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Pyrogenic Reaction and Quality Control Insights

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0% found this document useful (0 votes)
353 views12 pages

Pyrogenic Reaction and Quality Control Insights

Uploaded by

Renesmae Gonzaga
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

MODULE 6 (meta)

Study online at [Link]


1. In one of the typhoon evacuation centers, an outbreak of sepsis
suspected to be caused by Staphylococcus aureus occurred. One
of the pharmacists in the health sector volunteer group was called
upon to assist in the investigation.
Where would be the most likely reservoir of the organism in the
B
normal flora?
A. Throat
B. Nose
C. Colon
D. Genitalia
2. What is the route of transmission of monkeypox?
i. Direct contact with monkeypox rash, scabs, or body fluids from
a person with monkeypox.
ii. Touching objects, fabrics (clothing, bedding, or towels), and
surfaces that have been used by someone with monkeypox.
iii. Contact with respiratory secretions D
iv. Mother to developing fetus
A. I only
B. II only
C. I and II
D. I, II, III, and IV
3. What is the 6th Millennium Developmental Goal?
A. Improve maternal Health
B. Eradicate extreme poverty and hunger C
C. Combat HIV/AIDs, malaria and other diseases
D. Promote gender equality and empower women
4. Which of the following statements are true as results of contam-
ination of biological products, which can compromise medication
or treatment?
I. Loss of potency due to degradation
II. Increase level of bacterial endotoxin III. Increase medication
cost D
IV. Shortage of essential drug Product
A. I, II, & III
B. I, II, III, & IV
C. II, III & IV
D. I,II&IV
5. Which of the following statements will BEST describe Epidemi-
ology as a core of Public Health service?
A. Study of occurrence of disease and calamities
B. Study of development of policies and plans at the community
level D
C. Study of distribution and determination of diseases and disabil-
ity on patient level
D. Study of distribution and determinants of disease and disability
at the population level
6. Which of the following has been identified by DOH as the most
common diseases acquired through ingestion of contaminated
drinking water in the Philippines for the past two years?
I. Typhoid fever
II. Dengue
D
III. Cholera
A. II, III
B. I,II
C. I, II, III
D. I, III
7. Methicillin- resistant Staph aureus (MRSA) is a group of
Staphylococcus aureus strains identified as a major cause of
health care infections (HCAIs) such as which of the following?
I. Wound and soft tissue infection
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MODULE 6 (meta)
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II. Catheter associated UTI
III. Colitis
IV. Ventilator Associated Pneumonia
A. I, II, IV A
B. I, II, III, IV
C. I, II, III
D. II, III, IV
8. What is the typical range of acceptance criteria for assay results
as found in the labeled claim?
A. 90-110%
A
B. 85-115%
C. 75-125%
D. 95-105%
9. Which of the following microorganisms, do you expect to be the
MOST resistant to high temperatures?
I. Staphylococcus aureus
II. Clostridium botulinum
III. Bacillus subtilis
C
IV. Escherichia coli
A. I and II
B. I and III
C. II and III
D. All of the above
10. The period of stability of a preparation is the time from the date
of manufacture of the formulation until its biological or chemical
activity is no less than how many percent of the labeled potency?
A. 85% D
B. 95%
C. 80%
D. 90%
11. What chemical reaction is involved during an analysis wherein
there occur a change of valence of reacting substances?
A. Oxidation- reduction
A
B. Precipitation
C. Neutralization
D. Complexation
12. In microbial assay of antibiotics, what organism is used for
penicillin G?
A. Escherichia coli
B
B. Staphylococcus aureus
C. Bacillus subtilis
D. Pseudomonas aeruginosa
13. Which among the following laws is a fundamental law of
fluorometry in the analysis of drugs?
A. Law of mass action
C
B. Boyle's law
C. Beer's law
D. Newton's law
14. Which type of chemical analysis measures percentage content
of the component present in a given sample?
A. Quantitative method
A
B. Qualitative method
C. Proximate method
D. Gravimetric method

15. Which of the following are identified as functions of quality


control as a major component of CGMP?
I. Sampling, specifications and testing C
II. Documentation and Release Control III. Audit
IV. Stock control

