FASSGEN PHARMACEUTICALS (PVT.

) LIMITED
Operational Qualification

Heat Ventilation & Air Conditioning (HVAC) System

Operational Qualification Protocol of:
(Unit No. 06)

Operational Qualification Protocol No. : (OQ-06)

(Not Valid Without Signature)

Personnel Involved in
Signature / Date Designation
Qualification Study

Muhammad ALI
ELECTICAL ENGINEER

Prepared By:

IMRAN KHAN
Manager Engineering

Reviewed By:

SYED WAQAR SHA

Production manager

Checked By:

ZEESHAN

PRODUCATION OFFICER

APPROVED BY

1.0 Operational Qualification:

FASSGEN PHARMACEUTICALS (PVT.) LTD. Hattar

 FASSGEN PHARMACEUTICALS (PVT.) LIMITED
Operational Qualification

Operational Qualification (OQ) should be performed after satisfactory compilation of the Installation Qualification (IQ).
Any Worst Case challenges to the HVAC System are defined and incorporated into the testing strategy and should be
mentioned in the Operational Qualification Report.
The SOP’s for the operation, maintenance, cleaning/ sanitization, calibration and safety must be available during Operational
Qualification.

2.0 Objective:

To established a documented evidence that the HVAC System operates according to predetermined design, functional and
operational specifications and suitable for intended purpose and will produce consistent and reliable results/ output.

3.0 Scope:

The scope of the activity of Operational Qualification of HVAC System is to ensure that,
i. The operation of the HVAC System is in accordance with the pre-determined specification provided either by the
manufacturer or the user specification/ requirements.
ii. To perform systematic check for the proper working of all major components of the HVAC System according to
predetermined checking criteria.
iii. To ensure availability of all the utilities according to requirement.
iv. To ensure the availability of the Standard Operating Procedure (SOP) including responsibilities, cleaning, operating,
calibration and maintenance procedures.
v. To establish the operational qualification report including observation, deviation encountered during qualification
study and impact of deviation, corrective action to be taken in response of any deviation and finally the conclusion
either the HVAC System qualifies its operation or not.

4.0 Change Control:

Any modification, fabrication or relocation of HVAC System which directly or indirectly affects the performance of the
Blistering or the quality of the product should be controlled and in accordance with the Change Control Procedure and it will
be required to re-qualify the HVAC System.
Minor changes or the changes have no direct impact of the in process or final product quality should be handled through the
system of the preventive maintenance program.

5.0 Responsibility:

a. Deputy Manager Validation

b. Assistant Officer Validation
c. Engineering Department
d. Quality Assurance Department

6.0 Requirement:

FASSGEN PHARMACEUTICALS (PVT.) LTD. Hattar

 FASSGEN PHARMACEUTICALS (PVT.) LIMITED
Operational Qualification

i. Description of the HVAC System to be studied for OQ along with actual mechanism of work and functions.
ii. Actual results, the predetermined functional and operational specifications during rest conditions.
iii. Working mechanism of the major components.
iv. Specification of the supporting utilities.
v. Calibration results of the parameters that required calibration along with calibration frequency (if applicable).
vi. Environment, safety and health aspects (safety Features).

7.0 Operation/Procedure:
The HVAC System has the following parameters that required calibration;
Air Quantity Supplied
a. Measure the Air Velocity with the pre calibrated Climomaster (Velocity Meter) by proper positioning of the Hood for the
air supply diffuser.
b. Take measurement for a minimum of 05 seconds in one position and record the reading.
c. When air velocities fall below the lower limits (as per room requirements), the pre-filters should be checked / Cleaned
(as required) and replaced if exceptionally dirty. If the average air flow velocity is still below the lower limit, increase the
blower speed until the acceptance Criterion is met. When the blower speed control is turned to the maximum setting
and the average airflow velocity is below the recommended value, assess the need for the blower repair and filters
replacement.
d. If blower motor is repaired or filter replacement is necessary, repeat the above steps. Report all the results on the
certification report form.
Air Changes Per Hour Calculation
a. Using the above data of air quantity in cubic feet per minute (CFM), calculate the air changes per hour (ACH) of
individual rooms using the following equation.
Air Quantity (CFM)
Air Changes Per Hour (ACH) = x 60
Room Volume (Ft3)
Air Flow direction and Room Pressurization
a. After adjusting the individual air flow in the supply diffuser, monitor the differential pressure of each room using the
differential pressure gauge installed at the entrance of each room.
b. The differential pressure gauge of each of room should give negative pressure with respect to the adjacent corridor.
c. If the differential pressure is not as per requirement, adjust the air supply using dampers, fresh air supply in the unit and
return air from individual rooms.
Temperature & Humidity
a. Monitor and check the temperature and humidity of the rooms using the pre-calibrated Climomaster or hygrometer, by
holding the Probe in atmosphere for few seconds.
b. In case the Relative Humidity / Temperature are outside the predetermined limits adjust them with the adjustment of
steam or cooling coils.

FASSGEN PHARMACEUTICALS (PVT.) LTD. Hattar

 FASSGEN PHARMACEUTICALS (PVT.) LIMITED
Operational Qualification

8.0 Check List:

S. No. Check Points / Detail
Check and ensure that the SOP of the HVAC System is available and fulfill the requirements i.e. Operating;
1. Cleaning and Calibration Procedure (if required) are mentioned along with Environment, Safety and Health
precautions.
2. Ensure the safe and appropriate working of electric switches.
3. Verify the predetermined specification of the HVAC System.
4. Ensure the system is closed and there is no leakage. All the valves and connection are sealed properly.
5. Ensure the proper operation of supply Fan and Dampers.
6. Check the connections of all the required utilities.
7. Check and ensure the proper working of all the components one by one.
8. Ensure the proper working of Control Panel.
9. Verify the function of menu selection according to procedure mentioned in the manual.
10. Verify the Span of Calibration & Manual Calibration procedure as mentioned in the manual.
11. Ensure the availability of the Master Calibrator for the Calibration of different parameter.
12. Check and ensure the availability and proper working of safety switches and alarms.
13. Ensure the proper working of the pressure gauges/temperature gauges/ safety valves.
14. Ensure that the air pressure is supplied according to specification.
15. Make it sure that the flow of air is unidirectional i.e. Laminar Flow.
16. Check pressure differential manometers are installed on the Air Handing Units (HVACs)
Ensure the Periodic monitoring is carried out to detect any significant changes in air velocity/differential pressure
17.
from the normal level.
Ensure the maintenance records showing that the system has been properly maintained. Personnel training,
18.
showing that human resources are at hand to properly operate and maintain the system.

FASSGEN PHARMACEUTICALS (PVT.) LTD. Hattar

 FASSGEN PHARMACEUTICALS (PVT.) LIMITED
Operational Qualification

9.0 Facilities/Responsible Personnel/Equipment/Material & Documentation:

10.0 Facilities:
The Operational Qualification of HVAC System will be performed in the Compression of General section in
production Department of FASSGEN PHARMACEUTICALS (PVT.) LTD. Hattar -Pakistan.

10.1 Identification of Responsible Personnel:

Name Job Title Signature

WASIF ENGINEER

YUSRA Assistant Officer Validation

Qudsia Numair Manager Quality Assurance

Muhammad ALI Assistant

SIDRA Production Pharmacist

10.2 Identification of Documentation:

Description of Document

Validation Master Plan

SOP For System/Equipment Qualification

SOP For Calibration

Air Velocity & Air Changes Determination

10.3 Other Information:

Manufacturer For:

Local

FASSGEN PHARMACEUTICALS (PVT.) LTD. Hattar