1.0 PURPOSE:
To lay down a procedure for preparation, review and approval of facility qualification document.

2.0 SCOPE:
This procedure is applicable for preparation, review and approval of facility qualification at (Company name).

3.0 DEFINITIONS:
Nil

4.0 RESPONSIBILITY:
4.1 QA Personnel shall responsible for preparation, review and approval of facility qualification protocol.
4.2 Engineering / Projects personnel shall review and execute the facility qualification document, Shall Prepare the Room Data Sheet.
4.3 User shall support during preparation of room data sheet.
4.4 Head – User department, Head – Engineering / Projects and QA Head (or) their respective designee shall review the protocols and reports

5.0 PROCEDURE:
5.1 Qualification Approach
5.1.1 A qualification protocol shall be prepared for each facility to be qualified. The protocol shall outline the test to be performed for qualification with specification/acceptance criteria.
5.1.2 The protocol shall be review executed and reviewed for completion by the designated individuals
5.1.3 All new facility shall be qualified as appropriate before taking it into use.
5.1.4 Addendum facility qualification reports shall be prepared in case of renovation/modification/expansion in the existing facility.
5.2 Facility qualification shall be carried out to evaluate that facility is build as per design specification.
5.3 Verify the details of facility as per facility qualification protocol. Facility qualification protocol shall be prepared as per Annexure: I
5.4 The facility qualification protocol shall contain the following (But not limited to).

5.4.1 Protocol Approval:
5.4.1.1 Prepared by: Person who prepares (validation coordinator) the protocol shall enter name, designation with sign and date.
5.4.1.2 Reviewed by: Person who reviews (user department & Engineering) the protocol procedure shall enter name, designation with sign and date.
5.4.1.3 Approved by: Head – QA or designee shall enter name, designation with sign and date.

5.4.2 Objective
5.4.2.1 An overview of the intent of the protocol shall be briefly mentioned here.

5.4.3 Scope
5.4.3.1 This shall include why the procedure is written and why is it being performed.

5.4.4 Facility Description
5.4.4.1 The description of area / room for which the protocol is limited shall be briefed here.

5.4.5 Test Procedure
5.4.5.1 It shall explain the test procedures to be followed, tools/Equipments required and acceptance criteria for each individual test parameter to qualify the facility.
5.4.5.2 Each test procedure shall be explained in short, unambiguous sentences.
5.4.5.3 The following individual test shall be carried out as a part of facility qualification protocol
5.4.5.4 Verification of Supporting Documents
5.4.5.5 Verification of Area / Room for Construction and Finish
5.4.5.6 Identification and Verification of Utilities Provided
5.4.5.7 Electrical, Communication and Safety Features
5.4.5.8 Verification of Environmental Conditions
5.4.5.9 Verification of Equipment Qualification Status

5.4.6 Recording of Observations
5.4.6.1 Record the observations during execution in “Room Data Sheet” as per Annexures-I and facility qualification protocol as per Annexure-II.
5.4.6.2 Wherever appropriate proper supporting document shall be provided for each test.
5.4.6.3 Room Data Sheet shall be prepared to each room / area during execution of the protocol and attach along with facility qualification report during compilation.

5.4.7 Discrepancy and Corrective Action Report
5.4.7.1 Indicate where the discrepancies should record and explain if any.

5.4.8 Acceptance criteria
5.4.8.1 Under this section the acceptance criteria of each tests should be provided

5.4.9 Compilation, review and summary report
5.4.9.1 Under this section the guidance related compilation and review of summary report shall be provided

5.5 Protocol Numbering System
Each protocol and its report shall be identified through a unique identification number as described below
FQP/XXX/ZZZ-AA
Where,
FQP – Facility Qualification Protocol
XXX – Company name
ZZZ- Sequential No. of facility qualification protocol
AA- is revision number. Protocol prepared for the first time shall be numbered as “00” and continues from “01” onwards.
e.g.: The first facility qualification protocol prepared shall be numbered as “FQP/XXX/001-00”

5.6 Report Numbering System
Report generated for validation protocol shall be identified with a report number having prefix “R” in place of “P” to the respective protocol number.
e.g.: The facility qualification report is prepared against protocol “FQP/XXX/001-00’’ shall be numbered as “FQR/XXX/001-00”
5.7 Facility qualification reports shall be prepared as per Annexure-III.
5.8 The Numbering of the facility qualification protocols and reports be maintained in Annexure-IV.

