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PharmGrow
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This channel is dedicated for guideline based technical information about our Pharmaceutical industry.
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For any enquiry : Yogpharma409@yahoo.com
Subscribe to channel to be a part of knowledge journey....
WhatsApp Channel : whatsapp.com/channel/0029VaBjiGE7j6fyUryjxZ3J
For any enquiry : Yogpharma409@yahoo.com
ICH Q10 Guideline l pharmaceutical quality system l ICH Q10 in pharmaceutical industry l Q&A
ICH Q10 Guideline l pharmaceutical quality system l ICH Q10 in pharmaceutical industry l Interview Question and answers
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Pick your favourite topic video from below playlist:
1. QMS - Quality Management System in Pharmaceutical industry : czcams.com/play/PLWElJz3ahCNqnXftgTHiLdxM154CmoRsR.html
2. QA- Quality assurance in Pharmaceutical industry. : czcams.com/play/PLWElJz3ahCNoFfgX3bYjXwSPtO8KyK1gP.html
3. QC - Quality Control in Pharmaceutical industry :
czcams.com/play/PLWElJz3ahCNpvL3dRLtGjc_BRuRkx0CVT.html
4. OSD - Tablet Manufacturing in Pharmaceutical industry :
czcams.com/play/PLWElJz3ahCNoSYaSlSrkdbk6j-bHTy72T.html
5. Injectable processing - Injectable processing or Sterile dosage formulation : czcams.com/play/PLWElJz3ahCNoqGqSfdeJlBgpKfuUlQF_f.html
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Questions covered:
Q. What is ICH Q10 Guideline and why it is important ?
Q. What is change management (i.e. change control) as per ICH Q10 ?
Q. What is QRM (i.e. Quality Risk Management) as per ICH Q10 ?
Q. What is Corrective action as per ICH Q10 ?
Q. What is Preventive action as per ICH Q10 ?
Q. What are three objectives of ICH Q10 ?
Q. What is state of control as per ICH Q10 ?
Q. What is Quality as per ICH Q10 ?
Q. What are the four important elements of Pharmaceutical Quality system elements as per ICH Q10 ?
Q. How should companies handle CAPA according to ICH Q10?
Q. What is Technology transfer as per ICH Q10 ?
Q. What ICH Q10 guides about Quality policy ?
Q. What change control management should include as per ICH Q10 ?
Q. Change management system shall be applicable at which stage of product ?
Q. What are the four stages of product life cycle ?
Q. What is management review and what it should include as per ICH Q10 ?
Q. How review of performance of pharmaceutical Quality system can be done as per ICH Q10 ?
Q. For what purpose Internal audits should be used in the pharmaceutical industry as per ICH Q10 ?
Q. What are the important internal and external factors impacting Pharmaceutical Quality system as per ICH Q10 ?
Q. What Innovation as per ICH Q10 ?
Q. What is senior management as per ICH Q10 ?
Q. What are performance indicators as per ICH Q10 ?
Q. What are the activities for continual improvement of the pharmaceutical quality system ?
Q. What is pharmaceutical quality system model as per ICH Q10 ?
Q. What is document history for ICH Q10 ?
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Keywords to find this video:
ich guidelines,ich guidelines pharmaceuticals,ich guideline q10 pharmaceutical quality system,ich guidelines in quality assurance,guideline,pharmaceutical guidelines,ich guidelines for validation,ich guideline q10,q1 guidelines,ich guidelines interview questions,gmp guidelines,ich q8 guidelines,ich guidelines list,ich guideline training,ich safety guidelines,ich guidelines basics,ich guidelines videos,what is ich guidelines,revised ich q9 guideline
-----------------------------------------------------------------------------------------------
Copyright disclaimer:
“Any illegal reproduction of this content will result in immediate legal action.”
