CQM-C(CLINICAL QUALITY MEASURES) Exam Newest
2025/2026 Complete All Questions And Correct Detailed
Answers (Verified Answers) |Already Graded
A+||Brand New Version!!
The quality system elements and management responsibilities described in _____
are intended to encourage the use of science- and risk-based approaches at each
lifecycle stage, thereby promoting continual improvement across the entire
product lifecycle.
21 CFR Part 211
The Federal Food, Drug, and Cosmetic Act
ICH Q7A
21 CFR Part 600
ICH Q10 - CORRECT ANSWER-ICH Q10
FDA equivalent agency in the UK
COFEPRIS
MHRA
ANVISA
PMDA
CDSCO - CORRECT ANSWER-MHRA
What type of quality attribute is especially important for multi-product facilities?
strength
stability
,purity
identity
potency - CORRECT ANSWER-identity
______ is an expression of the activity of a drug in terms of the concentration or
amount of the drug required to produce a defined effect.
Potency
Strength
Efficacy
Stability
Consistency - CORRECT ANSWER-Potency
With the Pharmaceutical CGMPs for the 21st Century guidance, FDA announced
its desire for manufacturers to integrate quality systems and
_____________________ approaches into its existing programs.
thorough investigations
validation approaches
risk management
corrective actions
electronic documentation - CORRECT ANSWER-risk management
What is a type of impurity?
product
chemical
all are correct
,biological
process - CORRECT ANSWER-all are correct
Consistency of product quality is achieved by adherence to four on-going
processes. Which is not one of the four?
validation
testing
continuous improvement
documentation
protocol deviations - CORRECT ANSWER-protocol deviations
Tests performed by quality control should be against _____________________ to
objectively show that the material is acceptable or should be rejected.
pre-determined expectations
pre-determined specifications
verbally-communicated specifications
confidential specifications
flexible specifications - CORRECT ANSWER-pre-determined specifications
What is one activity performed under the pharmaceutical development phase of
the product lifecycle (per ICHQ10)?
manufacture of investigational products
commercial manufacturing
new product transfers during development through manufacturing
retention of documentation
, sample retention - CORRECT ANSWER-manufacture of investigational products
What is a responsibility of the quality control group?
ensures all GMP operations are compliant with CGMP regulations
developing, validating and performing assays
approval of procedures
internal auditing
approval of products - CORRECT ANSWER-developing, validating and performing
assays
Quality should be ____ into the product, and ______ alone cannot be relied on to
ensure product quality.
built, testing
tested, documentation
tested, safety
built, safety
tested, efficacy - CORRECT ANSWER-built, testing
Designing and developing a product and associated manufacturing processes that
will be used during product development to ensure the product consistently
attains a predefined quality at the end of the manufacturing process is known as
what?
risk management
pharmaceutical development
technology transfer
quality by design
2025/2026 Complete All Questions And Correct Detailed
Answers (Verified Answers) |Already Graded
A+||Brand New Version!!
The quality system elements and management responsibilities described in _____
are intended to encourage the use of science- and risk-based approaches at each
lifecycle stage, thereby promoting continual improvement across the entire
product lifecycle.
21 CFR Part 211
The Federal Food, Drug, and Cosmetic Act
ICH Q7A
21 CFR Part 600
ICH Q10 - CORRECT ANSWER-ICH Q10
FDA equivalent agency in the UK
COFEPRIS
MHRA
ANVISA
PMDA
CDSCO - CORRECT ANSWER-MHRA
What type of quality attribute is especially important for multi-product facilities?
strength
stability
,purity
identity
potency - CORRECT ANSWER-identity
______ is an expression of the activity of a drug in terms of the concentration or
amount of the drug required to produce a defined effect.
Potency
Strength
Efficacy
Stability
Consistency - CORRECT ANSWER-Potency
With the Pharmaceutical CGMPs for the 21st Century guidance, FDA announced
its desire for manufacturers to integrate quality systems and
_____________________ approaches into its existing programs.
thorough investigations
validation approaches
risk management
corrective actions
electronic documentation - CORRECT ANSWER-risk management
What is a type of impurity?
product
chemical
all are correct
,biological
process - CORRECT ANSWER-all are correct
Consistency of product quality is achieved by adherence to four on-going
processes. Which is not one of the four?
validation
testing
continuous improvement
documentation
protocol deviations - CORRECT ANSWER-protocol deviations
Tests performed by quality control should be against _____________________ to
objectively show that the material is acceptable or should be rejected.
pre-determined expectations
pre-determined specifications
verbally-communicated specifications
confidential specifications
flexible specifications - CORRECT ANSWER-pre-determined specifications
What is one activity performed under the pharmaceutical development phase of
the product lifecycle (per ICHQ10)?
manufacture of investigational products
commercial manufacturing
new product transfers during development through manufacturing
retention of documentation
, sample retention - CORRECT ANSWER-manufacture of investigational products
What is a responsibility of the quality control group?
ensures all GMP operations are compliant with CGMP regulations
developing, validating and performing assays
approval of procedures
internal auditing
approval of products - CORRECT ANSWER-developing, validating and performing
assays
Quality should be ____ into the product, and ______ alone cannot be relied on to
ensure product quality.
built, testing
tested, documentation
tested, safety
built, safety
tested, efficacy - CORRECT ANSWER-built, testing
Designing and developing a product and associated manufacturing processes that
will be used during product development to ensure the product consistently
attains a predefined quality at the end of the manufacturing process is known as
what?
risk management
pharmaceutical development
technology transfer
quality by design