6.0 ABBREVIATIONS:
6.1 SOP : Standard Operating Procedure.
6.2 QA : Quality Assurance.
6.3 HVAC : Heating, ventilation, and air conditioning

7.0 REFERENCES:
Nil

8.0 LIST OF ANNEXURES:
8.1 Annexure-I: “Room Data sheet”
8.2 Annexure-II: “Template for facility qualification protocol”
8.3 Annexure-III: “Template for facility qualification Report”
8.4 Annexure-IV: “Facility Qualification protocol and report Numbering register”

                                               Annexure-I: Room Data sheet

Maximum Person Allowed:

HVAC System:

Room Classification

:

AHU Type

:

Air Change/Hours

:

Temperature (°C)

:

Nos. of Supply Grills

:

Humidity (%)

:

MOC of Grills

:

Differential Pressure (Pa)

:

Nos. of Returns Risers

:

Nos. of Returns Diffusers

:

Nos. of Supply Diffusers

:

Noise level

:

Electricals:

Type of Electrical Fittings

:

Nos. of Plugs

Single Phase

:

Double phase

:

Nos. of Switches

:

Lux Level (Minimum)

:

Emergency Lamp

:

Nos. of Computers / LAN Connection

:

Nos. of Telephone Points

:

Local Display Unit (LDU)

:

Access Control

:

Public Address System

:

Nos. of UPS connection

:

Sodium Vapour Lamp

:

Inter Locking Details

:

Nos. of Light Fixture

:

Location of light fixtures

:

Static electricity discharge

:

Equipment Power load (KV/KW)

:

Earthing type

:

Manometer/Pressure Differential gauge

:

Civil Details:

Room Size (mm)

:

Length:

Width:

Height:

Area in sq. mtr.

:

Door Size (mm)

:

Length:

Width:

Height:

Size of Window

:

Length:

Width:

Height:

Wall Finish

:

Thickness of wall

:

Painting on wall & Ceiling

:

Floor Finish

:

Presence of False Ceiling

:

MOC of false ceiling

:

Partition Material

:

Type of Door

:

Nos. of Doors

:

Type of closing/ opening

:

Nos. of Window

:

Type of Window

:

Nos. of Drain

:

Drain type

:

Type of sealant

:

Coving Details of  ceiling

:

Pressure bearing Capacity of floor

:

Coving Details of  Wall & Floor

:

Presence of granite slab

:

Dimension of granite slab

:

Safety System:

Nos. of Fire Extinguishes

:

Fire / Smoke Detector

:

Emergency Exit

:

Manual Call Points

:

Telephone connections

LAN connections

Utilities:

Portable Water

:

Chilled Water

:

Purified Water

:

Nitrogen

:

Water for Injection

:

Compressed air

:

Steam

:

Power

:

Any other Process Gas

:

Utility Pendent

:

Vacuum line

Dust Collector

Scrubber

Accessories Details (If any):

Sr. No.

Name of Accessories

Quantity available

Equipment Details:

Sr. No.

Name of Equipment

Make

Model

Equipment Dimension/Size/Capacity

Remarks:

­­

Prepared By: Date:

Checked By: Date:

Approved By: Date:

                            Annexure-II: Template for facility qualification protocol

Department name	Protocol No.:
Title of protocol	Supersedes.
	Effective Date:
	Page No.

• Table of contents
• Approval signatures
• Objective
• Scope
• Responsibilities
• Reference
• Equipment description
• Equipment identification
• Qualification procedure
• abbreviations   
• revision history

Date of preparation	Revision Number	Change Details	Reason for Revision

                                Annexure-III: Template for facility qualification report                                               

Department name	Report No.:
Title of Report	Ref. Protocol No.:
	Prepared on:
	Page No.

• Table of contents
• Abbreviations
• Objective
• Scope
• Responsibilities
• Reference
• Equipment description
• Equipment identification
• Qualification procedure
• Approval signatures
• Revision history

Date of preparation	Revision Number	Change Details	Reason for Revision

                Annexure-IV: Facility Qualification protocol and report Numbering register

Sr. No.	Facility Name	Protocol title	Protocol number	Report number	Allotted by
					Sign	Date