BTEC 3320 EXAM 1 UPDATED QUESTIONS AND VERIFIED
ANSWERS
A drug...shall be deemed adulterated...if...the methods used in, or the facilities or controls used for its
manufacture, processing, packing, or holding, do not conform to, or are not operated or administered in
conformity with current good manufacturing practice to assure that such drug meets the requirements
of this Act as to safety and has the identity and _____________ and meets the quality and
______________ characteristics, which it purports or is represented to possess."
solution:palatability
strength:potency
stability:purity
strength:purity
stability:potency
solubility:purity - CORRECT ANSWER✅✅✅strength:purity
What has nothing to do with the Biologics Control Act of 1902?
Inadequate procedures and testing of serum products by local officials
Human trials that showed the health effects of commonly used meat preservatives
"Tetanus-contaminated diphtheria antitoxin preparation from a horse named, Jim"
Required the inspection of establishments where biological products are manufactured
Required the licensing of establishments where biological products are manufactured - CORRECT
ANSWER✅✅✅Human trials that showed the health effects of commonly used meat preservatives
"In the eyes of the FDA , the quality of drugs and devices can be assured by adherence to:"
laws and guidances
regulations and guidances
laws and regulations
current good manufacturing practices
all the other choices are correct - CORRECT ANSWER✅✅✅all the other choices are correct
,"Continuous _________________ is essential for an organization to maintain current levels of
performance, to react to changes in its internal and external conditions, and to create new
opportunities."
Training
Change
Examination
Improvement
Order
Promotion - CORRECT ANSWER✅✅✅Improvement
The main objective of ICH is to:
standardize the technical requirements for the registration of pharmaceuticals
harmonize the supply of products for human consumption
eliminate the requirement for clinical testing of pharmaceuticals in humans
"reduce the cost of drug and device maufacturing in Europe, Japan, and US"
"standardize the pricing of drugs for human use in Europe, Japan, and US" - CORRECT
ANSWER✅✅✅standardize the technical requirements for the registration of pharmaceuticals
"According to the International Organization for Standardization (ISO), a _______________ is a
document that provides requirements, specifications, guidelines or characteristics that can be used
consistently to ensure that materials, products, processes and services are fit for their purpose."
Batch record
Product insert
SOPs
Standard
Certificate of analysis
Product label - CORRECT ANSWER✅✅✅Standard
"The US Pharmacopeia is not, or does not:"
sets standards for prescription drugs
, provides documents describing acceptable tests and passing criteria for drug components
provide standards for medical devices and dietary supplements
sets standards for over the counter drugs
manufacture prescription drugs for patient use - CORRECT ANSWER✅✅✅manufacture prescription
drugs for patient use
"Drugs, unlike devices, :"
are mostly metabolized to achieved their intended medical uses
are intended to affect the structure or any function of the body of man.
"are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man "
"can be an instrument, implement, machine, implant, or in vitro reagent"
exert their effects locally - CORRECT ANSWER✅✅✅are mostly metabolized to achieved their
intended medical uses
What is not true of cGMPs?
cGMPs apply to both marketed and investigational drugs
cGMPs apply to drugs and devices
cGMPs include guidelines in ICHE6
cGMPs includes Acts passed by the US Congress
cGMPS require compliance with regulations found in CFR21 Part 211 - CORRECT
ANSWER✅✅✅cGMPs include guidelines in ICHE6
What is not a benefit in external market that comes with ISO certification?
ISO certification leads to decreased advantage over a competing product
ISO certification can lead to increased market share
ISO certification can lead to less need for purchasers to perform quality audits
ISO certification leads to perception of higher product quality by consumers
ISO certification can reduce the time needed to market a product - CORRECT ANSWER✅✅✅ISO
certification leads to decreased advantage over a competing product
ANSWERS
A drug...shall be deemed adulterated...if...the methods used in, or the facilities or controls used for its
manufacture, processing, packing, or holding, do not conform to, or are not operated or administered in
conformity with current good manufacturing practice to assure that such drug meets the requirements
of this Act as to safety and has the identity and _____________ and meets the quality and
______________ characteristics, which it purports or is represented to possess."
solution:palatability
strength:potency
stability:purity
strength:purity
stability:potency
solubility:purity - CORRECT ANSWER✅✅✅strength:purity
What has nothing to do with the Biologics Control Act of 1902?
Inadequate procedures and testing of serum products by local officials
Human trials that showed the health effects of commonly used meat preservatives
"Tetanus-contaminated diphtheria antitoxin preparation from a horse named, Jim"
Required the inspection of establishments where biological products are manufactured
Required the licensing of establishments where biological products are manufactured - CORRECT
ANSWER✅✅✅Human trials that showed the health effects of commonly used meat preservatives
"In the eyes of the FDA , the quality of drugs and devices can be assured by adherence to:"
laws and guidances
regulations and guidances
laws and regulations
current good manufacturing practices
all the other choices are correct - CORRECT ANSWER✅✅✅all the other choices are correct
,"Continuous _________________ is essential for an organization to maintain current levels of
performance, to react to changes in its internal and external conditions, and to create new
opportunities."
Training
Change
Examination
Improvement
Order
Promotion - CORRECT ANSWER✅✅✅Improvement
The main objective of ICH is to:
standardize the technical requirements for the registration of pharmaceuticals
harmonize the supply of products for human consumption
eliminate the requirement for clinical testing of pharmaceuticals in humans
"reduce the cost of drug and device maufacturing in Europe, Japan, and US"
"standardize the pricing of drugs for human use in Europe, Japan, and US" - CORRECT
ANSWER✅✅✅standardize the technical requirements for the registration of pharmaceuticals
"According to the International Organization for Standardization (ISO), a _______________ is a
document that provides requirements, specifications, guidelines or characteristics that can be used
consistently to ensure that materials, products, processes and services are fit for their purpose."
Batch record
Product insert
SOPs
Standard
Certificate of analysis
Product label - CORRECT ANSWER✅✅✅Standard
"The US Pharmacopeia is not, or does not:"
sets standards for prescription drugs
, provides documents describing acceptable tests and passing criteria for drug components
provide standards for medical devices and dietary supplements
sets standards for over the counter drugs
manufacture prescription drugs for patient use - CORRECT ANSWER✅✅✅manufacture prescription
drugs for patient use
"Drugs, unlike devices, :"
are mostly metabolized to achieved their intended medical uses
are intended to affect the structure or any function of the body of man.
"are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man "
"can be an instrument, implement, machine, implant, or in vitro reagent"
exert their effects locally - CORRECT ANSWER✅✅✅are mostly metabolized to achieved their
intended medical uses
What is not true of cGMPs?
cGMPs apply to both marketed and investigational drugs
cGMPs apply to drugs and devices
cGMPs include guidelines in ICHE6
cGMPs includes Acts passed by the US Congress
cGMPS require compliance with regulations found in CFR21 Part 211 - CORRECT
ANSWER✅✅✅cGMPs include guidelines in ICHE6
What is not a benefit in external market that comes with ISO certification?
ISO certification leads to decreased advantage over a competing product
ISO certification can lead to increased market share
ISO certification can lead to less need for purchasers to perform quality audits
ISO certification leads to perception of higher product quality by consumers
ISO certification can reduce the time needed to market a product - CORRECT ANSWER✅✅✅ISO
certification leads to decreased advantage over a competing product
