The document discusses quality assurance maintenance of HVAC systems. It describes the importance of regularly maintaining HVAC systems to ensure consistent performance and longevity. Key aspects of HVAC maintenance include inspecting and changing air filters, cleaning debris, checking refrigerant levels, and lubricating moving parts. The document provides tips for maintenance schedules and lists 30 points to check during maintenance.
Auditing of critical parameter:- HVAC(heating, ventilation and air conditioning system) 2021; In these presentation includes the requirement of HVAC, Auditing of HVAC components, technical analysis of HVAC components, WHO-GMP audis of HVAC then
Rogert william statement on HVAC, working of HVAC systems and their components Core function of HVAC, Market trends and market analysis of HVAC, WHO guidelines on HVAC system.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
Auditing of critical parameter:- HVAC(heating, ventilation and air conditioning system) 2021; In these presentation includes the requirement of HVAC, Auditing of HVAC components, technical analysis of HVAC components, WHO-GMP audis of HVAC then
Rogert william statement on HVAC, working of HVAC systems and their components Core function of HVAC, Market trends and market analysis of HVAC, WHO guidelines on HVAC system.
Role of quality system and audits in pharmamaceuticalganpat420
Introduction
cGMP Regulations
Quality Assurance Function
Quality Systems Approach
Management Responsibilities
Resources
Manufacturing Operations
Evaluation Activities
Transitioning to Quality Systems Approach
Audit Checklist for Drug Industry
Role of quality systems and audits in pharmaceutical manufacturing environmentMalay Pandya
By regulation, appropriate practice, and common sense, quality assurance (QA) is a critical function in the pharmaceutical manufacturing environment. The need for an independent unit to audit and comment on the appropriate application of standard operating procedures, master batch records, procedures approved in product applications, and the proper functioning of the quality control (QC) unit is paramount.
This helps assure that products are manufactured reliably, with adherence to approved specifications, and that current good manufacturing practices (cGMP) are maintained in conformance to regulation, both in the facility in general and the microenvironment of each product ’s manufacturing sequence.
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
Qualification of Pharmaceutical Manufacturing equipments is covered within the slides, what are the essential aspects to be carried out for the manufacturing purpose.
What is IPQC & IPQC Test
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Installations require regular maintenance, especially when it comes to HVAC systems. Heating and air conditioning service when not maintained or cleaned over the period, its performance starts to slip, and eventually, the entire system fails.HVAC cleaning is crucial if one doesn’t plan on breaking their bank on heating system replacements. Regular maintenance ensures HVAC delivers consistent and uphold performance with an enhanced lifespan of the system.
Essential HVAC-R Maintenance Tips for Optimal Performance and Longevitypbearmaintenace
Maintaining your HVAC-R (Heating, Ventilation, Air Conditioning, and Refrigeration) systems is crucial for ensuring their optimal performance and extending their lifespan. Regular maintenance not only enhances the efficiency of these systems but also helps in preventing unexpected breakdowns and costly repairs. Here are some essential tips to keep your HVAC-R systems in top condition.
A vendor audit is a vehicle used by pharmaceutical companies, and other large companies as well, to inspect and evaluate a vendor’s quality management system, as well as its practices, products, and documentation.
The need to conduct vendor audits stems from a higher need for quality control in an industry that needs to be more regulated than any other industry in the world.
Reason why organizations use audits is to reduce cost and improve quality control
The objective of vendor audit is to develop an audit function comprising of qualified resources to effectively perform compliance audits to ensure that the contracts are being executed in accordance with the intent and address the net benefit to include cost recoveries, process improvement savings, fraud improvement and identification of hidden risks.
In order to reduce the cost pharmaceutical companies have increasingly become dependent on their supplier/ out sourcing partners for customer success. Though it has drastically reduced the production cost for companies, there is a heightened supplier risk and lack of visibility into supplier processes.
To gain an insight into supplier process and eliminate the risks, FDA encourages companies to conduct GMP supplier audit at the manufacturing premises of the supplier.