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Pick your favourite topic video from below playlist:
1. QMS - Quality Management System in Pharmaceutical industry : czcams.com/play/PLWElJz3ahCNqnXftgTHiLdxM154CmoRsR.html
2. QA- Quality assurance in Pharmaceutical industry. : czcams.com/play/PLWElJz3ahCNoFfgX3bYjXwSPtO8KyK1gP.html
3. QC - Quality Control in Pharmaceutical industry :
czcams.com/play/PLWElJz3ahCNpvL3dRLtGjc_BRuRkx0CVT.html
4. OSD - Tablet Manufacturing in Pharmaceutical industry :
czcams.com/play/PLWElJz3ahCNoSYaSlSrkdbk6j-bHTy72T.html
5. Injectable processing - Injectable processing or Sterile dosage formulation : czcams.com/play/PLWElJz3ahCNoqGqSfdeJlBgpKfuUlQF_f.html
-----------------------------------------------------------------------------------------------
Questions covered:
Q. What is ICH Q10 Guideline and why it is important ?
Q. What is change management (i.e. change control) as per ICH Q10 ?
Q. What is QRM (i.e. Quality Risk Management) as per ICH Q10 ?
Q. What is Corrective action as per ICH Q10 ?
Q. What is Preventive action as per ICH Q10 ?
Q. What are three objectives of ICH Q10 ?
Q. What is state of control as per ICH Q10 ?
Q. What is Quality as per ICH Q10 ?
Q. What are the four important elements of Pharmaceutical Quality system elements as per ICH Q10 ?
Q. How should companies handle CAPA according to ICH Q10?
Q. What is Technology transfer as per ICH Q10 ?
Q. What ICH Q10 guides about Quality policy ?
Q. What change control management should include as per ICH Q10 ?
Q. Change management system shall be applicable at which stage of product ?
Q. What are the four stages of product life cycle ?
Q. What is management review and what it should include as per ICH Q10 ?
Q. How review of performance of pharmaceutical Quality system can be done as per ICH Q10 ?
Q. For what purpose Internal audits should be used in the pharmaceutical industry as per ICH Q10 ?
Q. What are the important internal and external factors impacting Pharmaceutical Quality system as per ICH Q10 ?
Q. What Innovation as per ICH Q10 ?
Q. What is senior management as per ICH Q10 ?
Q. What are performance indicators as per ICH Q10 ?
Q. What are the activities for continual improvement of the pharmaceutical quality system ?
Q. What is pharmaceutical quality system model as per ICH Q10 ?
Q. What is document history for ICH Q10 ?
-----------------------------------------------------------------------------------------------
Keywords to find this video:
ich guidelines,ich guidelines pharmaceuticals,ich guideline q10 pharmaceutical quality system,ich guidelines in quality assurance,guideline,pharmaceutical guidelines,ich guidelines for validation,ich guideline q10,q1 guidelines,ich guidelines interview questions,gmp guidelines,ich q8 guidelines,ich guidelines list,ich guideline training,ich safety guidelines,ich guidelines basics,ich guidelines videos,what is ich guidelines,revised ich q9 guideline
-----------------------------------------------------------------------------------------------
Copyright disclaimer:
“Any illegal reproduction of this content will result in immediate legal action.”
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Hi sir
Hii
Nice sir to gideanc ❤
Thanks 👍
Super brother
Thanks 👍
Sir i am D Pharma and b.pharma holder .. haridwar m qc m koi job mil skti h ky
If post vaccum phase is in running stage, during post vaccum phase gets low due to power interruption. Does it consider? Or Does it is under deviation? Cycle will be considered complete
It is deviation and cycle will be considered complete. Deviation has to be raised for root cause analysis and impact assessment likely drying of load.
@@PharmGrow thanks for your information
What is maximum length of silicone tube/ braided hose pipe in autoclave? As per FDA norms/ EN285 or other reference?
I need to check this. I will reply once i confirm
🎉
Cold sopt
plz make a single video for VHP cycle as well as BI cycle.
Ok. I will work on this 👍
Nice Information to all
Thanks 👍
What is the impact on pre and post loads if B& D test fails how you will assess it?
Ans : to ensure Cold spot sterilization. Kudo to your piece of work 🤌🏾👌🏿👏🏿👏🏿. #valuable information.
Thank you so much 👍
Nice work. Keep it up
Thanks 👍
Dear sir you make a very best video for interview, thanks 🙏🙏🙏🙏, please make next as relevant.
Thanks 👍
Very informative..thank you
Thank you 👍
Today is my interview let see what happens from this R and D department
Best luck dear 👍
@@PharmGrow IS THIS MUCH QUESTION IS ENOUGH FOR INTERVIEW
Clearing interview depends on many factors. You can refer to all those guidelines in last question. That will help you 👍
Are you an expert in the pharmaceuticals/healthcare/health/beauty industry? Do you hold prestigious certifications like CFS, FDA, CE, ISO...? Share your knowledge and experience with the professional community on StrongBody Medi Pro! The platform connects leading experts, helping you enhance your reputation and expand your business network.
