLATE

Carry out the area settle plate as per SOP.

Total microbial count:

NMT – 100 CFU/ plate

Total fungal count:

NMT – 10 CFU /plate

Area Details:

Sr. No. Description Designed specification
1. Walls
A Type:
B Finish
C Painting
D Shade
2. Ceiling
A Type
B Finish
C Painting
D Shade
3. Flooring
A Type
B Jointing
C Finish
4. Skirting / Dado
A Type
B Jointing
C Finish
5. Coving
A Wall to floor
B Wall to wall
C Wall to false ceiling
D Wall to return air riser
E Wall to door frame

 

Sr. No. Description Designed specification
6. Door
A Type
B Dimension (W X H meter)
C No of doors
D Location
E Painting
F No and type of door closer
G No and type of handle
H No and type fender
I Size of glass view panel
J Door interlocking
7. Windows
A Type
B No of windows
C Dimensions (W x H meter)
D Jointing
A1 Type
B No of windows
C Dimensions (W x H meter)
D Jointing

 

Sr. No. Description Designed specification
8. Cutouts in ceiling
A Electrical light fittings:
Nos.
Finish
B Pendants:
Nos.
Finish
C Dust extraction pendants:
Nos.
Finish
D HVAC diffusers
Nos.
Finish
E Return air riser
Nos.
Finish
9. Drainage
A Type of trap
B No and location
C Material of construction

 

Sr. No. Description Designed specification
10. Electrical work
A Wiring type
B No of light fittings and type
C Arrangement for emergency light
D No of telephone points
E No of computer points
F Power sockets:
No of single phase sockets & type
No of three phase sockets & type
G No of lighting switch box & type
H Illumination level in Lux
11. HVAC system
A No of diffusers
B Specification of diffusers:
Return
Supply
C Maximum no of persons
D No of air changes (NLT)
E Temperature [° c]
F Relative humidity % NMT
G Conditioning

 

Sr. No. Description Designed specification
H Differential Pressure
I Room ISO class
12. Building management system
A Indication box
Size
Location
Indication for pressure
Indication for temperature
Indication for humidity
B Door status
13. Utility services
A Purified water
B Process water
C Compressed air
14. Other facilities
A Fly killer
B Air curtain
C PVC strip door
D SS corner angle
E SS fenders
F Fan
G Safety
H Pass box

7.0 REQUALIFICATION CRITERIA: –

7.1 Facility validation for the Production Granulation area shall be re-qualified if.

8.0 ABBREVIATIONS: –

SR. No. Acronym Definition
1. M2 / Ft2 Square meter / Square Feet
2. M3 / Ft3 Cubic meter / Cubic Feet
3. W x H Width X Height
4. HVAC Heating, Ventilation, Air Conditioning
5. NLT Not Less Than
6. ° C Degree
7. NMT Not More Than
8. % Percentage
9. PVC Polyvinyl Chloride
10. SS Stainless Steel
11. ISO International Standard Organization
12. no. Number

9.0 REFERENCE: –

9.1 Guidelines of the Good Manufacturing Practices, Part 2, Validation.

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