Quality Assurance & Quality Control

A set of 300 Question-and-Answer style flashcards covering key concepts, definitions, calculations, tests, and regulatory aspects from the Module 6 lecture on Pharmaceutical Quality Assurance and Quality Control.

1. What is the pharmaceutical definition of “quality” for a product?

The totality of features or conformance to specifications ensuring the product is fit for intended use, safe, and compliant with marketing authorization.

2. Which three key attributes must a quality pharmaceutical product possess?

Fitness for intended use, safety, and compliance with regulatory requirements.

3. What does TQM stand for in pharmaceutical manufacturing?

Total Quality Management.

4. Define Total Quality Management (TQM).

A combined team effort to develop, produce, market, distribute, and control products that remain safe and effective throughout their marketplace life.

5. What is Quality Assurance (QA)?

The totality of organized arrangements intended to ensure products are of the quality required for their intended use.

6. CGMP is an acronym for what phrase?

Current Good Manufacturing Practice.

7. How is CGMP related to QA?

CGMP is the part of QA that ensures products are consistently produced and controlled to appropriate quality standards.

8. What does QC stand for?

Quality Control.

9. Give a concise definition of Quality Control (QC).

The CGMP component concerned with sampling, specifications, testing, organization, documentation, and release procedures.

10. What does PQR mean?

Product Quality Review.

11. Why are Product Quality Reviews performed?

To verify process consistency and identify product or process improvements through periodic review of all registered drug products.

12. What does QRM stand for?

Quality Risk Management.

13. Define Quality Risk Management.

A systematic process for assessing, controlling, communicating, and reviewing risks to product quality.

14. What is the purpose of a pharmaceutical Quality Unit?

To independently fulfill both QA and QC responsibilities separate from Production.

15. Name two primary responsibilities of a QA unit.

Ensuring quality policies are followed and acting as primary contact with regulatory agencies.

16. Name two primary responsibilities of a QC unit.

Conducting sampling and testing of raw materials & finished products, and performing environmental monitoring.

17. What is a monograph in QC documentation?

A document that specifies all tests to be conducted on a material and the expected results.

18. What does SOP stand for?

Standard Operating Procedure.

19. Define Standard Operating Procedure (SOP).

A step-by-step written instruction for performing a specific task or activity.

20. What information does a Certificate of Analysis (COA) provide?

Actual results of all tests conducted on a material, demonstrating compliance with standards.

21. What is contained in an MSDS?

Information on potential health effects of chemical exposure and safe handling procedures.

22. In sampling, what does the symbol n represent?

The number of items removed from the population for testing.

23. Provide the easy square-root sampling equation.

n = √N + 1, where N is the population size.

24. Identify the most common old military sampling plan.

MIL-STD-105E.

25. Name the newer common civilian sampling standard.

ANSI/ASQ Z1.4-2008.

26. What is a control chart used for?

Graphically plotting product quality as manufacturing proceeds.

27. Which control chart tracks the proportion of defectives?

p-Chart.

28. Which control chart tracks the actual number of defectives?

np-Chart.

29. Which control chart is applied to measurable characteristics?

X-bar chart.

30. What does crossing the action limit on a control chart signal?

The process must be stopped and corrective action taken.

31. Define validation in pharmaceutical processes.

Documented proof that a process, procedure, or method actually leads to expected results.

32. Define qualification with respect to equipment.

Proof that premises, systems, or equipment work correctly and achieve expected results.

33. What is a critical defect?

A defect that may endanger the life of a patient.

34. Distinguish a major defect from a minor defect.

Major affects product function without endangering life; minor affects neither life nor function.

35. Differentiate variable defects from attributive defects.

Variable defects are measured instrumentally; attributive defects by visual inspection.

36. What is a Class I recall?

Removal of product that may cause death or serious adverse health consequences.

37. What shelf-life potency level is considered the minimum acceptable?

90% of labeled potency.

38. Name three principal pathways of drug product decomposition.

Hydrolysis, oxidation, and photolysis.

39. How can hydrolysis decomposition be prevented?

Reduction or elimination of water in the preparation.

40. How can oxidation be mitigated in formulations?

Use of antioxidants such as vitamins C and E.

41. How is photolysis minimized?

Using light-resistant containers.

42. Provide the formula for expiration date.

Expiration Date = Manufacturing Date + Shelf-life (t90).

43. Which equation is used to estimate shelf-life during stability studies?

Arrhenius equation.

44. State the temperature and humidity for Climatic Zone I.

21 ± 2 °C and 45 ± 5 % RH.

45. Which countries typically fall in Climatic Zone IVB?

Philippines and other hot, very humid Asian countries.

46. How long is the testing period for accelerated stability studies?

0, 3, and 6 months.

47. What is the purpose of stress testing in stability studies?

To reveal intrinsic stability and identify likely degradation products under severe conditions.

48. What color label is assigned to quarantined raw materials?

Yellow.

49. What warehouse distribution rule follows “first stock in moves out first”?

FIFO – First-In, First-Out.

50. What does FEFO stand for in warehouse management?

First Expiry-First Out.

