Corrective and Preventive actions in Pharmaceutical industry l Interview Questions

Corrective and Preventive actions in Pharmaceutical industry l Interview Questions
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Go to below playlists and search for a topic you want:
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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Q.1 :Why CAPA is considered as important in pharmaceutical industry ?
Q.2: Which guidelines are referred for CAPA in pharmaceutical industry ?
Q.3 : Against which QMS documents we can generate CAPA ?
Q.4 : What is difference between Corrective action and preventive action?
Q.5 : What is correction and how it is different than CAPA ?
Q.6 : What is CAPA effective check?
Q.7 : What is SMART approach for CAPA effectiveness check ?
Q.8 : Whether CAPA is mandatory for all investigations?
Q.9 : What should be the closure timeline for CAPA ?
Q.10 : Whether we need to raise change control for implementation of actions proposed in CAPA ?
Q.11 :Can we close CAPA by giving reference of change control to track same action ?
Q.12 :Can we close CAPA after that particular product is discontinued?
Q.13 :What should be the action plan in case of CAPA effectiveness check failure?
Q.14 :What should be checked during trending of CAPA?
Q.15 :Which important information shall be provided for extending CAPA timeline ?
Q.16 : What are the phases after identification of CAPA ?
Q.17 : What Global CAPA ?
Q.18 : What is standalone CAPA ?
Q.19 : What is role of CAPA Co-ordinator?
Q.20 : How immediate actions differ than CAPA ?
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[@mahipalreddykashireddy7944]

Thanks for the info Mr.Grow.

[@loveloveonly8777]

Very useful for that please same like that APQR preparation also want video

[@PharmGrow]

Will upload soon 👍

[@irfankakar41]

Very useful guidlines

[@PharmGrow]

Thanks

[@RAMKUMAR-fb7gt]

Thank for sharing

[@PharmGrow]

Thanks

[@vishalholkar]

The schematic for corrective action seems incorrect. Corrective action does not prevent from reoccurrence. Please rectify the same.

[@PharmGrow]

Dear vishal, coorective action are taken to prevent reoccurence. Given schematic is correct.

[@vishalholkar]

Corrective action is the action taken to correct the problem. It is not a confirmation that this action will help prevent reoccurrence of problem. Once a corrective action is taken, it is also supplemented by a preventive action. eg. if a machine breakdown, the corrective action is to call a technician and repair it. Preventive action for the same machine is to make preventive maintenance schedule. If such preventive action is not taken, the problem may occur again even though you took the corrective action by calling the person to repair it initially. Hope my point is clear now.

[@PharmGrow]

I understood what you want to say. Can you provide any guideline / document support for view you stated.