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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
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Copyright disclaimer:
“Any illegal reproduction of this content will result in immediate legal action.”
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Komentáře

  • @nagraj456
    @nagraj456 Před dnem

    Hi sir

  • @desivlogs1164
    @desivlogs1164 Před 2 dny

    Nice sir to gideanc ❤

  • @pachipalamallikarjunarao512

    Super brother

  • @kajal1851
    @kajal1851 Před 4 dny

    Sir i am D Pharma and b.pharma holder .. haridwar m qc m koi job mil skti h ky

  • @RakeshKumar-sx8zm
    @RakeshKumar-sx8zm Před 4 dny

    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

    • @PharmGrow
      @PharmGrow Před 4 dny

      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.

    • @RakeshKumar-sx8zm
      @RakeshKumar-sx8zm Před 4 dny

      @@PharmGrow thanks for your information

    • @RakeshKumar-sx8zm
      @RakeshKumar-sx8zm Před 4 dny

      What is maximum length of silicone tube/ braided hose pipe in autoclave? As per FDA norms/ EN285 or other reference?

    • @PharmGrow
      @PharmGrow Před 4 dny

      I need to check this. I will reply once i confirm

  • @koppisettiajay1308
    @koppisettiajay1308 Před 5 dny

    🎉

  • @jamalpurnareshjamalpurpark3532

    Cold sopt

  • @divakarsree
    @divakarsree Před 8 dny

    plz make a single video for VHP cycle as well as BI cycle.

    • @PharmGrow
      @PharmGrow Před 8 dny

      Ok. I will work on this 👍

  • @adityasaik7854
    @adityasaik7854 Před 9 dny

    Nice Information to all

  • @Manicstreams
    @Manicstreams Před 10 dny

    What is the impact on pre and post loads if B& D test fails how you will assess it?

  • @sanapathisekhar9780
    @sanapathisekhar9780 Před 10 dny

    Ans : to ensure Cold spot sterilization. Kudo to your piece of work 🤌🏾👌🏿👏🏿👏🏿. #valuable information.

  • @learningwithchampshivansh3964

    Nice work. Keep it up

  • @cabinedu9792
    @cabinedu9792 Před 15 dny

    Dear sir you make a very best video for interview, thanks 🙏🙏🙏🙏, please make next as relevant.

  • @anshikabhardwaj3917
    @anshikabhardwaj3917 Před 18 dny

    Very informative..thank you

  • @lokesh6265
    @lokesh6265 Před 18 dny

    Today is my interview let see what happens from this R and D department

    • @PharmGrow
      @PharmGrow Před 18 dny

      Best luck dear 👍

    • @lokesh6265
      @lokesh6265 Před 18 dny

      @@PharmGrow IS THIS MUCH QUESTION IS ENOUGH FOR INTERVIEW

    • @PharmGrow
      @PharmGrow Před 18 dny

      Clearing interview depends on many factors. You can refer to all those guidelines in last question. That will help you 👍

  • @Kylie.StrongBodySupplier

    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.

  • @Kylie.StrongBodySupplier

    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.

  • @chaithuchilledits3047

    Good information video sir...tq

  • @PharmGrow
    @PharmGrow Před 18 dny

    Link to download ICH Q7 Guideline : database.ich.org/sites/default/files/Q7%20Guideline.pdf

  • @muralikrishnapatchineela3508

    Good information 👍

  • @NeerajSingh-ft2cb
    @NeerajSingh-ft2cb Před 19 dny

    Sir plz ppt send me

  • @pulavarthijanakiram9701

    Drain temperature point cold to Condensate temprature to forward stream line n cool water

  • @pulavarthijanakiram9701

    Wt is kelvin

    • @PharmGrow
      @PharmGrow Před 19 dny

      The kelvin (abbreviation K), less commonly called the degree Kelvin (symbol, o K), is the Standard International ( SI ) unit of thermodynamic temperature.

  • @Chikuonline
    @Chikuonline Před 22 dny

    Sir what is difference between processing area and quarantine area regarding qualifications

    • @PharmGrow
      @PharmGrow Před 19 dny

      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.

  • @RAMKUMAR-fb7gt
    @RAMKUMAR-fb7gt Před 24 dny

    Useful

  • @pranitasarode2775
    @pranitasarode2775 Před 24 dny

    Very knowledgible video.Thank you🙏

  • @krish_krish354
    @krish_krish354 Před 25 dny

    Difference between fish bone and ishikawa?

    • @PharmGrow
      @PharmGrow Před 25 dny

      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!

