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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