Deviations in Pharmaceutical industry l Interview Questions

Here are the selected top 26 interview questions about deviations in pharmaceutical industry
-----------------------------------------------------------------------------------------------------------------------------------------------
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 ...
-----------------------------------------------------------------------------------------------------------------------------------------------
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?
-----------------------------------------------------------------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------------------------------------------------------------
Copyright disclaimer: “Any illegal reproduction of this content will result in immediate legal action.”

[@sreedhar0404]

Nice

[@PharmGrow]

Thanks

[@gajanankulkarni2527]

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]

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 roit cause and make necessory corrective and preventive actions to avoid repeat occurence.
3. To track and monitor QMS control over manufacturing and analytical processes.

[@Vikashverma27980]

bro can you make the video of difference between sterilization and sentization..plz..

[@PharmGrow]

Sure. I will do it 👍

[@sanchalaldeshmukh2673]

Kindly request to send sir please give information on ampule and vial filling machine validation or qualification

[@PharmGrow]

Ok

[@yadagiripalina1219]

Bro can you make the vedio of NVPC

[@PharmGrow]

Thanks for suggestion. I started working on NVPV

[@hanumahari9679]

Sir if you don't mind will you pls explain in Telugu language also

[@PharmGrow]

Ok. I will try to do.

[@shubhamdogra4831]

Sir mfg tank sip validation ka video bnao plz

[@PharmGrow]

Ok 👍

[@jayanalini5069]

Hi sir...can u please give pdf copies of topics..it will be helpful for me

[@PharmGrow]

You can download video

[@shodhaharshad3043]

Sir please give this question pdf

[@PharmGrow]

Please Comment your mail ID or contact no.

[@swethav.p3851]

Can u provide the reference for this ppt

[@PharmGrow]

There are multiple documents referred. Please tell me point for which reference required.

[@swethav.p3851]

@@PharmGrow thanks for the reply. Wil it be possible to give ref for all documents

[@PharmGrow]

I need time to work on this. I will definitely reply here.

[@swethav.p3851]

Thanks a lot..

[@PharmGrow]

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.