  • @koppisettiajay1308
    @koppisettiajay1308 Před 26 dny

    Manufacturing department (User department)

  • @nagalaganesh6509
    @nagalaganesh6509 Před 26 dny

    Hi sir MSAT has growth in pharma for future plz tell me sir

    • @PharmGrow
      @PharmGrow Před 26 dny

      Abosoluly yes. MSAT has growth 👍

    • @nagalaganesh6509
      @nagalaganesh6509 Před 26 dny

      @@PharmGrow tq sir but is it available in all pharma companies

    • @PharmGrow
      @PharmGrow Před 26 dny

      With the title as Technology transfer department same department exist in most of companies. In recent MSAT scope has increased.

    • @nagalaganesh6509
      @nagalaganesh6509 Před 26 dny

      @@PharmGrow tq sir I got R&D ,AR&D and MSAT offers so which is best I don't know that's why??

    • @PharmGrow
      @PharmGrow Před 26 dny

      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.

  • @upneshkumar5769
    @upneshkumar5769 Před 27 dny

    Sir aap hindi me video baniye

  • @kailaskale4333
    @kailaskale4333 Před 27 dny

    Please hide subtitles

    • @PharmGrow
      @PharmGrow Před 27 dny

      This is user specific setting. You can do it from your youtube.

  • @manojjmore5034
    @manojjmore5034 Před 27 dny

    Good 🎉

  • @priyankakundu875
    @priyankakundu875 Před 28 dny

    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

    • @PharmGrow
      @PharmGrow Před 28 dny

      Sure. You can contact me on 9623749708. My mail ID is yogpharma409@yahoo.com

  • @apoorvjain4209
    @apoorvjain4209 Před měsícem

    Really good work 👏

  • @VishnuYadav-fy5ok
    @VishnuYadav-fy5ok Před měsícem

    Very good info, all the best

  • @vandanagiri4007
    @vandanagiri4007 Před měsícem

    Thanks

  • @kailaskale4333
    @kailaskale4333 Před měsícem

    Who are doing filter validation? R&D or vendor?

    • @PharmGrow
      @PharmGrow Před 19 dny

      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.

  • @dongtruong2388
    @dongtruong2388 Před měsícem

    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

    • @PharmGrow
      @PharmGrow Před měsícem

      Thanks. I will work on it 👍

  • @sunilshewalkar
    @sunilshewalkar Před měsícem

    Which guidelines mentioned the PHT acceptance criteria.

    • @PharmGrow
      @PharmGrow Před 19 dny

      PHT acceptance criteria may vary based on type of equipment. No specific guideline referred for PHT acceptance criteria.

  • @shaileshranotkar20
    @shaileshranotkar20 Před měsícem

    Hydrophobic use for water and hydrophilic use for air and gas please correct it

  • @kailaskale4333
    @kailaskale4333 Před měsícem

    Media fill required for nasal ?

    • @PharmGrow
      @PharmGrow Před měsícem

      Yes if you claiming it sterile.

  • @sidhantsahoo9654
    @sidhantsahoo9654 Před měsícem

    Sir me dpharma kyon hon kuch job miliga production me

  • @BhavdipAKorat
    @BhavdipAKorat Před měsícem

    Thank you so much 😊

    • @PharmGrow
      @PharmGrow Před měsícem

      Thanks for appreciation 👍

  • @Kumar-sb3kd
    @Kumar-sb3kd Před měsícem

    What is different between Standard sterilization and HPHV sterilization?

    • @PharmGrow
      @PharmGrow Před měsícem

      There is no as such concept of Standard cycle for autoclave. Can you please tell me what you call for, so i can answer.

  • @Kumar-sb3kd
    @Kumar-sb3kd Před měsícem

    What is difference between standard cycle and HPHV cycle?

    • @PharmGrow
      @PharmGrow Před měsícem

      There is no as such concept as standard cycle. Can you please explain for what you claim as standard cycle, so i can answer.

  • @gunjanpatel10
    @gunjanpatel10 Před měsícem

    Very nice 😊

  • @yuvarajmachak4724
    @yuvarajmachak4724 Před měsícem

    Nice

  • @vikasloytla4589
    @vikasloytla4589 Před měsícem

    usefull

    • @PharmGrow
      @PharmGrow Před měsícem

      Thanks for your comment 👍

  • @binalgajjar2781
    @binalgajjar2781 Před měsícem

    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

  • @manojpanchal2737
    @manojpanchal2737 Před měsícem

    Comductivity limit should be less than 1.3 microsemen

    • @PharmGrow
      @PharmGrow Před měsícem

      Yes. You are right. Thanks for update.