According to GMP code, it is sole responsibility of pharmaceutical industry to ensure that the suppliers manufacturing process, analytical tests and examinations are carried out reliably by the supplier and are in compliances with the applicable standards and regulations.
After the audit supplier must provide an appropriate corrective action plan with measures that that will be implemented by the supplier within a defined time frame to the manufacturer.
Qualification of tablet compression machinePritam Kolge
Qualification of Tablet Compression Machine ...
This topic comes under Quality Control and Quality Assurance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Introduction
#Design Qualification
#Installation Qualification
#Operational Qualification
#Performance Qualification
#Case Study
#Conclusion
#References
Thanks For Help and Guidance of Dr. Mrs. N. M. Bhatia Mam
As the audit proceeds, there might arise some situations where the facts indicate there is a failure, either partially or wholly, of the quality management system, such a situation is called nonconformity/ deficiencies”.
Equipment used in pharmaceuticals dosage form manufacturing need to observe continuous qualification to monitor its performance and Concept of URS ,DQ, IQ,OQ,PQ,MQ...
Qualification of Pharmaceutical Manufacturing equipments is covered within the slides, what are the essential aspects to be carried out for the manufacturing purpose.
What is IPQC & IPQC Test
Appearance
Drug content determination
pH
Sensitivity test
Spreadability
Rate of absorption
Extrudability
Consistency Test
Rheology & Viscosity
Installations require regular maintenance, especially when it comes to HVAC systems. Heating and air conditioning service when not maintained or cleaned over the period, its performance starts to slip, and eventually, the entire system fails.HVAC cleaning is crucial if one doesn’t plan on breaking their bank on heating system replacements. Regular maintenance ensures HVAC delivers consistent and uphold performance with an enhanced lifespan of the system.
Essential HVAC-R Maintenance Tips for Optimal Performance and Longevitypbearmaintenace
Maintaining your HVAC-R (Heating, Ventilation, Air Conditioning, and Refrigeration) systems is crucial for ensuring their optimal performance and extending their lifespan. Regular maintenance not only enhances the efficiency of these systems but also helps in preventing unexpected breakdowns and costly repairs. Here are some essential tips to keep your HVAC-R systems in top condition.
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Quality assurance maintenance of hvac system in pharmaceutical industry
1. Quality Assurance
Maintenance Of HVAC
System
Prepared By – Shahbaz Nadaf (Student F.Y M.PHARMACY-PQA)
Guided By – Mr.Shakeel Memon
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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2. CONTENTS
• Quality Assurance Maintenance
• Introduction to HVAC
• Importance of maintaining of HVAC System
• What is Involved in HVAC Maintenance?
• When should I do HVAC Maintenance?
• HVAC Maintenance Tips
• HVAC Maintenance Tips To Save Energy and Money
• 30 Point Check List
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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3. Quality Assurance Maintenance
• The Quality Assurance Maintenance (QAM) is responsible for
understanding how and why incidents and errors occur in system
maintenance and support functions, and for instigating remedial
change.
• QAM is also responsible for managing Sentinel, a database of
completed engineering safety reports, which helps to identify
reoccurring errors and failures in practises, procedures and/or
components.
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4. Quality Assurance Maintenance
• QAM designs and implements audit programs to monitor actively
all aspects relating to the compliance of regulatory authorities'
requirements.
• It ensures all applicable elements of the quality system are in
place, documented and implemented effectively to ensure that
the corporate commitment and obligations to regulations, safety
policy and quality standards are followed.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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5. Introduction to HVAC
• Heating, ventilation, and air conditioning (HVAC)
• It is the technology of indoor and vehicular environmental
comfort.
• Its goal is to provide thermal comfort and acceptable indoor air
quality.
• HVAC system design is a subdiscipline of mechanical engineering,
based on the principles of thermodynamics, fluid
mechanics and heat transfer.
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6. Introduction to HVAC
• The HVAC system, like any other installation, requires regular
maintenance and care.
• If you don’t clean and maintain the system, its performance will
start to slip and eventually the entire system will fail.
• This will force you to spend money on heating system
replacement.
