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Pharmaceutical Quality Assurance Quiz 1

Pharmaceutical quality assurance plays a vital role in ensuring the safety and effectiveness of medications. It is an essential component of the pharmaceutical industry that involves a systematic approach to prevent errors, defects, and deviations in drug manufacturing. This article will explore the world of pharmaceutical quality assurance, its significance, and an informative quiz to test your knowledge in this field.

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1. A company including its manager has 50 members. TQM philosophy is followed by 40 members only. Did the company properly implement TQM?

a. Yes, only 25 members were sufficient for TQM implementation

b. Yes, only 14 members were sufficient for TQM implementation

c. We cannot comment on TQM implementation

d. No, TQM implementation requires the participation of all members of the company

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2. Arrange the steps of QA in ascending order?

a. Customer needs, design development, material control, process control, finished product

b. Material control, process control, customer need, design development, finished product

c. Material control, servicing, process control, material control, design development

d. Customer needs, material control, design development, process control, marketing

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3. The lack of proper training to the employees can act as a barrier to TQM implementation

a. False

b. True

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4. - P-D-C-A stands for-

a. Process- Do- Chek- Act

b. Plan- Do- Correct- Act

c. Process- Do- Correct- Act

d. Plan- Do- Check- Act

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5. What is the first step of QA?

a. Development of standards

b. Identification of customer need

c. Material control

d. Servicing

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6. According to Deming’s Quality Chain Reaction, quality improvement results in decreased productivity.

a. False

b. True

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7. The role of management is to-

a. Define EMS

b. Monitor the Effectiveness

c. All

d. Provide Resources

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8. Match the following:

a. A-3, B-4, C-2, D-1

b. A-1, B-3, C-4, D-2

c. A-2, B-3, C-1, D-4

d. A-4, B-1, C-3, D-2

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9. Validation is an example of

a. Calibration

b. Quality Assurance

c. Quality Control

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10. Quality is conformance to requirements. Identify the quality guru who said this.

a. Ishikawa

b. Crosby

c. Ohno

d. Deming

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11. What is ISO?

a. None

b. International Organization for Standard

c. Indian Organization for Standard

d. Internal Organization for Standard

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12. ICH stands for?

a. Indian Council for harmonization

b. Indian Conference for harmonization

c. International Conference for harmonization

d. International Council for Harmonization

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13. How can quality be quantified? (Q=Quality, P=Performance, E=Expectations)

a. Q=P/E

b. Q=P+E

c. Q=P-E

d. Q=P*E

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14. Quality is fitness for use. Identify the quality guru who said this.

a. Deming

b. Crosby

c. Taguchi

d. Juran

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15. EMS stands for-

a. Engineering management system

b. Equipment management system

c. Environmental management system

d. Employee management system

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16. The objective of ISO-9000 family of quality management is-

a. Customer satisfaction

b. Employee satisfaction

c. Environmental issues

d. Skill enhancement

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17. GMP are directed primarily at

a. Ensuring that all products are made in accordance with the formula.

b. Ensuring that all products are tested according to specifications.

c. Preventing cross-contamination only

d. Minimizing risks in production that can not be prevented through testing of finished products

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18. What is QA?

a. It is the measurement of degree to which a product satisfies the need

b. Any systematic process used to ensure quality in the process

c. Process of identifying defects

d. It is a corrective tool

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19. What is TQM?

a. Total Quality Maintenance

b. Total Quality Management

c. Total Quality Managers

d. Total Quality Mitigation

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20. Which of the following option is correct regarding QA and QC?

a. QA and QC are independent to each other

b. QC may or may not depend on QA

c. QA is an integral part of QC

d. QC is an integral part of QA

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21. ISO 14001 gives stress on-

a. Environmental Protection

b. Prevention rather than detection

c. All

d. Plan-Do-Check-Act

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22. Which of the following is for Environment Management?

a. ISO-9000

b. ISO-14000

c. ISO-31000

d. ISO-26000

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23. Total Quality Management focuses on-

a. None

b. Customer and Employee

c. Customer

d. Employee

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24. Which ‘pillar of TQM’ is referred to when the study of customer needs is done.

a. Employee Empowerment

b. Process Management

c. Customer Focus

d. Continuous Improvement

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25. The guidelines that describe the stability testing of drug substances and drug products are?

a. ICH Q1

b. ICH Q8

c. ICH Q9

d. ICH Q2

Your score is

The average score is 53%

Pharmaceutical Quality Assurance Quiz FAQs

1. Is pharmaceutical quality assurance mandatory for all drug manufacturers?

Yes, pharmaceutical quality assurance is mandatory for all drug manufacturers to ensure patient safety and regulatory compliance.

2. What are the consequences of not following GMP in drug manufacturing?

Failure to follow GMP can lead to product recalls, fines, and even the shutdown of manufacturing facilities.

3. How can I prepare for the pharmaceutical quality assurance quiz?

You can prepare for the quiz by reviewing the information in this article and exploring additional resources on the subject.

4. Are regulatory authorities the same worldwide?

No, different countries have their own regulatory authorities, such as the FDA in the United States and the EMA in Europe.

5. Why is continuous learning important in pharmaceutical quality assurance?

Continuous learning is essential to stay updated with industry changes and evolving regulations, ensuring the highest level of product quality and safety.

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