BTEC 3320 EXAM 1
QUESTIONS &
ANSWERS (SOLVED)
100% CORRECT!!
BTEC 3320
Evatee 9/29/24 BTEC 3320
,BTEC 3320 EXAM 1 QUESTIONS & ANSWERS
(SOLVED) 100% CORRECT!!
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 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 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 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 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"
Answer - standardize the technical requirements for the registration of
pharmaceuticals
QUESTIONS &
ANSWERS (SOLVED)
100% CORRECT!!
BTEC 3320
Evatee 9/29/24 BTEC 3320
,BTEC 3320 EXAM 1 QUESTIONS & ANSWERS
(SOLVED) 100% CORRECT!!
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 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 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 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 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"
Answer - standardize the technical requirements for the registration of
pharmaceuticals
