FACILITY VALIDATION PROTOCOL

FACILITY VALIDATION PROTOCOL

FACILITY VALIDATION PROTOCOL

TABLE OF CONTENTS

SR. NO.	CONTENTS	PAGE NO.
1.0	APPROVAL
2.0	OBJECTIVE
3.0	SCOPE
4.0	RESPONSIBILITY
5.0	PROCEDURE
6.0	ACCEPTANCE CRITERIA
7.0	REQUALIFICATION CRITERIA
8.0	ABBREVIATIONS
9.0	REFERENCE

1.0 APPROVAL 

The FACILITY VALIDATION PROTOCOL for Production Granulation area has been initiated, Checked, Approved and Authorized by the following functional heads.

INITIATED BY

DESIGNATION	NAME	SIGNATURE	DATE
Validation Executive
Production Officer / Executive
Engineering Executive

CHECKED BY

DESIGNATION	NAME	SIGNATURE	DATE
Engineering Head
Production Head

APPROVED BY

DESIGNATION	NAME	SIGNATURE	DATE
Quality Assurance Head

AUTHORIZED BY

DESIGNATION	NAME	SIGNATURE	DATE
General Manager

2.0 OBJECTIVE: –

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

3.0 SCOPE: –

3.1 To perform the Facility validation for Production Granulation  area.

4.0 RESPONSIBILITY: –

Validation Executive

Engineering Executive

Production Executive

[Name shall be mentioned in the report with sign]

5.0 PROCEDURE: –

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

5.2 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.

5.3 Record abbreviations used in the report.

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

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

6.0 ACCEPTANCE CRITERIA: 

Facility checklist shall include 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:-  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	ERIFICATION	REMARKS
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 frame and 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:  Carryout the following checks with respect to electrical works.
WIRING:
CONCEALING OF WIRING	All the electrical cables shall be concealed
ELECRICAL 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	VERIFICATION	REMARKS
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:  Carryout 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 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	VERIFICATION	REMARKS
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 PIPE LINE / 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 Galvazed Iron pipeline.
MOC OF CONTROL VALVE	Nickel coated SS sheeting
LEAKAGE	There shall not be any leakage found in the chilled water pipe line.
DUST EXTRACTION:
NO. OF POINTS	Based on the area requirement
MODE OF EXTRACTION	Negative suction using motor

 

PARAMETER	SPECIFICATION	VERIFICATION	REMARKS
E] EQUIPMENT: Carryout 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: Carryout 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 Carryout 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 Carryout 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	VERIFICATION	REMARKS
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 frame and 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:  Carryout the following checks with respect to electrical works.
WIRING:
CONCEALING OF WIRING	All the electrical cables shall be concealed
ELECRICAL 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	VERIFICATION	REMARKS
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:  Carryout 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	VERIFICATION	REMARKS
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 PIPE LINE /  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 Galvazed Iron pipeline.
MOC OF CONTROL       VALVE	Nickel coated SS sheeting
LEAKAGE	There shall not be any leakage found in the chilled water pipe line.
DUST EXTRACTION:
NO. OF POINTS	Based on the area requirement
MODE OF EXTRACTION	Negative suction using motor

 

PARAMETER	SPECIFICATION	VERIFICATION	REMARKS
E] EQUIPMENT: Carryout 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: Carryout 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 Carryout 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 Carryout 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	Observation
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	Observation
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	Observation
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	Observation
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	Observations
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 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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