ICH Q10 Guideline l pharmaceutical quality system l ICH Q10 in pharmaceutical industry l Q&A

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  • čas přidán 8. 09. 2024
  • ICH Q10 Guideline l pharmaceutical quality system l ICH Q10 in pharmaceutical industry l Interview Question and answers
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    Link to download ICH Q10 Guideline : database.ich.o...
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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. 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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