Pharmaceutical Quality Assurance MCQ With Answers

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Pharmaceutical Quality Assurance MCQ With Answers - Quiz

If you're looking for a fresh set of pharmaceutical quality assurance MCQs with answers, you should try out this quiz. It consists of some basic questions related to the pharmaceutical quality assurance department. This quality assurance aims to ensure whether the medication being provided to the patient is meeting the quality standards or not. So, do you think you can obtain full marks on this test? Let's check it out, and for that, you need to play this quiz. Good luck!


Questions and Answers
  • 1. 

    What does QA and QC stand for?

    • A.

      Quality Assurance and Queuing Control 

    • B.

      Quality Adjustment and Quality completion

    • C.

      Quality Assurance and Quality control 

    • D.

      Quality Adjustment and Queuing control

    Correct Answer
    C. Quality Assurance and Quality control 
    Explanation
    QA stands for Quality Assurance and QC stands for Quality Control. Quality Assurance refers to the systematic process of ensuring that a product or service meets specified requirements and standards. It involves the development and implementation of processes and procedures to prevent defects and errors. Quality Control, on the other hand, is the process of inspecting, testing, and evaluating a product or service to ensure that it meets the desired quality standards. It involves monitoring and measuring the quality of outputs and taking corrective actions when necessary.

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  • 2. 

    The objective of ISO-9000 family of Quality management is

    • A.

      Customer satisfaction

    • B.

      Employee satisfaction

    • C.

      Skill enhancement

    • D.

      Environmental issues

    Correct Answer
    A. Customer satisfaction
    Explanation
    The objective of the ISO-9000 family of Quality management is to ensure customer satisfaction. This means that the standards and guidelines set by ISO-9000 aim to help organizations meet customer expectations and deliver products or services that meet their needs and requirements. By implementing a quality management system based on ISO-9000, organizations can improve their processes, enhance customer satisfaction, and ultimately increase their competitiveness in the market.

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  • 3. 

    P-D-C-A stands for

    • A.

      Plan-Do-check-Act 

    • B.

      Plan-Do-correct-Act

    • C.

      Proceed-Do-check-Act 

    • D.

      Proceed-Do-correct-Act

    Correct Answer
    A. Plan-Do-check-Act 
    Explanation
    P-D-C-A stands for Plan-Do-Check-Act. This is a four-step management method used for continuous improvement in various processes. It involves planning the desired outcome, implementing the plan, checking the results against the objectives, and taking necessary corrective actions to improve the process. This cycle is repeated to ensure ongoing improvement and efficiency in organizations.

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  • 4. 

    The term validation in calibration is used for

    • A.

      Equipment 

    • B.

      Processes

    • C.

      None of these

    • D.

      All of these

    Correct Answer
    B. Processes
    Explanation
    Validation in calibration refers to the process of ensuring that a particular process or equipment meets the specified requirements and standards. It involves verifying and documenting that the measurements or results obtained from the process or equipment are accurate and reliable. Therefore, the correct answer is "Processes" as validation is primarily associated with validating the accuracy and reliability of processes rather than equipment.

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  • 5. 

    Physical dimension of equipment and accessories- comes under which qualification?

    • A.

      Design qualification (DQ)

    • B.

      Installation qualification (IQ)

    • C.

      Operational qualification

    • D.

      Performance qualification (PQ)

    Correct Answer
    A. Design qualification (DQ)
    Explanation
    The physical dimension of equipment and accessories is a characteristic that is assessed during the design qualification (DQ) process. DQ involves evaluating and verifying that the design of the equipment and accessories meet the specified requirements and standards. This includes assessing factors such as dimensions, materials used, and overall design features. Installation qualification (IQ) focuses on verifying that the equipment is installed correctly, operational qualification (OQ) ensures that the equipment operates within specified parameters, and performance qualification (PQ) tests the equipment's performance under normal operating conditions. However, none of these qualifications specifically address the physical dimension of equipment and accessories, making DQ the correct answer.

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  • 6. 

    The filling of products for terminal sterilization should generally be done in at least which environment?

    • A.

      Grade A

    • B.

      Grade B

    • C.

      Grade C 

    • D.

      Grade D

    Correct Answer
    C. Grade C 
    Explanation
    The correct answer is Grade C. Grade C is the appropriate environment for filling products for terminal sterilization. This grade provides a controlled and clean area with limited microbial contamination. It ensures that the products are protected from contamination during the filling process, reducing the risk of any potential microbial growth. Grades A and B are typically used for more critical operations, while Grade D is a less controlled environment.

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  • 7. 

    Low pressure inside the airlock and high pressure on both outer sides is called

    • A.

      Cascade airlock

    • B.

      Sink airlock

    • C.

      Bubble airlock

    • D.

      None of these

    Correct Answer
    B. Sink airlock
    Explanation
    A sink airlock refers to a situation where there is low pressure inside the airlock and high pressure on both outer sides. This creates a pressure differential that causes air or fluid to flow from the high-pressure areas to the low-pressure area, similar to how water flows down a sink drain. This term is commonly used in the context of fluid dynamics and can occur in various systems, such as pipelines or ventilation systems.

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  • 8. 

    Which of the following is not a QC test of for parenteral containers?

    • A.

      Sterility Test

    • B.

      Clarity Test

    • C.

      Pyrogen Test

    • D.

      Leakage Test

    Correct Answer
    D. Leakage Test
    Explanation
    The leakage test is not a QC test for parenteral containers because it is not specifically related to the quality control of the containers themselves. The purpose of a leakage test is to ensure that the container is properly sealed and does not leak any contents. While this is an important test for ensuring the integrity of the product, it is not directly related to the quality of the container itself. The other tests mentioned, such as the sterility test, clarity test, and pyrogen test, are all specifically designed to assess the quality and safety of the parenteral containers.

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  • 9. 

    Which of the following is for Environment management?

    • A.

      ISO-9000

    • B.

      ISO-14000

    • C.

      ISO-31000

    • D.

      ISO-21000

    Correct Answer
    B. ISO-14000
    Explanation
    ISO-14000 is the correct answer because it is a set of international standards that provide guidelines for organizations to establish and maintain an effective environmental management system. These standards help organizations identify and control their environmental impact, comply with regulations, and continually improve their environmental performance. ISO-14000 covers various aspects of environmental management, including environmental policy, planning, implementation, operation, performance evaluation, and corrective actions. It is designed to help organizations minimize their negative impact on the environment and promote sustainable practices.

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  • 10. 

    Which guideline stands for evaluation of stability data?

    • A.

      Q1B

    • B.

      Q1D

    • C.

      Q1E

    • D.

      Q1C

    Correct Answer
    C. Q1E
    Explanation
    Q1E stands for the guideline on Evaluation of Stability Data. This guideline provides recommendations on the evaluation of stability data for pharmaceutical products. It outlines the principles and procedures for conducting stability studies and determining the shelf life of drugs. The guideline helps ensure that pharmaceutical products remain safe and effective throughout their shelf life.

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