AHU Qualification, HVAC Qualification

AHU Qualification, HVAC System Qualification #validation
AHU Qualification, HVAC Qualification #validation #ahu #hvac @PHARMAVEN #aseptic #pharma
What is Grade A, B, C, D? What is Area Clarification? हिंदी में, #aseptic #quality ‎@PHARMAVEN #gmp
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1. What is Grade A
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3. What is Clean area
4. What is Aseptic area
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हिन्दी में, In Hindi, Importance of Gowning in Clean Rooms @PharMaven #USFDA #pharma #aseptic
Aseptic Area Best Practices for Operators, एसेप्टिक एरिया के ऑपरेटर की ट्रैनिग कैसे करे 👍👍👍
Aseptic Area Best Practices #usfda #pharma #aseptic ‎@Dhavalkumar Surti #gmp #sterilization #aura
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How to Face USFDA Audits GMP
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USFDA How To Behave in Audit Room While Facing Regulatory Inspection
GMP, How To Behave in Audit Room, Facing Regulatory Inspection part 5 #audits #success #PHARMA #GMP
This video is about acceptable behaviour patterns in an audit room, talks about clothing, personal behaviour, do's and don'ts and How to help others during an audit.
How to Face USFDA Audits GMP
USFDA How to Face Audits Questions and Answers 👍👍👍👩‍💼👩‍⚖️
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Part 2 of series About How to Face Regulatory Inspection, this part focused on How to answer questions in regulatory inspection
How to Face USFDA Audits GMP
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How to face USFDA Audit
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Few Insights on How to be Successful in Regulatory Inspection in Pharmaceutical Industry, Mainly on Personnel Practices and Procedures
GMP, How to Face Audits, #pharma #Regulations #audits #success #GMP #PHARMA
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How to face USFDA Audit
How to face Audit
How to be in USFDA Compliance
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#DHAVAL SURTI
Few Insights on How to be Successful in Regulatory Inspection in Pharmaceutical Industry, Mainly on Personnel Practices and Procedures
Few Insights on How to be Successful in Regulatory Inspection in Pharmaceutical Industry, Mainly on Personnel Practices and Procedures

[@isovenu]

Fantastic explanation. God bless your ilk

[@raghavsingh3498]

Amezing

[@dhanrajchaubal5073]

Sir plz make video for facility qualification

[@VikramVikram-db8tp]

Very good

[@mdmhamid]

Thanks a lot sir, very nice video❤

[@waqarali1428]

Thank You Very Very Much Sir, you defined very well, it really helped me to understand the basics of Pharma HVAC system

[@dhirajk2918]

Man gaye guru Great knoweledge sir hope the same knoweledge we acquire in future

[@PHARMAVEN]

Please share to our other Pharma friends to spread Knowledge

[@KolliRajubabu]

Nice subjective presentation sir, thanks for your great efforts to educate Pharma world.

[@miaassociates705]

Very helpfull, Thank You.

[@anaksinha7793]

Thank you sir your explanation was on point

[@PHARMAVEN]

Thanks A Lot Dear Please also share to your friends groups

[@anilnimbalkar6666]

Important knowledge❤❤❤

[@sanchalaldeshmukh6596]

Kindly make video on area classification of clean room and explain each qualification test in sequence

[@vijayjamale2007]

Very nicely explained

[@shubhampawar4741]

Nice video sir..

[@abhishekkumarsingh1288]

NICE VIDEO

[@suresh.sadsul861]

Important and informative video

[@suryaviralshorts]

Too good

[@ManjurAlam-ei2df]

Thanks

[@PHARMAVEN]

Welcome

[@patelutsav4481]

👍

[@abhishekdas-f2d]

Sirji kindly give presentation on pharma artwork handling and guidelines associated with artwork

[@ramakrishnarangisetty6307]

Recovery test we need do dynamics and statics explain sir

[@PHARMAVEN]

Static

[@sachinsharmavadodara]

Nice

[@lonarisanju]

Very nice video Sir

[@PHARMAVEN]

Thanks a Lot Please also share to your friends and groups

[@pravinsingh8170]

Ek sid build candation bhi hota hai

[@yogendrachaudhary9222]

Sir pls explain how to select sample location in NVPC test of AHU

[@Jahid_gamer888]

Hi

[@cadtabhisheksingh6677]

Dry bulb temperature and wet bul temperature kitna hona chahiye?