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MODULE 6 (meta)
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A. I, II, & III
B. I, II, III, & IV
C. I,II&IV
D. II, III & IV
16. Functions of Quality Control include the following, EXCEPT
_________.
A. Analytical control
D
B. Inspection control
C. Stock control
D. Audit
17. Which of the following control function is not a quality control
(QC) function?
A. In-process analysis
C
B. Labeling and packing materials
C. Inventory control
D. Inspection of containers
18. In qualitative analysis where would adsorption indicators be
used?
A. Complexation reaction
B
B. Volumetric precipitation
C. Acidimetry
D. Alkalimetry
19. The ash content of an organic compound is an impurity of
_____.
A. Oil
C
B. Volatile content
C. Inorganic matter
D. Carbon
20. In the drugstore when a customer would ask a pharmacist,
what is a disinfectant; which of the following is the best statement
as answer?
A. A chemical agent that kills both vegetative forms and spores of
pathogens B
B. A chemical agent that eradicates microorganisms
C. A chemical agent that kills vegetative forms of pathogens but
not spores
D. A substance that serves as a cleansing agent
21. The primary standard used to standardize Karl Fischer
reagent is:
A. Potassium Bitartrate
D
B. Sodium oxalate
C. Sodium carbonate anhydrous
D. Sodium tartrate
22. Which among the following list of indicators is NOT used in
acid based titrations?
A. Methyl red
B
B. Ferric alum
C. Phenolphthalein
D. Methyl orange
23. Public health activities of pharmacist on a micro level would
include which of the following
[Link] the public on health and medication
[Link] and development of health policies for the community
[Link] patients about chronic conditions
A
[Link] information services and publication of health promotions
A. I, III
B. I, III, IV
C. I,II
D. I, II, III

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MODULE 6 (meta)
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24. Choose the solvent that is used in azeotropic method of water
analysis?
A. Alcohol
B
B. Xylene
C. Ethylene glycol
D. Acetone
25. When an alkaloid is subjected to titration ultimate assay
method, what are possible types of titration based on the number
of volumetric solutions?
A. Direct titration and blank titration B
B. Direct and residual titration
C. Back and blank titration
D. Residual and back titration
26. What is the acid necessary for permanganate titrations?
A. Nitric acid
B. Hydrochloric acid D
C. Acetic acid
D. Sulfuric acid
27. What quantitative measure would the iodine value of an oil
express?
A. Unsaponifiable matter
C
B. Phenol content
C. Unsaturated fatty acids
D. Saturated fatty acids
28. Which of the following are the most basic principles upon
which chromatographic separations take place?
I. Absorption
II. Ion-exchange
III. Adsorption
B
IV. Partition coefficient
A. I, II, III, & IV
B. II, III & IV
C. I,II&III
D. I,II&IV
29. Which of the following risk assessment methods are currently
to reduce pyrogen particles and microbial contamination during
manufacture of pharmaceutical products?
I. Hazard Analysis Critical Control Points (HACCP)
II. Fault Tree Analysis (FTA)
III. Force Field Analysis (FFA) D
IV. IV. Failure Mode and Effects Analysis (FMEA)
A. II and IV
B. I and IV
C. I and II
D. I, II and IV
30. Which of the following terms to the functional group of an
organic molecule that absorbs maximum radiation in UV or IR
regions?
A. Chromopore A
B. Carbonyl
C. Thiol
D. nitrile
31. Promoting the "four o'clock habit", is all about the DOH pro-
gram for prevention and control of which of the following disease?
A. Malaria
D
B. Malnutrition
C. Tuberculosis
D. Dengue

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MODULE 6 (meta)
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32. Which of the following type of chromatographic analysis uti-
lizes cellulose of filter paper as the adsorbent?
A. Paper chromatography
A
B. Gas chromatography
C. Thin layer chromatography
D. Column chromatography
33. Which of the following are components of a blank titration
analysis?
I. Solvent
II. Reagent
III. Indicator
D
IV. Analyte
A. I, II, III, & IV
B. I,II&IV
C. II, III & IV
D. I,II&III
34. The crude fiber of a drug is usually composed of _____.
A. Cellulose
B. Phytosterol A
C. Fixed oils
D. cholesterol
35. The United States Pharmacopeia(USP) content uniformity test
is used to ensure which quality?
A. Bioequivalence
C
B. Purity
C. Potency
D. Toxicity
36. What does the principle of total quality mean in pharmaceutical
preparations?
A. Production is responsible for quality
C
B. Use of state-of-the-art equipment
C. Quality is everybody business
D. Quality combines with strict adherence to standards
37. Which of the following descriptors represents the index that
measures the number of individuals who have died within a sus-
ceptible population during a specific period because of a particular
disease?
C
A. Prevalence rate
B. Virulence
C. Mortality rate
D. Morbidity rate
38. Which of the following has been identified to be microbial
contaminant in hand cream?
A. Pseudomonas aeruginosa
C
B. Coliforms
C. Klebsiella pneumonia
D. Clostridium tetani
39. Good manufacturing practice(GMP) as part of quality assur-
ance simply means ________.
A. All records and documentation must be in place.
D
B. Environmental cleanliness and hygiene must be observed.
C. Personnel must be properly trained
D. It is about getting things right all along the time

