Operation Qualification of Stability Area is performed to verify that the installed facility operates as per predefined specifications. It confirms the proper functioning of utilities, temperature and humidity monitoring systems and other operational parameters to ensure a GMP-compliant environment for stability studies.
TABLE OF CONTENT
| Description | Page No. |
| Title Page | |
| Table of Contents | |
| Pre – Approval of Documents | |
| Objective | |
| Scope | |
| Responsibilities | |
| Critical Attributes to be met while operating facility | |
| General observation Checklist for Operational Qualification | |
| Operational Specifications (Area Wise) | |
| Summary and Conclusion for Operation 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 |
Operation Qualification of Stability Area: Objective and GMP Requirements
This document is generating under the authority of the XYZ Company for the purpose of specifying the Operation Qualification for Stability Area. To establish documented evidence that the Stability Area infrastructure, utilities, and environmental conditions are installed correctly and operate as intended (Operational Qualification) in compliance with predefined specifications.
Scope:
The scope of this document is to define the requirements for Stability Area in XYZ company.
Responsibilities
| Department | Responsibility |
| Quality assurance | Preparation of Operation Qualification protocol cum report Execution of Operation Qualification Review of OQ Pre & Post Approval of OQ Responsible for the compliance of OQ |
| Engineering | Review of OQ Support in execution of Operation Qualification To assist concerned department for the preparation of OQ |
Operation Qualification of Stability Area: Facility Installation Operation Brief Description
The Stability Area facility is designed, installed & operated to support stability of finish product in compliance with applicable regulatory requirements.
The Operation includes:
Facility Layout & Segregation:
The Stability Area is be properly organized and operatable. 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 operational:
Essential utilities including electrical supply, purified water system (if required), and HVAC/Air conditioning systems are operated as per design specifications.
Safety Systems:
Fire extinguishers is verified and in operation
Documentation:
Availability of equipment manuals, calibration certificates, SOPs, and layout drawings is ensured.
Operation Qualification of Stability Area: Critical Attributes to be Met While Operating Facility
The following attributes must be controlled and verified during operation:
Environmental Conditions
- Temperature maintained within specified limits (NMT 25°C)
- Continuous monitoring and recording
HVAC Performance
- Airflow and ventilation effectiveness
- Air changes per hour (ACH) as per requirement
- Pressure differentials (if applicable)
Utility Performance
- Continuous and stable electricity supply
- Consistent quality of water.
Safety Compliance
- Emergency equipment readily accessible and operational
General Observation Checklist for Operation Qualification
| Objective | Observation |
| Cleaning & Sanitization SOP | |
| EM monitoring SOP | |
| PM SOP for utility system | |
| Utility Qualification SOP | |
| Defined Area Classification | |
| Completion of Installation Qualification |
Operational Specifications (Area Wise)
Section usually lists the 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.
| CHECK POINTS | REQUIREMENT |
| Description | |
| Access control (If required) | Access control should be installed and in operation |
| Identification | |
| Area Finish | |
| Area floor cleaning | Should be Neat and clean |
| Area Status Label | Area Status label should be affixed |
| Panel/wall Surface finish and cleaned | Pane surface should be finished and cleaned |
| Sand coving surface finished and cleaned | Should be finished and cleaned |
| Area View Panel Surface finished & Cleaned | Should be finished and cleaned |
| 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 | Coving should be smooth and cleaned |
| Doors of Area & Air lock: | |
| Door View Glass and all parts cleaned | Should be cleaned |
| Direction of door as per drawing | Should be as per drawing |
| Door should be opened up to 90o angle | – |
| Door should be open without any obstruction | – |
| Door closed after release without push | – |
| Door interlocking working in place (If any) | – |
| Room ID affixed on door | – |
| Electrical Works: | |
| Electric switches are working properly | – |
| Switch sockets are working properly | – |
| 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 | – |
| Number of polychromatic/sodium lights of area as per drawing | – |
| Location of the connections and its voltage and phase. | Connections should be concealed |
| Size of polychromatic/sodium 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/Air conditioning system of Area | |
| Check the working of Air conditioning unit | – |
| Services/Utilities: | |
| Machine Utility Supply Line with LAN cable availability | Required and supply line & LAN should be concealed |
| Compressed Air line availability (if any) | – |
| Power plugs and sockets | Should be concealed |
| Process water supply line (if any) | – |
| Purified water supply loop (if applicable) | Purified water line should be available and marked |
| UPS system availability (if required) | – |
| 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. | – |
| Availability of SOP stands | For SOP display in area |
Summary and conclusion for Operation Qualification
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Abbreviations
| cGMP | Current Good Manufacturing practices |
| URS | User Requirement Specification |
| GMP | Good Manufacturing Practices |
| UPS | Uninterrupted power supply |
| NMT | Not more than |
| LED | Light Emitting Diode |
| WHO | World Health Organization |
| ICH | International Council for Harmonisation |
| IOQ | Installation Operation Qualification |
| DQ | Installation Operation Qualification |
| SS | Stainless Steel |
| LAN | Local Area Network |
Reference
- EU GMP Part 1 chapter 6
- WHO Technical Report Series 961 Annex 9
Post Approval of Documents
CHECKED BY:-
| Name | Designation/Department | Signature | Date |
REVIEWED BY:-
| Name | Designation/Department | Signature | Date |
APPROVED BY:-
| Name | Designation/Department | Signature | Date |
Revision History:
| Revision No. | Effective Date | Nature of revision |