• Regular maintenance ensures the HVAC delivers consistent
performance and lasts after a long time.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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8. Importance of maintaining of HVAC System
• Regular maintenance ensures the HVAC delivers consistent
performance and lasts after a long time.
• The HVAC keeps the environment with your property comfortable
and clean.
• The HVAC system filters trap all kinds of dust, debris, germs, and
clean the air.
• They're responsible for maintaining the indoor air quality.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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9. Importance of maintaining of HVAC System
• The HVAC keeps the environment with your property comfortable
and clean.
• It ensures all stale air is recycled and helps maintain the indoor
temperature regardless of the hot or cold climate outside.
• As HVAC is such an important aspect of any residential or
commercial building, it’s important to that invest some time and
money in its maintenance.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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10. What is Involved in HVAC Maintenance?
• Inspecting and Changing Filters
• Visual Inspection of the Entire
System
• Cleaning and Removing Debris
• Checking the Condensate Drain
• Checking the Thermostat Settings
• Checking the Electrical Connections
and Voltage
• Lubricating Moving Parts
• Inspecting Exhaust Outlets
• Checking Fuel Lines and Connections
• Checking the Refrigerant Levels
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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11. 1. Inspecting and Changing Filters
• Filters can get dirty easily, especially if you
live in a location that can be dusty.
• The HVAC system filters trap all kinds of
dust, debris, germs, and clean the air.
• They’re responsible for maintaining the
indoor air quality. If they’re not cleaned and
replaced regularly, your HVAC system will
eventually stop performing as you expect it
to.
• The heating and cooling will be inefficient
and the indoor air quality will worsen.
Inspecting and changing the air filters is one
of the most important aspects of HVAC
maintenance.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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12. 2. Visual Inspection of the Entire System
• You should get your HVAC system visually
inspected at least once every year to make
sure all the systems are working well.
• This inspection is an important aspect of
HVAC maintenance.
• If you don’t get your system inspected, you
won’t notice a problem until it stops working
in the middle of winter. That’s the last thing
you want because you will have to hunt for
alternative heating sources until the system
is repaired.
• Regular inspection and maintenance also
helps keep it in good shape and prolongs its
life.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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13. 3. Cleaning and Removing Debris
• Dust and debris don’t just settle in the
filters.
• They can also collect on blowers, moving
parts, condensing units, and other such
important aspects of your HVAC system.
• A light layer of dust is unavoidable but
too must debris can cause a lot of
damage to the HVAC system.
• A professional will carefully clean all the
accumulated dust and debris and make
sure there’s no corrosive damage to the
internal systems.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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14. 4. Checking the Condensate Drain
• The condensate drain in your air conditioner
and heat pump should be free of all clogs and
debris.
• Clogs can obstruct the flow of condensed
water and cause moisture accumulation within
the system.
• Excess moisture can cause problems like mold,
water damage, high levels of humidity in the
property, uneven temperature regulation,
bacteria, and compromised air quality.
• A professional maintenance technician will
flush and clean the condensate drain to ensure
all excess moisture flows away from the
system.
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15. 5. Checking the Thermostat Settings
• Most HVAC systems now have programmable
thermostats that allow property owners to
control the temperature and set it on a
schedule.
• For example, you can set the thermostat to
lower the heat when you’re not in home to
save money on the energy bills and ensure the
system isn’t overburdened.
• A professional technician will check the
thermostat during the annual maintenance to
ensure the actual temperature and the
temperature on the thermostat matches. If
there’s a difference in the temperature, the
technician needs to check the thermostat’s
performance or assess the entire HVAC system.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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16. 6. Checking the Electrical Connections and
Voltage
• Most people don’t realize that the HVAC
connections and systems can come loose
or break over time. That can
compromise the performance of the
system and eventually damage it enough
that you need to invest in furnace
replacement or AC replacement.
• The maintenance technician will
carefully examine the connections and
evaluate the performance of the system.
They’ll look for frayed and damaged
wires and replace them in order to
minimize the risk of fire and component
failure.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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17. 7. Lubricating Moving Parts
• HVAC systems have moving pasts
in compressors, circulation units, and
furnaces.
