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Deviations in Pharmaceutical industry l Interview Questions 

PharmGrow
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Here are the selected top 26 interview questions about deviations in pharmaceutical industry
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Pick your favourite topic video from below playlist:
1. QMS - Quality Management System in Pharmaceutical industry : • QMS - Quality Manageme...
2. QA- Quality assurance in Pharmaceutical industry. : • QA- Quality assurance ...
3. QC - Quality Control in Pharmaceutical industry : • QC - Quality Control i...
4. OSD - Tablet Manufacturing in Pharmaceutical industry : • OSD - Tablet Manufactu...
5. Injectable processing - Injectable processing or Sterile dosage formulation : • Injectable processing ...
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Questions covered:
Q.1 :What is Deviation?
Q.2: Why we should raise deviation?
Q.3: What is difference between incident and deviation?
Q.4: What are the categories / classifications of deviation?
Q.5: How do you classify deviations?
Q.6: What is thumb rule for writing deviation description?
Q.7: Planned deviations shall be raised or not ?
Q.8: What is CFT and role of CFT in deviation investigation ?
Q.9: What are the three stages / Levels of deviation?
Q.10: Which investigation tools are used during deviation investigation ?
Q.11: How do you select investigation tool ?
Q.12: How do you perform deviation impact assessment ?
Q.13: Why review of previous deviations is done during investigation ?
Q.14: Why we should raise deviation within 24 hours of identification?
Q.15: What should be the deviation closure timeline for minor, major and critical deviations?
Q.16: What are the trigger points for deviation?
Q.17: Which guideline most commonly referred for deviation handling ?
Q.18: Which are the basic components of deviation investigation template ?
Q.19: Why deviation count is important in QMS ?
Q.20: Which Software / application is most commonly used for deviation handling?
Q.21: Can we close deviation without getting root cause ?
Q.22: Can we re-open closed deviation ?
Q.23: Whether we should raise deviation for OOS / OOT results ?
Q.24: Can we cancel close raised deviation ?
Q.25: Can we cover / address multiple discrepancies in single deviation ?
Q.26: What are the most common root causes for deviations?
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Key words:
deviations in pharmaceutical industry,data integrity in pharmaceutical industry,pharmaceutical industry, capa in pharmaceutical industry,change control in pharmaceutical industry,deviation classification,pharmaceutical,environmental controls,mechanical failure,sampling of incoming materials,deviations,industry,deviation,quality management system,process control parameters,line clearance,critical deviation,how to handle,mixed lots on pallets,examples of deviation
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7 авг 2024

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Комментарии : 29   
@Vikashverma27980
@Vikashverma27980 Год назад
bro can you make the video of difference between sterilization and sentization..plz..
@PharmGrow
@PharmGrow Год назад
Sure. I will do it 👍
@sanchalaldeshmukh2673
@sanchalaldeshmukh2673 Год назад
Kindly request to send sir please give information on ampule and vial filling machine validation or qualification
@PharmGrow
@PharmGrow Год назад
Ok
@gajanankulkarni2527
@gajanankulkarni2527 Год назад
Great efforts ,Because of your channel my knowledge is increasing I have one question about deviation is that which type of deviation required investigation for major or critical thanks in advance
@PharmGrow
@PharmGrow Год назад
Thanks for comment 👍 Ideally we should investigate all type of deviations. Deviation investigation should be compulsory for all category like minor, major and critical for following reasons, 1. To perform impact assesemt of batches executed and batches to be executed. 2. To identify root cause and make necessory corrective and preventive actions to avoid repeat occurence. 3. To track and monitor QMS control over manufacturing and analytical processes.
@yadagiripalina1219
@yadagiripalina1219 Год назад
Bro can you make the vedio of NVPC
@PharmGrow
@PharmGrow Год назад
Thanks for suggestion. I started working on NVPV
@sreedhar0404
@sreedhar0404 3 месяца назад
Nice
@PharmGrow
@PharmGrow 3 месяца назад
Thanks
@jayanalini5069
@jayanalini5069 Год назад
Hi sir...can u please give pdf copies of topics..it will be helpful for me
@PharmGrow
@PharmGrow Год назад
You can download video
@shubhamdogra4831
@shubhamdogra4831 Год назад
Sir mfg tank sip validation ka video bnao plz
@PharmGrow
@PharmGrow Год назад
Ok 👍
@hanumahari9679
@hanumahari9679 Год назад
Sir if you don't mind will you pls explain in Telugu language also
@PharmGrow
@PharmGrow Год назад
Ok. I will try to do.
@krish_krish354
@krish_krish354 26 дней назад
Difference between fish bone and ishikawa?
@PharmGrow
@PharmGrow 26 дней назад
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!
@shodhaharshad3043
@shodhaharshad3043 Год назад
Sir please give this question pdf
@PharmGrow
@PharmGrow Год назад
Please Comment your mail ID or contact no.
@user-nt1ft8jh4i
@user-nt1ft8jh4i День назад
Can u plz send me the question PDF
@PharmGrow
@PharmGrow День назад
Mail me on Yogpharma409@yahoo.com
@swethav.p3851
@swethav.p3851 Год назад
Can u provide the reference for this ppt
@PharmGrow
@PharmGrow Год назад
There are multiple documents referred. Please tell me point for which reference required.
@swethav.p3851
@swethav.p3851 Год назад
@@PharmGrow thanks for the reply. Wil it be possible to give ref for all documents
@PharmGrow
@PharmGrow Год назад
I need time to work on this. I will definitely reply here.
@swethav.p3851
@swethav.p3851 Год назад
Thanks a lot..
@PharmGrow
@PharmGrow Год назад
Hello Mam, Below three guidelines were referred while creating the presentation, 1. Deviation Basic concepts: ICH Q10: 2008 2. Deviation classification: WHO Guideline on Quality Risk Management Annex 2 3. Question related to OOS investigation: Guidance for industry for investigating OOS test results for pharmaceutical production (October 2006) Additionally, few points were included based on the cumulative review of few USFDA’s audit observations shared on official site and followed established industrial deviation handing practices.
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