Microbiology Laboratory Design Qualification is to ensure that the microbiology laboratory is designed as per GMP requirements. It verifies that the laboratory layout, HVAC system, utilities, man-material flow, and environmental controls are suitable for performing accurate and reliable microbiological testing.
Read Also :- Facility Design Qualification- Complete process with cGMP
TABLE OF CONTENT
| Description | Page No. |
| Title Page | |
| Table of Contents | |
| Pre – Approval of Documents | |
| Objective | |
| Scope | |
| Responsibilities | |
| Facility Design Brief Description | |
| Critical Attributes to be met while designing facility | |
| Layouts & Design | |
| Location & Surroundings | |
| Premises | |
| Floor | |
| Walls | |
| Ceiling | |
| Doors & View Panels | |
| Utilities to be provided | |
| Electrical Requirements | |
| Safety Aspects | |
| Regulatory Requirements | |
| Equipment’s | |
| Observation (Section Wise) | |
| Specification (Room wise) | |
| Summary and conclusion | |
| Abbreviations | |
| References | |
| Post Approval of Documents | |
| 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 |
Objectives for Microbiology Laboratory Design Qualification: Facility Requirements and GMP Compliance:
This document is generating under the authority of the XYZ company for the purpose of specifying the Design Qualification for New Micro Lab. The objective of this document is to provide the requirement and appropriate design to support the in-house requirements as well as compliance with cGMP and to fulfill market demand.
The purpose of this Design Qualification (DQ) Protocol is to verify and document that the proposed design of the Microbiology Laboratory facility is suitable for intended pharmaceutical microbiological testing activities and complies with applicable GMP, safety, engineering, and regulatory requirements
Scope:
The scope of this document is to define the requirements for new Microbiology lab.in XYZ company..
Responsibilities
| Department | Responsibility |
| Quality assurance | Preparation of Design Qualification protocol cum report Ø Execution of Design Qualification Ø Review of DQ Ø Pre & Post Approval of DQ Ø Responsible for the compliance of DQ |
| Engineering | Ø Review of DQ Ø Support in execution of Design Qualification Ø To assist concerned department for the preparation of DQ |
| Quality Micro | Ø Review of DQ Ø To assist concerned department for the preparation & execution of DQ |
Microbiology Laboratory Design Qualification: Facility Design Brief Description
The proposed Microbiology Laboratory is intended for microbiological testing of pharmaceutical products, raw materials, water samples, environmental monitoring samples and in-process materials.
The laboratory shall be designed to:
- Maintain appropriate environmental conditions
- Minimize contamination risk
- Provide segregation of activities
- Ensure safe handling of microorganisms
- Support GMP operations
The laboratory may include the following functional areas:
- Personnel entry/change room
- Sample receiving area
- Media preparation room
- Sterilization/autoclave room
- Sterility testing room
- Environmental monitoring room
- Incubation room
- Culture storage area
- Washing area
- Instrument room
- Documentation area
- Waste disposal area
The design shall ensure:
- Unidirectional flow of personnel and materials
- Controlled access
- Appropriate pressure differentials
- Smooth cleanable finishes
Adequate utilities and safety provisions
Microbiology Laboratory Design Qualification Critical Attributes to be met:
Layouts & Design
Layout is designed to ensure logical workflow and contamination control. Unidirectional personnel flow and material flow with no cross movements shall be provided. Clean and dirty areas shall be segregated. Sufficient operational space shall be provided. Airlocks shall be provided wherever required and dedicated sampling area shall be provided.
Location & Surroundings
Location and surroundings shall be designed to ensure minimizes contamination risk. The location of the micro lab shall be away from the dust and open drains. There will be controlled access available and the area shall be free from excessive vibration and noise.
Premises
To ensure premises are suitable for microbiological operations. Room dimensions shall be adequate for operation and cleaning.
Floor
Floor surface shall be smooth, non-porous and finished, suitable for cleanroom. Rounded coving shall be provided which is easy to clean.
Walls
Walls material shall be suitable for controlled environments which shall be non-shedding and durable having sealed joints and resistant to cleaning agent.
Ceiling
Ceiling design shall be flush sealed which prevents contamination. Lights fitting shall be flush mounted and properly sealed. Cleanability shall be smooth and washable.
Doors & View Panels
Door material shall be non-corrosive and cleanable with self closing doors with interlocking provided (wherever applicable). View panel shall be flush mounted with proper door sealing and drop sealing available.
Utilities to be provided
Utility requirements shall be adequately addressed with proper HVAC, controlled environment monitoring. Purified water and compressed air line shall be made available wherever applicable.
Electrical Requirements
Adequate and safe electrical system shall be available with stable power supply. UPS backup shall be provided with critical equipments wherever required. Adequate quantity of sockets shall be provided and concealed and protected routing of cabled shall be available.