40. In methods of analysis which of the following refers ability of


the procedure to provide analytical results of acceptable accuracy
and precision under a variety of conditions C
A. Precision
B. Accuracy

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MODULE 6 (meta)
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C. Robustness
D. specificity
41. Which among statements BEST describe qualification as a
major component of quality assurance?
A. Action of proving that any premises systems and items of
equipment work correctly and actually lead to expected results.
B. Involves evaluation of past experiences of production showing
A
that everything is unchanged.
C. Documented verification that the system or subsystem preform
as intended of its overall anticipated operating range.
D. A list of detailed requirements with which the materials used or
products obtained during manufacture have to conform.
42. What is used in assessing efficiency of HEPA filter?
A. Rodac plate test
B. Bubble point test D
C. Powdered glass test
D. DOP test
43. Which of the following processes refers to changing optical
active compound to a non-optically active substance?
A. Epimerization
C
B. Diazotization
C. Racemization
D. Complexation
44. For quality control assays are periodically validated for follow-
ing characteristics, EXCEPT____.
A. Robustness and stability
B
B. Marketability and affordability
C. Specificity and range
D. Accuracy and precision
45. Quality Assessment tools for non-sterile dosage forms specific
for suppositories, troches, lozenges include?
I. Weight and Weight variations
II. Color of preparation
III. Clarity (Visual)
B
IV. Appearance, feel
A. I,II&III
B. I, II, III, & IV
C. I,III&IV
D. II, & IV only
46. Which of the following are major contributors of health care
associated infections?
I. Failure of health care personnel to follow hand washing protocols
II. Smoking and alcoholism
III. Increased number of immune compromised patients A
A. I, III
B. I,II
C. II, III
D. I, II, III
47. Which of the following are examples of adventitious agents
found to be possible contaminants of biological products?
I. Ants
II. Fungi
III. Bacteria
D
IV. Viruses
A. I,II&III
B. I, II, III, & IV
C. I,II&IV
D. II, III & IV

