Design Qualification of QC- Facility Qualification

Table of Content for Design Qualification of QC- Facility Qualification

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

Objective for Design Qualification of QC- Facility Qualification:

This document is generating under the authority of XYZ company for the purpose of specifying the Design Qualification for new Quality Control 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 Design Qualification is compiled to facilitate prospective suppliers and/or design engineers in understanding the needs, identifying further requirements and proposing a suitable design. The Design Qualification is not intended as an exclusive approach, the identification of omissions or alternative suggestions by prospective suppliers and/or design engineers are welcome.

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 Design Qualification protocol cum report Ø Execution of Design Qualification Review of DQ Pre & Post Approval of DQ Responsible for the compliance of DQ
Engineering	Review of DQ Support in execution of Design Qualification To assist concerned department for the preparation of DQ
Quality Control	Review of DQ To assist concerned department for the preparation & execution of DQ

Facility Design Brief Description:

The new Quality Control (QC) laboratory is designed to perform chemical analysis of raw materials, in-process samples, finished products, stability samples, and packaging materials in

compliance with GMP requirements. The laboratory layout is planned to ensure smooth workflow, segregation of activities, and prevention of cross-contamination.

The facility will include designated areas for sample receipt, wet analysis, instrumental analysis (HPLC, UV, and Dissolution), sample storage, reagent preparation, and documentation. Adequate provisions will be made for ventilation, temperature and control, purified water supply, and appropriate electrical connections for analytical instruments.

The laboratory design will comply with applicable regulatory and safety requirements, ensuring proper personnel movement, material flow, and safe handling of chemicals, solvents, and analytical standards.”

Critical Attributes to be met while Design Qualification of QC- Facility Qualification

Layouts & Design

QC laboratory layout is designed with separate areas for sample receipt, wet analysis, instrumental analysis, reagent preparation, sample storage, and documentation to ensure proper workflow, segregation of activities, and compliance with GMP and safety requirements.

Room list for QC lab includes
Utilities required
HVAC requirements
Safety provisions (fume hood, exhaust, eye wash, etc.).

Location & Surroundings

The laboratory shall be located in a clean and controlled environment away from sources of contamination such as production dust, excessive vibration, and external pollutants.

Premises

The premises shall be designed to provide sufficient space for analytical operations, instrument installation, storage of chemicals, and safe movement of personnel.

Floor

Floors shall be smooth, non-porous, chemical-resistant, and easy to clean. Flooring material shall prevent accumulation of dust and contaminants.

Walls

Walls shall be smooth, non-shedding, and finished with suitable paint or coating to allow easy cleaning and maintenance.

Ceiling

Ceilings shall be designed to prevent accumulation of dust and minimize particle shedding. False ceilings, if provided, shall be properly sealed.

Doors & View Panels

Doors shall be smooth, easy to clean, and self-closing where required. View panels may be provided for monitoring laboratory activities without unnecessary entry.

Utilities to be provided

The following utilities shall be provided in the QC laboratory:

Purified water supply
HVAC
Exhaust systems and fume hoods

Electrical Requirements

Adequate electrical supply with proper earthing, dedicated power points, UPS backup for critical instruments, and voltage stabilizers shall be provided.

Safety Aspects

Safety provisions shall include:

Fume hoods
Fire extinguishers
Safety shower/Eye washer
Spill kits
Emergency exits
Proper chemical storage facilities

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:

Instrument Name	Instrument Name
UV Cabinet	Dissolution Test Apparatus
Centrifuge	UV
Hot Air Oven	Potentiometer Titrator
Vernier Caliper	Sonicator
Disintegration Test Apparatus	HPLC
Friability Apparatus	Sonicator
Muffle Furnace	pH meter &Conductivity meter
Water Bath	Water Purification System
Potentiometer	Water Bath
Fuming hood	Hardness Tester
Karl Fisher Apparatus	Sieve Shaker
Refrigerator	Tapped Density Tester

General Observation Checklist for Design Qualification of QC- Facility Qualification:

Objective	Observation
Adequate space allocation for each testing activity.
Logical workflow from sample receipt → Storage → Testing → disposal
Separate areas for chemical testing, instrumental analysis.
Provision of restricted access to authorized personnel only.
Adequate space for instrument installation and maintenance.
Adequate lighting levels for analytical work.
Proper ceiling and wall finish (smooth, cleanable, non-shedding).
Adequate working space for instruments and analysts.
Provision of emergency exits and safety signs.
Sample receipt area defined and separated.
Dedicated sample storage area (controlled conditions if required).
Stable flooring for heavy instruments.
Separate instrument rooms for sensitive instruments (HPLC, FLD, UV etc.).
Dedicated wet lab area.
Separate balance room with vibration control.
Designated glassware washing and drying area.
Availability of clean power supply for analytical instruments.
Provision for UPS or power backup for critical instruments.
Provision for adequate purified water supply
Proper drain system for chemical waste.
Adequate number of electrical sockets.
Availability of fume hoods for hazardous chemical handling.
Emergency shower and eye wash stations installed.
Availability of fire extinguishers.
Proper chemical spill kits available.
Adequate ventilation for solvent storage areas.
Separate storage for: Chemicals, Solvents, Reference standards, Retention samples
Controlled temperature storage (refrigerators/freezers) where required.
Controlled storage for reference standards.
Separate provision for document storage.
Provision for Server placement.
Secure computer workstations for instrument software.

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Specification (Area Wise) for Design Qualification of QC- Facility Qualification:

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.
Change Room, office, Sample Storage, Cleaned Glassware, Chemical, Washing area, Balance Room, Chemical Lab, Instrumentation Lab

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:

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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
HPLC	High Performance Liquid Chromatography
FLD	Fluorescence Detector
UV	Ultra violet spectroscopy
WHO	World Health Organization
ICH	International Council for Harmonisation
AC	Alternate Current
QC	Quality Control
HVAC	Heating Ventilation and Air Conditioning
DQ	Design Qualification

Reference

EU GMP Part 1 chapter 6

Post Approval of Documents

CHECKED BY:-

Name	Designation/Department	Signature	Date