AHU Qualification, HVAC Qualification
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- čas přidán 1. 10. 2023
- 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
2. What is Grade B
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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ऑपरेटर को कैसे ट्रैन करें
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How to Face USFDA Audits GMP
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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
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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
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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
Your Queries:-
How to face USFDA Audit
How to face Audit
How to be in USFDA Compliance
How to prepare for audit
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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
Thanks a lot sir, very nice video❤
Very good
NICE VIDEO
👍
Important knowledge❤❤❤
Thank You Very Very Much Sir, you defined very well, it really helped me to understand the basics of Pharma HVAC system
Nice subjective presentation sir, thanks for your great efforts to educate Pharma world.
Very helpfull, Thank You.
Important and informative video
Too good
Nice video sir..
Very nicely explained
Kindly make video on area classification of clean room and explain each qualification test in sequence
Man gaye guru
Great knoweledge sir hope the same knoweledge we acquire in future
Please share to our other Pharma friends to spread Knowledge
Thank you sir your explanation was on point
Thanks A Lot Dear
Please also share to your friends groups
Nice
Thanks
Welcome
Very nice video Sir
Thanks a Lot
Please also share to your friends and groups
Hi
Sirji kindly give presentation on pharma artwork handling and guidelines associated with artwork
During autoclave validation how to use thermocouple give brief knowledge
Steam Sterilization; All You Want to Know #sterilization #aseptic #validation #sterile @PHARMAVEN
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How to decide the range of DP through magnehelic gauage
Sir pls explain how to select sample location in NVPC test of AHU
Acph ditel
Sir what isUp stream & down stream
Sir apne pre filter ke bad kon filter bole the clear bataiye ya screen pe likh diya kijiye
Recovery test we need do dynamics and statics explain sir
Static
Any specific guidelines on this, plz suggest..
Do we required any system or utility for cold and hot air circulation?
Chilled water/refrigeration and hot water circulation required to maintain temperature and relative humidity.
We don’t need to circulate hot and cold air
During filling ,NVPC count of last 35 min data needs to be check in ft cube? Or only excursion count only to be evaluated?
😢
During re qualifications what parameters to be test
Pre filter pote size sir and fine filter
Sir kite. Tye ke filetter hepha filete me hote hai
Sir, ACPH test required during initial OQ of AHU ?
How we assure that fresh air is 10% or not, it may be 7% or 8%
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.
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
Can you please make ఆ video on how to establish online నువపీసీ conters in filling room.
Can you mention English word for Telugu word?
@@PHARMAVEN Sorry didnt noticed, its online NVPC counters.
if any modifications of existing AHU.
Viable and non viable particle can I monitoring 1day only
No
Three days required
@@PHARMAVEN Respected sir please tell me reason why required three day
AHU modification calls for Requalification which is at least three days
What modification are you going to do?
We are plan to replace EC fan drive, all filters and diffuser
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.
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
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?
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.
Completely agree with answers 👍