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MODULE 6 (meta)
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48. Which of the following refers to a list of test references which
are critical quality standards for purity and safety of pharmaceu-
tical products?
A. Validation characteristics C
B. Descriptions
C. Specifications
D. Assay
49. What constitutes the mobile phase used in thin layer chro-
matography (TLC)?
A. Alumina
C
B. Cellulose
C. Aqueous salt solution
D. Silica gel
50. Which of the following chemical interactions is recognized as
a major cause for product instability?
A. Acetylation
D
B. Deamination
C. Decarboxylation
D. Oxidation-Reduction
51. The analyst computation of loss on drying test is 0.08% above
the specified maximum limit. Determine the total weight loss if the
retained sample weight is 9.374 g. Product monograph allow only
a 1.5%.
B
A. 0.140 g
B. 0.150 g
C. 0.0007 g
D. 0.48 g
52. What is the range of heating glassware in order to destroys
pyrogens?
A. 180 degrees for 4minutes
D
B. 100 degrees for an hour
C. 250 degrees for 45 seconds
D. 650 degrees for 60 seconds
53. In the assay of Dextran injection where in the activity assayed
is the absorption of iron, what is the test animal used?
A. Rabbit
A
B. Mice
C. Guinea pig
D. Tissue culture
54. The following are units of measurement generally used in
spectrometry, EXCEPT___.
A. Milliliter
B
B. Photometer
C. Micrometer
D. Nanometer
55. Which of the following is a process of gene transfer where the
carrier of DNA is a virus
A. Sporulation
D
B. Conjugation
C. Transformation
D. Transduction
56. Which of the following is the formation of dormant form of
bacteria when conditions are inhospitable?
A. Mutation
D
B. Polymorphism
C. Germination
D. Sporulation
57. The method of assay for sulfonamidesis:
A. Kjeldahl method
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MODULE 6 (meta)
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B. Diazotization method
C. Gravimetric analysis B
D. Titrimetric analysis
58. Regarding Pasteur's experiment with the S-neckflask, all of the
following statements are true, EXCEPT _____.
A. All microorganisms were killed before beginning.
C
B. There was food source involved.
C. There was absence of air.
D. Any possibility of contamination was removed.
59. The addition of untreated sewage to a freshwater lake would
cause the biochemical oxygen demand to________.
A. Can't tell
B
B. Increase
C. Decrease
D. Stay the same
60. Which of the following is not gram-positive?
A. Corynebacterium
B. Bacillus D
C. Staphylococcus
D. Treponema
61. Which of the following lacks a cell wall?
A. Mycoplasma
B. Mycobacterium A
C. Clostridium
D. Nocardia
62. Which of the following is the identified cause of Hansen's
disease?
A. Mycoplasma leprae
B
B. Mycobacterium leprae
C. Mycobacterium bovis
D. Mycobacterium tuberculosis
63. The indicator used in permanganate titrations:
A. Phenolphthalein
B. Hydroxynapthol blue D
C. Starch TS
D. Potassium permanganate
64. The primary natural nutrients of bacteria are:
A. Nucleic acids/chitin/peptidoglycans
B. Carbohydrates/amino acids/lipids B
C. Carbohydrates/nucleic acids/steroids
D. Lipids/polysaccharides/lactoferrin
65. How is avian flu or bird flu transmitted?
A. Direct or indirect contact with infected birds
B. Inhalation of contaminated aerosols A
C. Animal bites viz; clogs, cats
D. Mosquito bites
66. Which of the following is caused by an opportunistic pathogen
for compromised systems?
A. Trichomoniasis
B
B. Candidiasis
C. Gonorrhea
D. Genital herpes
67. Which of the following substances can sterilize?
A. Alcohols
B. Chlorine D
C. Soap
D. Ethylene oxide

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MODULE 6 (meta)
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68. Which of the following substances is the LEAST effective
antimicrobial agent?
A. Iodine
C
B. Cationic detergents
C. Soap
D. Phenolics
69. A process where in the sample is made to liberate iodine,
which is then titrated with a standard solution of sodium thiosul-
fate:
A. Cerimetry D
B. Iodimetry
C. Diazotization method
D. Iodometry
70. Causative agent of typhoid fever is______.
A. Salmonella
B. Aspergillus A
C. Shigella
D. Rickettsia typhi
71. In gram staining, a bacterial cell that will stain pink to red, the
specimen will be labeled as___.
A. Gram negative
A
B. Pink is not an observed color in gram stain
C. Gram positive
D. Gram variable
72. Using a spectrophotometer to measure the concentration of
sample, the following data were obtained:
Absorbance of standard solution = 0.225 Absorbance of sample
solution = 0.214 Concentration of Std solution =17.7 ¼
g
C
A. 18.6¼
g
B. 19.0 ¼
g
C. 16.8 ¼
g
D. 16.9 ¼
g
73. Leptospirosis can commonly be obtained in infected_____
A. Flood waters
B. Toxins in drugs A
C. Air droplets
D. Blood transfusion
74. Malic acid present in cherry juice may be determined by:
A. Direct Permanganometry
B. Indirect Permanganometry B
C. Residual Permanganometry
D. Iodimetry`
75. Which of the following is a hybrid plasmid used as cloning
vector in genetic engineering for large pieces of DNA?
A. Cosmids
A
B. Cos gene
C. Fosmids
D. Lambda phage
76. Place the following surfactants in order from the most effec-
tive to the least effective antimicrobial activity: 1-soap; 2-Anionic
detergent; 3-cationic detergent
A. 1,2,3 B
B. 3,2,1
C. 2,3,1
D. 3,1,2
77. LAL test is applicable in the determination of:
A. Microorganism
B
B. Pyrogens
C. Chemical impurities
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MODULE 6 (meta)
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D. All of these
E. None of thes
78. Which causes athlete's foot?
A. Tinea capitis
B. Tinea corporis C
C. Tinea pedis
D. Tinea cruces
79. The solvents for fats and fixed oils
A. H2O
B. N-hexane B
C. 80% ethanol
D. 95% ethyl alcohol
80. Which of the following microorganisms are used as probiotics?
I. Lactobacillus spp
II. Bacillus fumidus
III. Bifidobacteria
C
A. I
B. I and II
C. I and III
D. II
81. Which of the following are identified worldwide as 'ESKAPE'
pathogen's
I. Enterococcus faecium
II. Acinetobacter baumanii
III. Candida albicans
D
IV. Pseudomonas aeruginosa
A. I, II, III, & IV
B. I,II&III
C. II, III & IV
D. I,II&IV
82. Content uniformity is to be performed for all the tablets whose
active ingredient is:
A. 50 mg or less
A
B. Less than 100 mg
C. 50mg to 100 mg
D. More than 50 mg
83. Which type of industrial hazard includes ambient heat, burn,
noise and vibration?
A. Physical
A
B. Chemical
C. Local
D. Biological
84. Which is measured by the biochemical oxygen demand?
A. The amount of oxygen present in water sample
B. The number of bacteria present in a water sample
C
C. The amount of organic matter present in a water sample
D. The amount of undissolved solid matter present in a water
sample
85. Which component of milk has antibodies?
A. Lactose
B. Cream of milk C
C. Colostrum
D. fructose
86. Choose the reservoir for chicken pox infection.
A. Pigs
B. Humans B
C. Chicken
D. Cattles

