Industrial Pharmacy and Management BP-702T
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Questions and Answers

Technology transfer includes transfer of:

  • Documents
  • Knowledge
  • Experience
  • All of the above (correct)
  • Risk reduction is a part of:

  • Risk review
  • Risk control (correct)
  • Risk evaluation
  • Risk assessment
  • NCL is situated at:

  • Pune (correct)
  • Delhi
  • Chennai
  • Nagpur
  • What is technology and technology development?

    <p>Technology refers to the application of scientific knowledge for practical purposes. Technology development is the process of improving existing technologies or creating new technologies through research and innovation.</p> Signup and view all the answers

    What is quality risk management? Explain QRM process.

    <p>Quality risk management (QRM) is a systematic process for assessing, controlling, communicating, and reviewing risks to quality across the product lifecycle. The QRM process involves risk assessment, risk control, risk communication, and risk review.</p> Signup and view all the answers

    Draw the Organisation chart of CDSCO.

    <p>The Organisation chart of CDSCO includes various levels such as the Directorate General, Deputy Drug Controllers, and different divisions handling approvals, inspections, and policy.</p> Signup and view all the answers

    Explain the function, vision and mission of APCTT.

    <p>The function of APCTT (Asia-Pacific Centre for Technology Transfer) is to promote technology transfer and cooperation in the region. Its vision is to be a leading organization in technology transfer, and its mission is to support sustainable development through innovative technological solutions.</p> Signup and view all the answers

    Study Notes

    Industrial Pharmacy and Management Overview

    • B.Pharm. VII Semester includes a focus on Industrial Pharmacy and Management.
    • Exam format includes multiple choice questions (MCQs), short answers, and long answers.

    Part I - Multiple Choice Questions

    • Technology transfer encompasses the transfer of documents, knowledge, and experience, highlighting its comprehensive nature.
    • Risk reduction is a component of risk control, which is essential in managing potential adverse outcomes.
    • NCL (National Chemical Laboratory) is located in Pune, a key site for research and development in pharmaceuticals.

    Part II - Short Answers Overview

    • Technology Development: Refers to the process of converting scientific discoveries into practical applications, emphasizing innovation in pharmaceutical science.
    • Quality Risk Management (QRM): Involves systematic processes to assess, control, and communicate risks, ensuring the safety and efficacy of pharmaceutical products. It includes risk identification, risk analysis, and risk evaluation.
    • CDSCO Organisation Chart: Outlines the structure of the Central Drugs Standard Control Organization, including key roles and responsibilities in drug regulation.
    • APCTT (Asian and Pacific Centre for Transfer of Technology): Focuses on enhancing technological capacity in the Asia-Pacific region to promote sustainable development.
    • NRDC (National Research Development Corporation): Aims to promote, develop, and commercialize emerging technologies, bridging the gap between research institutions and industry.

    Part III - Long Answers Focus

    • Technology Transfer in Pharmaceuticals: Involves the sharing of technology between different entities to improve processes. Reasons include enhancing product quality, compliance with regulatory standards, and increased market access. Benefits consist of cost reductions, faster product development, and knowledge sharing.
    • Confidential Agreements and MoUs: Legal frameworks that govern the transfer of technology, outlining the obligations of parties involved, protection of intellectual property, and terms of collaboration.
    • Drug Regulatory Authorities in India: Central and State authorities oversee the regulation of drugs, ensuring safety, quality, and efficacy. Functions include drug approval processes, quality assurance, and monitoring compliance with regulations.

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    Description

    Test your knowledge in Industrial Pharmacy with this quiz covering key concepts and risk management principles. Designed for B.Pharm students in their seventh semester, this session will challenge your understanding and application of the subject matter. Prepare for exam success with practice questions across various topics!

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