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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.

For More Pharma Updates Visit –https://pharmaguidances.com

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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