51. State two chemical identification methods for raw materials.

Color reactions and precipitation tests.

52. Name two instrumental identification methods for raw materials.

Spectroscopy and chromatography.

53. What is the goal of an assay in RMQC?

To determine the amount of active pharmaceutical ingredient or biologic activity.

54. Which animal is used for digitalis bioassay?

Pigeon.

55. Which microbial assay method relies on a zone of inhibition on an agar plate?

Cylinder plate (or paper disc) method.

56. What reagent is used in the limit test for heavy metals?

Hydrogen sulfide test solution.

57. Which reagent is specific for arsenic limit testing?

Silver diethyldithiocarbamate TS.

58. What instrument measures refractive index in QC?

Abbe refractometer.

59. Give the solubility descriptive term for a substance requiring fewer than 1 part solvent per 1 part solute.

Very soluble.

60. At what temperature range is loss on drying by gravimetry done for organic materials?

105 °C.

61. Name the main chemical component of Karl-Fischer reagent responsible for water reaction.

Sulfur dioxide.

62. Provide the general formula for % water in Karl-Fischer titrimetry.

% Water = (V × F) / Wt × 100.

63. In glass testing, which type of glass is highly resistant borosilicate?

Type I glass.

64. What is the light-transmission limit for colored glass containers between 290–450 nm?

Not more than 10%.

65. Which test distinguishes Type I glass from Types II and III in new USP methodology?

Glass Grains Test.

66. Which animal is used in the systemic injection test for plastics bioreactivity?

Albino mice.

67. Which in-vitro plastic reactivity test uses an agar diffusion method?

Agar Diffusion Test.

68. Name two optical microscopy diameter measurements used in particle-size analysis.

Ferret diameter and Martin diameter.

69. What is the relationship between mesh number and sieve opening size?

Higher mesh number equals smaller particle size.

70. What sieve analysis endpoint is accepted when weight change is <5 %?

Sieving is complete for that sieve.

71. In density testing, which volumetric method uses a Scott volumeter?

Bulk density Method II.

72. What is the maximum allowed difference between V500 and V1250 in tapped density?

Not more than 2 mL.

73. Provide the formula for porosity based on bulk and granule volumes.

Interparticle Porosity = (Vb – Vg) / Vb × 100.

74. State the formula for Carr’s index.

CI (%) = (Vb – Vt) / Vb × 100 or (Dt – Db) / Dt × 100.

75. What Hausner ratio indicates excellent flowability?

1.00–1.11.

76. Define angle of repose.

The maximum angle between the surface of a powder cone and the horizontal plane.

77. What minimum hardness is acceptable for conventional uncoated tablets?

4 kg.

78. Which hardness tester uses a spring mechanism?

Stokes (Monsanto) tester.

79. What is the thickness acceptance range for tablets?

±5 % of the set standard thickness.

80. During friability testing, how many revolutions are standard?

100 revolutions (25 rpm for 4 min).

81. State the maximum friability loss for new tablet formulations.

Not more than 0.8%.

82. For weight-variation testing, what is the tolerance for tablets averaging 200 mg?

±7.5 % (because 130–324 mg range).

83. In content uniformity, what percentage range must each unit fall within?

85–115 % of label claim.

84. Define complete disintegration.

No palpable firm core remains; only a soft mass of insoluble residue on the screen.

85. What is the maximum disintegration time for an uncoated immediate-release tablet?

30 minutes.

86. Which USP dissolution apparatus uses a basket?

Apparatus I.

87. What is the standard paddle speed for Apparatus II dissolution?

50 rpm.

88. At dissolution Stage 1, what requirement must each of the first six units meet?

Each unit must be at least Q + 5 %.

89. Define Q in dissolution testing.

The percentage of labeled content specified in the monograph to be released.

90. For capsules, which three FPQC tests mirror tablet tests?

Dosage-unit uniformity, disintegration, and dissolution.

91. Name two FPQC tests specific to semisolid dosage forms.

Spreadability and minimum fill.

92. What microbial organisms must topical semisolids be free from?

Pseudomonas aeruginosa and Staphylococcus aureus.

93. For minimum fill testing, what is the acceptance criterion for non-aerosol semisolids labeled at 120 g?

Net content must be ≥ 95 % of label claim.

94. How many metal particles ≥50 μm are allowed in total for 10 ophthalmic ointment tubes?

Fewer than 50 in total, and not more than one tube with >8 particles.

95. List three general FPQC tests common to all dosage forms.

Identification, assay, and pH.

96. Which FPQC test measures deliverable volume for liquid products?

Deliverable volume test using specified drainage times.

97. What does a sedimentation volume (F) of 1 signify in suspensions?

Ideal suspension with no sediment, no caking, and aesthetically pleasing appearance.

98. Calculate sedimentation volume using the formula.

F = Vu / Vo, where Vu is settled volume and Vo is total suspension volume.

99. Define degree of flocculation (β).

β = Ffloc / Fdefloc = Vu / V∞; compares flocculated to deflocculated sedimentation volumes.

100. Name one test used to differentiate W/O from O/W emulsions.

Dilution test (W/O not miscible with water).