TEM 180

Issue date

Installation Qualification Operating Environment

(Reference SOP: __________)

Project:

Project No:

Facility Description:
Manufacturer / Builder:

Equipment No:

Location:

Protocol:

PROGRAM INDEX
1.
2.
3.
4.

OBJECTIVE................................ ................................ ................................ ............................. 3

ACCEPTANCE CRITERIA ................................ ................................ ................................ ....... 3
QUALIFICATION PROCEDURES ................................ ................................ ........................... 3
FACILITY ................................ ................................ ................................ ................................ . 3
4.1.
Drawings. ................................ ................................ ................................ ........................ 3
4.2.
Equipment / Components - Manufacturer s Specifications ................................ ............... 3
4.3.
Component Materials (as detailed in design spec.)................................ .......................... 3
4.3.1.

Material of Construction - WALLS ................................ ................................ ............ 3

4.3.2.

Material of Construction - CEILINGS ................................ ................................ ....... 4

4.3.3.

Material of Construction - DOORS ................................ ................................ ........... 4

Material of Construction - FLOORS ................................ ................................ ......... 4

4.3.4.
5 ELECTRICAL INSTALLATION................................ ................................ ................................ . 4
5.1.
Electrical Drawings ................................ ................................ ................................ .......... 4
5.1.1.

Single Line ................................ ................................ ................................ ............... 4

5.1.2.

Cables Schedules ................................ ................................ ................................ .... 4

5.1.3.

Termination................................ ................................ ................................ .............. 4

Control Schematics................................ ................................ ................................ .. 5

5.1.4.
5.2.
Equipment Rating ................................ ................................ ................................ ............ 5
5.3.
Supply Wiring ................................ ................................ ................................ .................. 5
5.4.
Distribution Details................................ ................................ ................................ ........... 5
Instrumentation................................ ................................ ................................ ................ 5
5.5.
5.5.1.

Critical Instrumentation ................................ ................................ ............................ 5

5.5.2.
Non Critical Instrumentation (Convenience) ................................ ............................. 5
5.6.
Spare Parts List Location:................................ ................................ ................................ 6
6. AUXILIARY EQUIPMENT / SERVICES LIST - HVAC................................ .............................. 6
7. ENVIRONMENTAL CONTROL SYSTEMS ................................ ................................ .............. 6
7.1.
Environmental Monitoring: ................................ ................................ ............................... 6
7.2.
SOP s ................................ ................................ ................................ .............................. 6
8. PREVENTATIVE MAINTENANCE ................................ ................................ ........................... 6
8.1.
Preventative Maintenance Program Identification: ................................ ........................... 6
9. SAFETY................................ ................................ ................................ ................................ ... 6
Safety Devices ................................ ................................ ................................ ................ 6
9.1.
Fire Protection System ................................ ................................ ................................ .... 7
9.2.
................................ ................................ .......................... 7
10.
Prepared By:

Date Prepared:

Revision No:
Page of 8

TEM 180
Issue date

Installation Qualification Operating Environment

(Reference SOP: __________)

OBJECTIVE

1.

To provide documented verification that all key aspects of the selection , application, construction and
installation of the facility (description name of the process and system) adheres to appropriate codes,
cGMP s and approved design intentions and that the manufacturers recommendations are suitably
considered.

2.

ACCEPTANCE CRITERIA
A successful completion of the Installation Qualification process are based on the following :
i

All activities listed in Installation Qualification have been executed.

All entries of data have been signed and dated by the person or persons performing the
activity or verification.

All data has been adequately reviewed and reported .

Any discrepancies that have occurred have been satisfactorily resolved and are correctly
signed and dated as resolved.

QUALIFICATION PROCEDURES

3.

The protocol consists of tables containing information that needs verification . The Qualification
inspection and verification process are largely depended on visual inspection, comparison to As Built
drawings and equipment specification as quoted in the protocol .
Any tables or sections not relating to process or equipment should not be deleted and the word N/A
should be used, additional tables or sections can be included.
Other documents that support the Qualification process can be referenced or included as attachments .
All people involved in the Qualification inspection and verification process are required to fill out
section 12 of this protocol.

FACILITY

4.

4.1.

Drawings.

The drawing ID numbers may be included as an Attachment .

Drawings for the rooms and equipment must include the location of the air supply , air returns, sensors and
controls.
Drawing Identification Numbers:______________________
Electronic copy supplied: Yes/No

4.2.

Signed_____________________

Equipment / Components - Manufacturer s Specifications

Provide all specifications for the above. They may be included as an Attachment.
Manufacturer s Specifications provided? Yes/No

4.3.

Signed_____________________

Component Materials (as detailed in design spec.)

List only those Materials detailed in the Design Specification . Include floor, wall and ceiling finishes in the
facility.

4.3.1. Material of Construction - WALLS

Material Specified:_________________________

Prepared By:

Date Prepared:

Revision No:
Page of 8

TEM 180
Issue date

Installation Qualification Operating Environment

(Reference SOP: __________)

5.1.4. Control Schematics

Drawing Identification Numbers:______________________
Electronic co py supplied: Yes/No
Signed_____________________

5.2.

Equipment Rating

Documents must include the voltage, current, power, phases and the main switch location.
Reports/Certificates Provided: Yes / No
Location of Certificates:________________________

5.3.

Signed_____________________

Supply Wiring

Provide a document regarding the type and size for conductor and the connection type . Include any special
type of installation required.
Report Provided: Yes / No
Location of Report:____________________________

5.4.

Signed_____________________

Distribution Details

Main Switchboard:
Sub Board:
Distribution Board:
Circuit Breaker Type:
Circuit Breaker Rating:
Phases:

5.5.

Instrumentation

NB: This information should be located in the HVAC documentation .

Instrumentation details for both Critical and Non-Critical Instrumentation should be supplied. Attach printout
of all items requiring calibration as well as a Preventative Maintenance printout .

5.5.1. Critical Instrumentation

Instrumentation Details provided: Yes / No

HVAC Proto col No.:___________

List of equipments for Calibration and Preventative Maintenance provided : Yes / No

Attachment numbers:__________________

Signed______________________

5.5.2. Non Critical Instrumentation (Convenience)

Instrumentation Details provided: Yes / No

HVAC Protocol No.:___________

List of equipments for Calibration and Preventative Maintenance provided : Yes / No

Attachment numbers:__________________

Prepared By:

Signed______________________

Date Prepared:

Revision No:
Page of 8

TEM 180
Issue date

Installation Qualification Operating Environment

(Reference SOP: __________)
Safety Devices list provided? Yes / No
Attachment No.:______________
Signature_____________________
9.2.

Fire Protection System

Provide detailed documents describing the Fire Protection System . Refer to sprinkler heads used as well as
tests run to show they qualify.
Fire Protection System documents provided ? Yes / No

Attachment No.:______________

Signature______________________

COMMISSIONING OVERVIEW

10.

10.1. Structural
Level

Room _ to Room _

Signed

10.2. Equipment - Doors

Level

Door _

Signed

10.3. Process Operation

List reports completed for leak check of HEPA filters , integrity testing of seals and ductwork, room differential
pressures, filter face velocities and f low balancing.
Include reports as attachments.

10.4. Handover of Specifications

Specifications

File Name(s) in G:\D_Spec\

Completed

User Requirement Specification(s)

Functional Specification(s)
Software Design Specification(s)

Prepared By:

Date Prepared:

Revision No:
Page of 8