MANUF VIOLET 1-100 || with Errorless Solutions 100%.
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Course
MANUF VIOLET 1-100
Institution
MANUF VIOLET 1-100
1. Active Pharmaceutical Ingredients (API) or bulk drug substance may be discovered or obtained by:
I. Synthetic biotechnology
II. Isolation from natural sources
III. Serendipitous new drug effect discovery
A. I only
B. III only
C. I and II
D. II and III
E. I, II and III correct answers E. ...
MANUF VIOLET 1-100 || with Errorless Solutions 100%.
1. Active Pharmaceutical Ingredients (API) or bulk drug substance may be discovered or
obtained by:
I. Synthetic biotechnology
II. Isolation from natural sources
III. Serendipitous new drug effect discovery
A. I only
B. III only
C. I and II
D. II and III
E. I, II and III correct answers E. I, II and III
2. Rx product life cycle phases that involves regulatory submission for additional dosage forms
or new therapeutic indications
A. Discovery
B. Development
C. Commercialization
D. Termination
E. None of these correct answers C. Commercialization
3. Which of the following phases of human clinical testing match with their description?
I. Phase I - testing the product in larger groups in patients with the disorder or disease
II. Phase Il - testing may also take place with special populations such as renal or hepatic
impairment, pediatrics or elderly subjects
III. Phase III - randomized, controlled testing on large patient populations to make definitive
assessment of drug efficacy
A. I only
B. Ill only
C. I and II
D. II and III
E. I, II and III correct answers B. Ill only
4. Practice of pharmacy that involved primarily with government regulations and policies
associated with all aspects of products
A. Marketing Manager
B. Medical Information Specialist
C. Public Policy Specialist
D. Regulatory Affairs Manager
E. Product Representative correct answers D. Regulatory Affairs Manager
5. Phase of human clinical trial testing that assess dosing requirements:
A. Phase II
B. Phase IIA
C. Phase IIB
D. Phase III
,E. Phase IV correct answers B. Phase IIA
6. Particle size is a basic property of a powder. Which of the following expression of diameter
that describes the distance between pairs of parallel tangents to the projected outline of the
particle in some fixed direction?
A. Martin's diameter, dm
B. Sieve diameter, da
C. Perimeter diameter, dp
D. Feret's diameter, df
E. Aerodynamic diameter, daero correct answers D. Feret's diameter, df
7. Expression of diameter that represents the particle size of a powder having the length of a
chord equally dividing the projected outline of the particle in some fixed direction
A. Martin's diameter, dm
B. Feret's diameter, df
C. Stokes diameter dst
D. Equivalent volume diameter, dv
E. Sieve diameter, da correct answers A. Martin's diameter, dm
8. This method is used to determine the diameter of a sphere having the same volume (V) as the
particle (Equivalent volume diameter, dv):
A. Sedimentation method
B. Anderson impactor method
C. Microscopic method
D. Coulter counter method
E. Light scattering method correct answers D. Coulter counter method
9. Which method is widely used to determine the crystallinity of a solid powder?
A. X-ray diffraction (XRD)
B. Angle of repose (a)
C. Photo correlation spectroscopy (PCS)
D. None of these
E. All of these correct answers A. X-ray diffraction (XRD)
10. If the % compressibility of a powder is 23-35%, the powder flowability is ___.
A. Extremely poor
B. Poor
C. Fair
D. Good
E. Excellent correct answers B. Poor
11. The function of Materials Inspection Section in a manufacturing plant is
I. To validate existing and tentative procedures of testing
II. To sample and examine all raw materials received
III. To maintain periodic examination on the quality of inventories throughout all phases of
storage, shipping and distribution
, A. I only
B. Ill only
C. I & II
D. II and III
E. I, II and III correct answers D. II and III
12. A classification of defect which may affect the function of the object and therefore, may
render the product useless (eg. presence of a crack in a bottle):
A. Internal defect
B. Major defect
C. Minor defect
D. Critical defect
E. Variable defect correct answers B. Major defect
13.A classification of defect which is not seen although present
A. Internal defect
B. Major defect
C. Minor defect
D. Performance defect
E. Attributable defect correct answers A. Internal defect
14. A suppository that does not melt at body temperature is an example of what defect?
A. Attributable defect
B. Variable defect
C. Performance defect
D. Internal defect
E. Critical defect correct answers C. Performance defect
15. The maximum percent defective or the maximum number of defects per hundred units that
for purposes of sampling Inspection, can be considered satisfactory as a process average
A. Acceptable quality level
B. Risks of error
C. Consumer's risk
D. Producer's risk
E. None of these correct answers A. Acceptable quality level
16. The process of optimizing a drug through the determination and/or definition of those
physical and chemical properties considered important in the formulation of a stable, effective
and safe dosage form:
A. Batch formula
B. Master formula
C. Formulation
D. Preformulation
E. None of these correct answers D. Preformulation
17. Purified water, USP is water obtained by
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