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87. Determine the iodine value of a sample of olive oil weighing
0.2100g if 24.15 mL and 12.00mL of 0.1100 N sodium thiosul-
fate solution which are required for blank and residual titrations
respectively.
D
A. 80.5%
B. 80.6%
C. 80.7%
D. 80.8%
88. Which of the following is common route of transmission for
COVID-19, SARS and common cold?
A. Needlestick injury
B
B. Handshake
C. Animal bites
D. Contact with contaminated urine
89. Theories and models used in health promotion programs and
interventions include which of the following?
I. Ecological model
II. Health belief model
III. Stages of change model D
A. I, III
B. II, III
C. I,II
D. I, II, III
90. These diseases are Sexually Transmitted Infections, EX-
CEPT_______.
A. Gonorrhea
D
B. AIDS
C. Syphilis
D. Hepatitis A
91. The following are zoonotic diseases, EXCEPT___.
A. Anthrax
B. Mumps B
C. Brucellosis
D. leptospirosis
92. Which of the following drugs should be avoided for patients
with dengue hemorrhagic fever?
A. Insulin
C
B. Chloramphenicol
C. Aspirin
D. Paracetamol
93. Public health activities for pharmacists at a micro level include
the following.
I. Educating patients and clients on wellness
II. Research and development of health policies for the community
III. Counseling patients about chronic conditions B
A. I, II, III
B. I, III
C. II, III
D. I,II
94. Symptoms of the severe disease known as Ebola include the
following, EXCEPT____.
A. Frequent urination
A
B. Muscle pain and weakness
C. Fever and severe headache
D. Diarrhea and vomiting

95. Find the acid number of a rosin sample weighing 1.100g which
required 28.00mL of 0.1100 N NaOH to bring about the end point.
B
A. 157.0
B. 157.1

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C. 157.2
D. 157.3
96. What is the component of starch that reacts with iodine to form
the intensely blue-colored solution?
A. Alpha-amylose
B
B. Beta-amylose
C. Amylopectin
D. Both A and B
97. The following pharmaceutica lexcipients affect the disintegra-
tion of tablets, EXCEPT:
A. Binders
B
B. Colorants
C. Granulating agents
D. Disintegrants
98. Turbidimetric and nephelometric method of assay analyzed
what type/s of sample?
A. Suspension
D
B. Solution
C. Turbid solution
D. Both A and C
99. In the repeat test for pyrogens using a total of eight rabbits, the
requirement is met if the total rise in temperature is:
A. Less than 3.3 °C
C
B. Equal to 3.3°C
C. Equal to or less than 3.3°C
D. Equal to or more than 3.3°C
100. What tablet attribute is correlated with the biological activity
of the active ingredients?
A. Hardness
B
B. Dissolution
C. Friability
D. Disintegration

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