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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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Get ready to test your knowledge in the field of Pharmaceutical Quality Assurance. Please click on the right option to answer the questions. Good luck!

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1 / 25

1. EMS stands for-

a. Environmental management system

b. Equipment management system

c. Employee management system

d. Engineering management system

2 / 25

2. 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

3 / 25

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

a. False

b. True

4 / 25

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

a. Ishikawa

b. Ohno

c. Deming

d. Crosby

5 / 25

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

a. Plan- Do- Check- Act

b. Process- Do- Correct- Act

c. Plan- Do- Correct- Act

d. Process- Do- Chek- Act

6 / 25

6. Validation is an example of

a. Quality Assurance

b. Quality Control

c. Calibration

7 / 25

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

a. False

b. True

8 / 25

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

a. Skill enhancement

b. Environmental issues

c. Customer satisfaction

d. Employee satisfaction

9 / 25

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

a. QC is an integral part of QA

b. QA and QC are independent to each other

c. QA is an integral part of QC

d. QC may or may not depend on QA

10 / 25

10. What is TQM?

a. Total Quality Maintenance

b. Total Quality Management

c. Total Quality Mitigation

d. Total Quality Managers

11 / 25

11. Match the following:

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

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

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

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

12 / 25

12. ICH stands for?

a. International Council for Harmonization

b. Indian Council for harmonization

c. Indian Conference for harmonization

d. International Conference for harmonization

13 / 25

13. What is ISO?

a. Internal Organization for Standard

b. Indian Organization for Standard

c. None

d. International Organization for Standard

14 / 25

14. What is QA?

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

b. It is a corrective tool

c. Process of identifying defects

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

15 / 25

15. Total Quality Management focuses on-

a. None

b. Customer and Employee

c. Customer

d. Employee

16 / 25

16. The role of management is to-

a. Monitor the Effectiveness

b. All

c. Provide Resources

d. Define EMS

17 / 25

17. 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. We cannot comment on TQM implementation

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

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

18 / 25

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

a. Continuous Improvement

b. Customer Focus

c. Process Management

d. Employee Empowerment

19 / 25

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

a. Deming

b. Taguchi

c. Crosby

d. Juran

20 / 25

20. ISO 14001 gives stress on-

a. Prevention rather than detection

b. Plan-Do-Check-Act

c. Environmental Protection

d. All

21 / 25

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

a. ICH Q8

b. ICH Q1

c. ICH Q9

d. ICH Q2

22 / 25

22. What is the first step of QA?

a. Development of standards

b. Material control

c. Identification of customer need

d. Servicing

23 / 25

23. Which of the following is for Environment Management?

a. ISO-26000

b. ISO-9000

c. ISO-31000

d. ISO-14000

24 / 25

24. GMP are directed primarily at

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

b. Preventing cross-contamination only

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

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

25 / 25

25. Arrange the steps of QA in ascending order?

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

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

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

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

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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