Are you an expert in the pharmaceuticals/healthcare/health/beauty industry? Do you hold prestigious certifications like CFS, FDA, CE, ISO...? Share your knowledge and experience with the professional community on StrongBody Medi Pro! The platform connects leading experts, helping you enhance your reputation and expand your business network.
Good information video sir...tq
Thanks 👍
Link to download ICH Q7 Guideline : database.ich.org/sites/default/files/Q7%20Guideline.pdf
Good information 👍
Thank you 👍
Sir plz ppt send me
Drain temperature point cold to Condensate temprature to forward stream line n cool water
Wt is kelvin
The kelvin (abbreviation K), less commonly called the degree Kelvin (symbol, o K), is the Standard International ( SI ) unit of thermodynamic temperature.
Sir what is difference between processing area and quarantine area regarding qualifications
Processing area is area in which batch processing is carried out like Granulation, compression, coating, formulation, filling etc. in Quarantine area we keep processed or to be processed materials like in-process area, day stock area, cold rooms etc.
Useful
Thanks 👍
Very knowledgible video.Thank you🙏
Thanks
Difference between fish bone and ishikawa?
The diagram was popularized by Kaoru Ishikawa, a Japanese quality control expert, which is why it's also commonly known as an Ishikawa diagram. So, in short, there is no difference between a Fishbone diagram and an Ishikawa diagram - they're just two different names for the same tool!
Manufacturing department (User department)
Agree.
Hi sir MSAT has growth in pharma for future plz tell me sir
Abosoluly yes. MSAT has growth 👍
@@PharmGrow tq sir but is it available in all pharma companies
With the title as Technology transfer department same department exist in most of companies. In recent MSAT scope has increased.
@@PharmGrow tq sir I got R&D ,AR&D and MSAT offers so which is best I don't know that's why??
We cant say any one is best. But you can evaluate based on which company has sent you offer, types of product handled etc. I will personnaly prefer RnD. From RnD you can switch anywhere and RnD itself has wide scope.
Sir aap hindi me video baniye
Ok
Please hide subtitles
This is user specific setting. You can do it from your youtube.
Good 🎉
Thanks 👍
Hello .!!! I’m Dr Priyanka.. I’m interested in knowing more about this method as i’m doing some research over tablet.... would be grateful if you help please
Sure. You can contact me on 9623749708. My mail ID is yogpharma409@yahoo.com
Really good work 👏
Thanks 👍
Very good info, all the best
Thanks 👍
Thanks
Welcome 👍
Who are doing filter validation? R&D or vendor?
Ideally this is joint responsibility. User department, R&D and if required vendor should perform filter validation. In most of companies set-up required for filter validation is not available with R&D,so they prefer to get it done from Vendor.
Thank so much for your information! It is so good. If you have information about “requirements in filling room guidelines” plz share or guide to me where I could find information! Thanks
Thanks. I will work on it 👍
Which guidelines mentioned the PHT acceptance criteria.
PHT acceptance criteria may vary based on type of equipment. No specific guideline referred for PHT acceptance criteria.
Hydrophobic use for water and hydrophilic use for air and gas please correct it
Thanks for update 👍
Media fill required for nasal ?
Yes if you claiming it sterile.
Sir me dpharma kyon hon kuch job miliga production me
Yes. Definitely 👍
Apka contact number chahihe
Thank you so much 😊
Thanks for appreciation 👍
What is different between Standard sterilization and HPHV sterilization?
There is no as such concept of Standard cycle for autoclave. Can you please tell me what you call for, so i can answer.
What is difference between standard cycle and HPHV cycle?
There is no as such concept as standard cycle. Can you please explain for what you claim as standard cycle, so i can answer.
Very nice 😊
Thanks 👍
Nice
Thanks
usefull
Thanks for your comment 👍
Very nice , plz could you share membrane filteration sterility method and,coliform text, colony forming unit count , environmental monitoring viable non viable methods like microbiology related questionaire? It will be helpful
Sure. I will work on these topics
@@PharmGrow appreciated
Comductivity limit should be less than 1.3 microsemen
Yes. You are right. Thanks for update.