Safety Aspects
Safety provisions shall includes fire extinguisher shall be installed wherever applicable. Emergency exits shall be clearly marked. Biosafety cabinet shall be installed wherever applicable.
Regulatory Requirements
The design of the QC laboratory shall comply with applicable regulatory guidelines such as:
- WHO GMP
- Schedule M
- ICH guidelines
- Other applicable regulatory authority requirements.
Equipment’s
The QC laboratory shall accommodate instruments such as: LAF, Incubators, Autoclave, Deep Freezer, Microscope etc.
Observation (Section Wise)
| Objective | Observation |
| Approved layout available | |
| URS reviewed and incorporated | |
| Personnel/material flow defined | |
| Segregation of clean/dirty areas ensured | |
| HVAC zoning defined | |
| Pressure differentials identified | |
| Utility requirements identified | |
| Floor finish suitable | |
| Walls smooth and cleanable | |
| Ceiling sealed and flush | |
| Doors self-closing | |
| View panels flush mounted | |
| Drainage adequate | |
| Safety systems provided | |
| Fire protection available | |
| Equipment layout finalized | |
| Maintenance access available | |
| Cleaning accessibility ensured | |
| Environmental monitoring points identified | |
| Regulatory requirements considered |
Remark:___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Specification (Room Wise)
Section usually lists the design requirements and specifications for each functional area of the facility, system, or equipment. This helps verify that the design meets regulatory, user requirement specification (URS), and GMP requirements.
Microbiology Laboratory Design Qualification Checklist–Change Room, Media Prep. Room, Autoclave, Incubators room, Media Storage
| CHECK POINTS | REQUIREMENT |
| Description | |
| Check the dimension of the room (length, width, and height in meters / metric system). | Drawing should be available |
| Identification | |
| Walls/Panels of Area & Air lock | |
| Wall/Panel in area. | Availability of wall/Panel in area. |
| Appropriate walls paint (quality, colour, grade) (if any) | Suitable paint depending on wall type (if any) |
| Panel to panel coving with PP strips | Availability of PP strips coving |
| Coving in respective area done. | Coving should be available |
| PP strips coving with silicon work finish | PP strip coving should be available |
| Wall to floor coving with sand coving | Coving should be available |
| Floors of Area | |
| Ensure floor to wall corners have cove | Coving surface should be smooth |
| Ensure that floor is cleaned | Floor surface should be clean |
| Ceiling of Area & Air lock: | |
| Verify the appropriate ceiling of the area. | Ceiling should be available |
| Ceiling to panel/wall coving with PP strips | Coving should be available |
| Doors of Area & Air lock: | |
| Availability of doors in each area. | – |
| Check that proper direction stickers are provided in all door i.e, (Push and Pull). | – |
| Door view glass availability | Door view glass should be available |
| Door Closer | Should be available |
| Door SS handle | Should be available |
| Door electric magnet (if interlocking in place) | Should be available |
| Door air seal | Should be available |
| Door base air seal (Drop Seal) | Should be available |
| Panel/View Panel/window of Area | |
| Ensure that it is properly sealed to prevent dirt accumulation. | Panel/View Panel/window should be sealed |
| 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 |
| Availability of windows | – |
| Electrical Works: | |
| Wiring of Area: | |
| Availability of Electric switches at respective location | – |
| Verify all the electrical cables present in the room are concealed. | Electrical switches should be concealed |
| Lighting of Area & Air lock | |
| Availability 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 | – |
| Electrical switches/sockets available | Electrical of switches should be available |
| Air Handling System of Area & Air lock: | |
| Availability of Supply grills in area | – |
| Availability of Return grills in area | – |
| Services/Utilities: | |
| Machine Utility Supply Line Availability | Should be available |
| Compressed Air line availability | – |
| Availability of Power plugs and sockets | Should be available |
| Process water supply line | – |
| Purified water supply loop (if applicable) | Purified water line should be available and marked |
| Drains: | |
| Availability of drain points (If required) | – |
| General Requirement : | |
| Man movement and Material Flow: | |
| Availability of entry and exit for man and material flow. | – |
| Pass Box | |
| Availability of pass box and its type static or dynamic as per requirement.(If applicable) | – |
Summary and conclusion
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Abbreviations
| cGMP | Current Good Manufacturing practices |
| URS | User Requirement Specification |
| HVAC | Heat Ventilation & Air Conditioning |
| GMP | Good Manufacturing Practices |
| UPS | Uninterrupted power supply |
| NMT | Not more than |
| LED | Light Emitting Diode |
| PUF | Polyurethane Foam |
| PP | Poly Propylene |
| ICH | International Council for Harmonization |
| AC | Alternate Current |
| QM | Quality Micro |
| HVAC | Heating Ventilation and Air Conditioning |
| DQ | Design Qualification |
Reference
- EU GMP Part 1 chapter 6
- WHO Technical Report Series 1019 Annex 7
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 |