Installation Qualification of QC- Facility Qualification consists of the installing QC laboratory in the existing and new facility. The Installation Qualification (IQ) phase provides documented verification that all structural elements, environmental control systems, utilities, and analytical equipment for the Quality Control (QC) laboratory have been correctly installed and configured in accordance with the approved Design Qualification (DQ), User Requirements Specifications (URS), and prevailing Good Manufacturing Practice (GMP) standards.
TABLE OF CONTENT
| Description | Page No. |
| Title Page | |
| Table of Contents | |
| Pre – Approval of Documents | |
| Objective | |
| Scope | |
| Responsibilities | |
| Facility Installation Operation Brief Description | |
| Critical Attributes to be met while Installing facility | |
| Critical Attributes to be met while operating facility | |
| General observation Checklist for Installation Qualification | |
| Installation Specifications (Area Wise) | |
| Summary and Conclusion for IQ | |
| Post Approval of Installation Qualification | |
| General observation Checklist for Installation Qualification | |
| Abbreviations | |
| Reference | |
| Post Approval of Document | |
| Revision History |
Pre-Approval of Documents:
PREPARED BY:-
| Name | Designation/Department | Signature | Date |
REVIEWED BY:-
| Name | Designation/Department | Signature | Date |
APPROVED BY:-
| Name | Designation/Department | Signature | Date |
Objective considered Installation Qualification of QC- Facility Qualification :
This document is generating under the authority of the XYZ company for the purpose of specifying the Installation Operation Qualification for new Quality Control Lab. To establish documented evidence that the Quality Control (QC) area infrastructure, utilities, and environmental conditions are installed correctly Installation Qualification in compliance with predefined specifications.
Scope:
The scope of this document is to define the requirements for new Quality Control lab.in XYZ Company.
Responsibilities
| Department | Responsibility |
| Quality assurance | Preparation of Installation Operation Qualification protocol cum report Execution of Installation Operation Qualification Review of IOQ Pre & Post Approval of IOQ Responsible for the compliance of IOQ |
| Engineering | Review of IOQ Support in execution of Installation Operation Qualification To assist concerned department for the preparation of IOQ |
| Quality Control | Review of IOQ To assist concerned department for the preparation & execution of IOQ |
Installation Qualification of QC- Facility Qualification Brief Description :
The Quality Control (QC) facility is designed, installed & operated to support analytical testing of raw materials, in-process samples, and finished products in compliance with applicable regulatory requirements.
The installation & Operation includes:
Facility Layout & Segregation:
The QC area is properly segregated into designated sections such as chemical testing laboratory, instrument room, sample receipt & storage area, and documentation area. Layout ensures unidirectional flow of personnel and materials to prevent cross-contamination.
Civil & Structural Components:
Walls, floors, and ceilings are constructed with smooth, cleanable, and non-reactive materials. Adequate drainage and pest control measures are implemented.
Utilities Installation:
Essential utilities including electrical supply, purified water system (if required), and HVAC systems are installed and operated as per design specifications.
Laboratory Equipment & Instruments:
Analytical instruments (e.g., HPLC, UV spectrophotometer, balances) are installed as per manufacturer specifications, properly labeled, and calibrated.
Safety Systems:
Installation of fire extinguishers, eye wash stations, fume hoods, and emergency exits is verified.
Documentation:
Availability of equipment manuals, calibration certificates, SOPs, and layout drawings is ensured.
Critical Attributes to be met while Installation Qualification of QC- Facility Qualification
Facility Design & Layout
- Adequate segregation of different functional areas (chemical, instrumental)
- Logical workflow to avoid cross-contamination and mix-ups
- Sufficient space for equipment operation and maintenance
Construction & Finishes
- Smooth, non-shedding, and easily cleanable surfaces (walls, floors, ceilings)
- Chemical-resistant work surfaces
- Proper drainage and pest control provisions
Utilities
- Reliable electrical supply with proper earthing
- Adequate number of power points for instruments
- Availability of required utilities:
- HVAC system
- Purified water system (if required)
HVAC & Environmental Control
- Proper installation of HVAC system
- Defined temperature and humidity control
- Adequate ventilation
Safety Systems
- Installation of fire extinguishers
- Availability of eye wash stations with safety showers
- Proper installation of fume hoods and exhaust systems
Documentation
- Approved layout drawings
- SOPs for operation and maintenance
- Equipment manuals and qualification documents
General Observation Checklist for Installation Qualification of QC- Facility Qualification
| Objective | Observation |
| Area Cleanliness | |
| Completion of Design Qualification |
Installation Specifications (Area Wise)
Section usually lists the Installation Operation requirements and specifications for each functional area of the facility, system, or equipment. This helps verify that the Installation Operation meets regulatory, Design Qualification (DQ) and GMP requirements.
