QUALITY CONTROL

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Pre-Assessment Quiz

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13

Quality Control Pre-Assessment Quiz

Time: 60 minutes

Questions: 55

 

The number of attempts remaining is 1

 

 

1 / 55

What was one of the practical applications of Statistical Process Control (SPC) discussed in the content?

2 / 55

What is the primary focus of Lewin's Change Management Model?

3 / 55

Which ophthalmic product is typically applied for prolonged contact and sustained release of medication?

4 / 55

Which statistical concept represents the middle value in a sorted list of numbers?

5 / 55

How does continuous monitoring contribute to pharmaceutical manufacturing?

6 / 55

When is a Process Capability Index with Centering (Cpk) value considered acceptable?

7 / 55

What is the purpose of setting appearance standards for primary packaging components?

8 / 55

What are the key components typically included in a Change Control Form?

9 / 55

Why is compliance with regulatory requirements essential for pharmaceutical Change Management?

10 / 55

What equipment can be used to measure the total vapour pressure of an aerosol container?

11 / 55

What is the significance of understanding and measuring process capability?

12 / 55

What is the purpose of the acceptance value (AV) in the content uniformity test?

13 / 55

What is the primary objective of the appearance quality control (Q test for ointments and creams?

14 / 55

Which of the following tests is used to determine particle size distribution in pharmaceutical aerosols?

15 / 55

What are the main features of Descriptive statistics?

16 / 55

What is the primary purpose of gels in ophthalmic formulations?

17 / 55

What is the vessel of choice when employing the hydrometer technique for density evaluation?

18 / 55

Which factor is NOT considered when selecting plastics in pharmaceutical preparations according to W H O guidelines?

19 / 55

Which regulatory authority oversees pharmaceutical products in the United States?

20 / 55

What is the purpose of the hydrolytic resistance test for glass containers?

21 / 55

Which metric measures the capability of a process to produce products within specification limits?

22 / 55

What property does Carton Opening Force Measurement evaluate?

23 / 55

Which spectroscopic technique involves the absorption, emission, or scattering of light, providing information about the chemical composition and structure of substances?

24 / 55

What is emphasized in 21 CFR Part 211 regarding pharmaceutical manufacturing?

25 / 55

Which type of flowchart illustrates the roles or departments responsible for different steps?

26 / 55

What does Coefficient of Friction Testing assess?

27 / 55

What is the purpose of conducting the pH determination test for ointments and creams?

28 / 55

Which method is used to assess the uniformity of volume in ophthalmic preparations?

29 / 55

How can histograms be used to analyze data across different groups or time periods?

30 / 55

How is the spray pattern of aerosols evaluated?

31 / 55

How does SPC help in continuous improvement through QMS?

32 / 55

What is the main emphasis of the assay and impurities test in ophthalmic pharmaceuticals?

33 / 55

Which test offers greater sensitivity, reliability, and specificity compared to the Rabbit Test?

34 / 55

Which technique may be employed to quantify moisture resistance in strip or blister packaging?

35 / 55

What is the expectation of the FDA regarding Root Cause Analysis (RCA) in pharmaceuticals?

36 / 55

What does a decision flowchart include?

37 / 55

What does Joint Shear Strength Testing evaluate?

38 / 55

What does Change Management involve in the pharmaceutical industry?

39 / 55

What is the purpose of Dimensional Testing in quality control testing procedures?

40 / 55

Which technique is capable of determining trace elements in various sample types by ionizing and analyzing them with inductively coupled plasma?

41 / 55

Which example illustrates the use of check sheets?

42 / 55

What is the main purpose of Electronic Change Management Systems (ECMS) in pharmaceutical organizations?

43 / 55

Which technique is utilized for measuring the dimensions of components like rubber plugs?

44 / 55

What is the primary objective of evaluating the coating applied to metallic tins for packaging?

45 / 55

What type of data does the Light Obstruction Particle Count Test provide regarding particulate matter?

46 / 55

In Pharmaceutical Analysis, what does High-Performance Liquid Chromatography (HPLC) separate and analyze?

47 / 55

Which of the following is NOT a common tonicity-adjusting agent for ophthalmic solutions?

48 / 55

How is the Flame Projection test conducted?

49 / 55

Which test evaluates whether a suppository exhibits brittle or elastic behavior under mechanical force?

50 / 55

What characterizes special cause variations?

51 / 55

Which of the following is a factor considered for process adjustments in tablet manufacturing optimization?

52 / 55

What is the main purpose of histograms?

53 / 55

Which property of paper and board is assessed through tests like tensile strength and tear resistance?

54 / 55

What are the key regulatory requirements for Root Cause Analysis (RCA) in pharmaceuticals?

55 / 55

In the membrane filtration method of sterility testing, what is the porosity of the membrane filters used?

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