• These moving parts need to be
lubricated regularly to minimize friction
and the resultant wear and tear.
• The technicians will carefully clean and
remove all traces of debris from the
moving parts and apply the required
amount of lubricant to control friction.
• This process should be repeated often to
protect the HVAC system from excessive
damage.
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18. 8. Inspecting Exhaust Outlets
• The exhaust outlets allow all dangerous
gases to escape your property so there’s
no risky buildup of carbon monoxide and
other such gases.
• If the exhaust outlets are clogged, they
can lead to a dangerous build-up and
compromise your safety.
• The technician will assess all of these
aspects of your system and check the
chimney flue and vent stack as well.
They will look for signs of corrosion,
leaks, and back draft and repair the
problem during their maintenance runs.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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19. 9. Checking Fuel Lines and Connections
• The fuel lines that supply gas to your furnace
should also be inspected regularly.
• Leaking gas and fuel can be a fire hazard.
• Disconnected fuel lines can compromise the
efficiency of the HVAC system as well.
• Soot can accumulate in burners and
cracked heat exchangers can have an impact
on the system’s efficiency as well.
• The maintenance technicians will assess all
of these aspects of the furnace and carefully
and remove all clogs and traces of soot.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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20. 10. Checking the Refrigerant Levels
• Your air conditioner should have
enough refrigerant in it to cool the
air efficiently.
• If there isn’t enough refrigerant,
the compressor will have to work
harder to achieve the desired level of
temperature.
• That can cause extensive damage to
the system and eventually force you
to replace it.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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21. WHEN SHOULD I DO HVAC MAINTENANCE?
• For a system that heats and cools: perform maintenance in the
spring and fall
• For cooling system maintenance only: perform maintenance at
least once a year, before the cooling season
•
For furnace maintenance only: perform maintenance at least
once a year, before the heating season.
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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22. HVAC Maintenance Tips
• Inspect, Clean, or Change Air Filters Once a Month
• Schedule Seasonal HVAC Maintenance
• Clear the area around your HVAC system
• Clean Evaporator and Condenser Coils (once or twice a year)
• Maximize Air Flow
• Install a Programmable Thermostat
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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23. HVAC Maintenance Tips To Save Energy and Money
• 1.Spring & Summer HVAC Maintenance Tips –
* Change The Air Filter
* Clean The Coils
* Schedule Air Conditioning Maintenance Service
* Consider Replacing Your AC Unit If Older Than 10 Years Old
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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24. HVAC Maintenance Tips To Save Energy and Money
• 2.Fall & Winter Maintenance Tips
* Ensure that your attic is properly insulated
* Weatherstrip any door that leads to the outside
* Clean your chimney (A clean chimney will be safer and will
operate more effectively)
* Test your smoke alarms and carbon monoxide detectors monthly
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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25. HVAC Maintenance Tips To Save Energy and Money
• 3.Furnance & Heater Maintenance Tips
* Heating Tune-Up – schedule maintenance service during the fall to
ensure your kept warm all winter long
* Filters – replace or clean furnace filters monthly
* Clean – keep the heating registers and vents throughout the house
free of dust, dirt and pet hair
Saturday, May 16, 2020ALLANA COLLEGE OF PHARMACY, PUNE
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26. 30 Point Check List
Check system for proper refrigerant
charge
Check heat strip amps Check for excessive vibration
Check compressor amps Check safety controls Level a/c condenser
Check condenser fan amps Check all electrical connections Check defrost control
Check condenser coil Check air circulation Clean, check & adjust condenser fan
Check contactor points Check for air leaks at plenum Check condensing temperature split at
condensing coil
Check capacitor Check all visual leaks Clean indoor blower
Check thermostat (level) Change filter if available Check the crankcase heater
Check thermostat calibration Lubricate all moving parts where necessary Check condenser coil
Check temperature split at evaporator coil Check and clean evaporator coil Check blower amps
Check blower amps Flush or blowout condensate line Check final performance
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