Change Room, Instrumentation room, Chemical Lab, Sample Storage area, Balance room, Chemical storage required Installation Qualification of QC- Facility Qualification
| CHECK POINTS | REQUIREMENT |
| Description | |
| Check the dimension of the room (length, width, and height in meters / metric system). | Should be adequate as per drawing |
| Access control | Access control should be installed |
| Identification | |
| Area Finish | |
| Area Epoxy work | Should be Neat and clean |
| Panel Surface finish | Suitable paint depending on wall type (if any) |
| Panel to panel joints/gaps with Silicon work finish | PP strips coving available |
| Panel to panel coving with PP strips | Coving should be available |
| PP strips coving with silicon work finish | There should be no gaps remaining |
| Wall to floor coving with sand coving | Coving surface should be smooth |
| Sand coving surface finish should be smooth | Coving surface should be smooth |
| Floors of Area | |
| Ensure floor to wall corners have smooth coved surfaces. | Coving surface should be smooth |
| Ensure slope has easy flow of water towards drain where ever it is required. | Slope should be towards the drain point |
| Ensure that floor surface in the area is easy to clean. | Floor surface should be easy to clean |
| Ceiling of Area & Air lock: | |
| Verify the appropriate ceiling of the area. | No gaps should be found |
| Ceiling to panel/wall coving with PP strips | Coving should be smooth and cleaned |
| Doors of Area & Air lock: | |
| Numbers of door as per area. | – |
| Check that proper direction stickers are provided in all door i.e, (Push and Pull). | – |
| Door view glass availability finished with silicon work | There should be no gap b/w view glass and door |
| Number of Door Closer | – |
| Number of Door SS handle | – |
| Door electric magnet (if interlocking in place) is installed | – |
| Direction of door | Opens towards positive or pressure |
| Door Base air seal (Drop Seal) | |
| Door Interlocking Switches | |
| Panel/View Panel/window of Area | |
| Ensure that it is properly sealed to prevent dirt accumulation. | Flush with wall panels to avoid dust accumulation |
| Check the material of construction, as per design. | Pre-coated panels with PUF (Polyurethane Foam) insulation Double-glazed toughened glass |
| Check single/double glass, colour of glass, type of glass as per requirement. | Double-glazed toughened glass Flush fitted with panel system |
| No. of view panel | – |
| View panel glass should be present with silicon work finish | There should be no gap b/w window glass and panel/wall |
| Electrical Works: | |
| Wiring of Area: | |
| Electric switches at respective location | – |
| Verify all the electrical cables present in the room are concealed. | Electrical switches should be concealed |
| Lighting of Area | |
| Number of LED/Monochromatic lights of area as per drawing | – |
| Location of the connections and its voltage and phase. | Connections should be concealed |
| Size of LED/Monochromatic lights as per drawing | – |
| Openable from area side by screw or from service floor | – |
| No. of electrical switches/sockets | Electrical of switches should be concealed |
| Air Handling System of Area | |
| Check the number of Supply grills in area | – |
| Check the number of Return grills in area | – |
| Supply grills are fixed (Screw/magnet) | – |
| Return grills are fixed (Screw/magnet) | – |
| Services/Utilities: | |
| Machine Utility Supply Line Availability | Required and supply line should be concealed |
| Compressed Air line availability | – |
| Power plugs and sockets | Should be concealed |
| Process water supply line | – |
| Purified water supply loop (if applicable) | Purified water line should be available and marked |
| Drains: | |
| Check number of drain points. | Should be GMP drains |
| Check the slope for water draining. | Slope should be towards the drain |
| Check the wash basin/sink | – |
| General Requirement : | |
| Man movement and Material Flow: | |
| Availability of entry and exit for man and material flow. | – |
| Pass Box | |
| Check number of pass box and its type static or dynamic as per requirement.(If applicable) | – |
Summary and conclusion for Installation Qualification
__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Post Approval of Installation Qualification
CHECKED BY:-
| Name | Designation/Department | Signature | Date |
REVIEWED BY:-
| Name | Designation/Department | Signature | Date |
APPROVED BY:-
| Name | Designation/Department | Signature | Date |
FAQ’s for for Installation Qualification of QC- Facility Qualification
Q: What is a QC Lab IQ?
Answer: It is the documented proof that all lab structures, utilities, HVAC systems, and instruments are installed correctly and meet GMP standards.
Q: How does IQ differ for a new vs existing facility?
Answer: A new facility focuses on fresh utility, HVAC and cleanroom while an existing facility focuses on safe integration.
Q: What are the main things checked during IQ?
Answer: Floor epoxy, coving, Panels, doors, HVAC systems, HEPA filters, grills, pressure gauges, utilities like purified water, and proper instrument placement.
Q: What happens if anything fails during IQ ?
Answer: If anything shall be failed then deviation shall be raised and the issue shall be corrected and re-verified before proceed to further stage.