[@pravinsingh8170]

Sir apne pre filter ke bad kon filter bole the clear bataiye ya screen pe likh diya kijiye

[@LearnValue]

Do we required any system or utility for cold and hot air circulation?

[@PHARMAVEN]

Chilled water/refrigeration and hot water circulation required to maintain temperature and relative humidity. We don’t need to circulate hot and cold air

[@hk-ie7fl]

Sir hvac qualifications and validation both are same

[@PHARMAVEN]

HVAC is qualified

[@ravindrajoshi3374]

During qualification (any) if any discripancy happened, wht kind of QMS document we should follow, because qualification itself is an GMP life time document, we should adress somewhere it's discripancy, which is the best way to come out this.. Some people will say it is non impacting thing, no production is going on, area is still under qualification, so no need to take any kind of QMS document, just by writing down in outcome/conclusion, we can proceed through further by correcting things and qualify the area... so I am confused, which one correct, as I say above, qualification is itself is an GMP document we should adress any discripancy through QMS Document.

[@PHARMAVEN]

Qualification protocol should have a section called Discrepancy which is similar to handling deviations and incidents. Investigation of any Discrepancy to be carried same as deviation/incident Investigation, and CAPAs to be implemented before going for next step. If one wants proceed for next step with open CAPA, a justification and impact assessment should be provided and approved by Quality unit

[@ravindrajoshi3374]

One more question sir... Before any qualification, what we should do 1st, eighter URS, or change control, Or in that change control everything we should include and after approval of change control we should go for full scale qualification. Or can we consider URS as a base document for change control. After approval of URS by management, then we can take change control... Which one is more correct?

[@PHARMAVEN]

For existing Facility, for new Equipment, change control to prepare URS should be taken. For Brand New Facility, URS can be prepared directly. But it is better to first prepare basic SOPs for preparing documents and URS and other Qualification documents. Change control will come in picture once Facility is primary established.

[@PharmGrow]

Completely agree with answers 👍

[@yogendrachaudhary9222]

How to decide the range of DP through magnehelic gauage

[@ashwanimaithani4616]

Sir what isUp stream & down stream

[@ramreshwar198]

Any specific guidelines on this, plz suggest..

[@pushkarrawat5272]

If ACPH not performed during OQ than how can we ensure that AHU is capable to deliver required amount of ACPH before PQ,if not achive during PQ than its lead to deviation.and how can we handle such type of deviation.

[@PHARMAVEN]

Before we go for OQ. Air balancing of area as per design specification has to be done and primary assessment of area in terms of Differential Pressure and air changes. After that one Should go for Qualification

[@lavkushchaudhary6714]

During re qualifications what parameters to be test

[@GulshanJatav-ub6mr]

if any modifications of existing AHU. Viable and non viable particle can I monitoring 1day only

[@PHARMAVEN]

No Three days required

[@GulshanJatav-ub6mr]

@@PHARMAVEN Respected sir please tell me reason why required three day

[@PHARMAVEN]

AHU modification calls for Requalification which is at least three days What modification are you going to do?

[@GulshanJatav-ub6mr]

We are plan to replace EC fan drive, all filters and diffuser

[@pravinsingh8170]

Duct leak limit kitna hai guidelines

[@anayasingh1282]

During autoclave validation how to use thermocouple give brief knowledge

[@PHARMAVEN]

Steam Sterilization; All You Want to Know #sterilization #aseptic #validation #sterile @PHARMAVEN kzbin.info/www/bejne/jJqQdnignqh0rq8

[@pushkarrawat5272]

Sir, ACPH test required during initial OQ of AHU ?

[@pravinsingh8170]

Pre filter pote size sir and fine filter

[@syedmahaboob2502]

Can you please make ఆ video on how to establish online నువపీసీ conters in filling room.

[@PHARMAVEN]

Can you mention English word for Telugu word?

[@syedmahaboob2502]

@@PHARMAVEN Sorry didnt noticed, its online NVPC counters.

[@balramsingh-yt5vf]

Acph ditel

[@shashendrakumararya9063]

How we assure that fresh air is 10% or not, it may be 7% or 8%

[@pravinsingh8170]

Sir kite. Tye ke filetter hepha filete me hote hai

[@shravann_r]

😢

[@bhargavprajapati258]

During filling ,NVPC count of last 35 min data needs to be check in ft cube? Or only excursion count only to be evaluated?