Auditing of HVAC System &

Water system
Prepared by: Meenakshi .M. Pandey
Enroll No. : 05
Guided by : Dr. Amit .J. Vyas
M pharm: sem II

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Contents
• Introduction of HVAC
• Audit of HVAC
• Checklist of HVAC
• Introduction to water system
• Audit of water system
• Checklist of water system

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Introduction of HVAC :-
 Heating Ventilation and Air Conditioning
system(HVAC)
WHAT IS HVAC :-
 HVAC systems control the ambient environment
(temperature, humidity, air flow)

 The goal of the heating, ventilating, and air conditioning

(HVAC) system is to create and maintain a comfortable
environment within a building.

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IMPORTANCE OF HVAC :-
HVAC system is responsible for regulating the environment
surrounding your equipment . As the outer weather changes
, the environment in which your equipment is housed will
also change .

• What is an HVAC audit :-

• In HVAC audit there is a component-by-component &
system-by-system evaluation of all HVAC system.
• An HVAC audit focuses on making things work properly
and efficiently.

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Why to perform HVAC audit ?
1. To maximize energy effiency & minimize loss
2. To maximize & protect the health & productivity of the buildings
occupants
3. To convince the controllers of the purse string to pony up for
improvements
4. To determine the buildings overall value
5. To keep up with rapidly changing government guidelines

How to perform HVAC audit:-

• Gather data
• Analyze data
• Collect reccomendations

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SR. AUDIT CHECKLIST FOR HVAC SYSTEM
A GENERAL COMMENT
1. Do
1 they have an air supply filtered by HEPA terminal filter in
each areas ?
2. Is1 the filters efficiency is adequate for such classes?

3. Do
1 storage areas have high efficiency filters? Is the filters
efficiency is adequate for such classes?
4. In
1 the areas of controlled environment , is the number of air
Changes by hour is sufficient for such areas?

5. Are the integrity and the sealing of the filters confirmed?

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SR. NO. AUDIT CHECKLIST FOR HVAC SYSTEM COMMENT

6. Is there a SOP for the review and changing of

filters? Are there records?

7. Is there ventilation with adequate temperature, humidity, and

air filtration, if the raw materials and/or handled products
require it?
8. Do the air flow patterns prevent contamination?

9. Is there an alarm system that indicates a deviation in the air

supply to the aseptic areas?
10. Is there a SOP for how to proceed in the event that occurs?

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SR. AUDIT CHECKLIST FOR HVAC SYSTEM COMMENT
NO.

11. Are there air locks between different classes?

12. Are the toilets air not returned or mixed with production air?

13. Are the temperature and relative humidity measured and recorded?

14. Are pressure differential values in the different areas measured and
recorded? Are records kept?
15. Are particulate counts conducted in the controlled environments?
Are records kept?

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SR. COMMENTS
NO.
AUDIT CHECKLIST FOR HVAC SYSTEM
16. Are microbiological controls conducted in the controlled
environments? Are records kept?
17. Is the frequency for performing the test in different classes
suitable?

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 Introduction of Water system :-
• Water is used as ingredient or a solvent in the processing ,
formulation, & manufacture of pharmaceutical products , API or as a
analytical reagent
 Why Water system audit is done :-
• To identify the quality of water
• To identify each point of water use within & around the facility &
estimate the quantity of water used at each of these points
How to perform audit :-
• Gather data
• Analyze data
• collect Reccomendations

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SR. AUDIT CHECKLIST FOR WATER SYSTEM COMMEN
NO T
.
1 What is the source for the plant water (city or private supply – well
ground water,
or surface water)?
2 Is source water entering the facility tested for chemical
contamination, or are
municipality reports provided?
3 Does the IQ protocol include the review of facility and
specifications of equipment like its design, welding roughness on
pipelines, dead points or sections in the pipelines?

4 Please specify the water whether Phase 1, Phase 2 and Phase 3

studies carried out in at PQ stages? 11
SR. AUDIT CHECKLIST FOR WATER SYSTEM COMMEN
NO. T
4.1 Phase 1 : Whether the operations parameters, cleaning and
sanitation procedures & frequencies defined.
Whether daily sampling records for every pretreatment point and
usage point for a period of 2 to 4 weeks maintained and SOP‘s
prepared
4.2 PHASE 2 : Whether daily sampling records for every pretreatment
point and usage point for a period of 4 to 5 weeks after Phase 1
maintained and reviewed.
4.3 PHASE 3 : Whether weekly sampling records available of every
usage point for a one-year period.

4.4 In the case of water for injections systems, are the daily sampling
records of at least one usage point available, with all the usage
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points sampled weekly?
SR. AUDIT CHECKLIST FOR WATER SYSTEM COMMENT
NO.

5 Is the water prepared by distillation or reverse osmosis?

6 Is endotoxin testing performed on the tank, pre/post-final

treatment step and
points of use?
7 Is the system in a state of control and producing water of a
quality suitable
for its intended use?
8 Are there any personal training records

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SR. NO. AUDIT CHECKLIST FOR WATER SYSTEM COMMENT

9 Is the design for water for injection system adequate for

supplying enough water of pharmacopoeial quality

10 Is the holding tank for WFI system fitted with sterilizing

grade vent filter which is integrity tested?

11 Is the WFI held at more than or equal to 80oc when stored

on continuous circulation?

12 Are limits for microbes and physical and chemical

characteristics established for water systems?

13 Are measures taken when the limits exceed for water

system?
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• REFERENCES :-
• pharmaceutical process validation an international 3 edition marcel
decker series page no . 459

• http://www.goodway.com/hvac-blog/2008/12conducting-an-hvac-
audit.

• http://www.ivtnework.com/article/auditors-pocket-checklist-
pharmaceutical-water-systems

• http://ichapps.com/qms/view/gmp-audit-checklist-for-water-supply-
system

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