MY FINAL EXAM
CARDS BTEC 3320
QUESTIONS WITH
100% CORRECT
SOLUTIONS!!
BTEC 3320
Evatee 9/29/24 BTEC 3320
,MY FINAL EXAM CARDS BTEC 3320
QUESTIONS WITH 100% CORRECT
SOLUTIONS!!
What is not true of cGMPs?
cGMPs include guidelines in ICHQ7A
cGMPs includes Acts passed by the FDA
cGMPS require compliance with regulations as in CFR21 Part 211
cGMPs apply to drugs and devices
cGMPs apply to both marketed and investigational drugs Answer - cGMPs
includes Acts passed by the FDA
What applies to ISO9000 but not to GMP regulations?
Compliance to ISO9000 standards is required by law
ISO9000 regulations are specific to the pharma or medical industry
,Quality manual is not required
Compliance is monitored by a paid auditor who provides suggestions for
improvement
Originated in the United States Answer - Compliance is monitored by a paid
auditor who provides suggestions for improvement
The use of the term "current Good Manufacturing Practice" first became
prevalent in the:
"Federal Food, Drug and Cosmetic Act of 1938"
Biologics Control Act of 1902
Sherley Amendment of 1912
Kefauver-Harris Amendments of 1962
Pure Foods and Drug Act of 1906 Answer - Kefauver-Harris Amendments of
1962
"According to the International Organization for Standardization (ISO) website a
standard is a _______________ 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." Answer -
Document
, What is not a major benefit in internal operations that comes with a company
being ISO certified?
enhanced inter-company communications
Improved documentation
greater operational efficiency & productivity
increased scrap and rework expenses
greater quality awareness by employees Answer - increased scrap and rework
expenses
(ISO certification should REDUCE expenses)
"What quality attribute was added as a requirement for drugs prior to
marketing in the Kefauver-Harris Amendments of 1962, but not in the Food
Drug and Cosmetic Act of 1938?"
Fitness
Safety
Purity
Strength
Efficacy Answer - Efficacy
CARDS BTEC 3320
QUESTIONS WITH
100% CORRECT
SOLUTIONS!!
BTEC 3320
Evatee 9/29/24 BTEC 3320
,MY FINAL EXAM CARDS BTEC 3320
QUESTIONS WITH 100% CORRECT
SOLUTIONS!!
What is not true of cGMPs?
cGMPs include guidelines in ICHQ7A
cGMPs includes Acts passed by the FDA
cGMPS require compliance with regulations as in CFR21 Part 211
cGMPs apply to drugs and devices
cGMPs apply to both marketed and investigational drugs Answer - cGMPs
includes Acts passed by the FDA
What applies to ISO9000 but not to GMP regulations?
Compliance to ISO9000 standards is required by law
ISO9000 regulations are specific to the pharma or medical industry
,Quality manual is not required
Compliance is monitored by a paid auditor who provides suggestions for
improvement
Originated in the United States Answer - Compliance is monitored by a paid
auditor who provides suggestions for improvement
The use of the term "current Good Manufacturing Practice" first became
prevalent in the:
"Federal Food, Drug and Cosmetic Act of 1938"
Biologics Control Act of 1902
Sherley Amendment of 1912
Kefauver-Harris Amendments of 1962
Pure Foods and Drug Act of 1906 Answer - Kefauver-Harris Amendments of
1962
"According to the International Organization for Standardization (ISO) website a
standard is a _______________ 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." Answer -
Document
, What is not a major benefit in internal operations that comes with a company
being ISO certified?
enhanced inter-company communications
Improved documentation
greater operational efficiency & productivity
increased scrap and rework expenses
greater quality awareness by employees Answer - increased scrap and rework
expenses
(ISO certification should REDUCE expenses)
"What quality attribute was added as a requirement for drugs prior to
marketing in the Kefauver-Harris Amendments of 1962, but not in the Food
Drug and Cosmetic Act of 1938?"
Fitness
Safety
Purity
Strength
Efficacy Answer - Efficacy
