BTEC 3320 Exam 1 70 QUESTIONS AND CORRECT
ANSWERS LATEST GRADED A+
The part of quality risk management that involves figuring out which steps might lead the product to
not meet specifications is:
Risk evaluation
Risk identification
Risk reduction
Risk acceptance
Review of risk events - ANSWER-Risk identification
What is true of risk scores?
"Companies are usually unable to reduce the severity score for a given process, but can take steps to
reduce likelihood of failure."
The numerical value of the risk score is the most important value in risk analysis
Two separate companies manufacturing the same drug would typically have identical risk scores for
the same manufacturing activities
"The actual risk score mean the same to a company, regulators, and other companies as well"
The ultimate goal of risk scores is to rank the risks so one can prioritize what needs to be presented
to FDA inspectors - ANSWER-"Companies are usually unable to reduce the severity score for a
given process, but can take steps to reduce likelihood of failure."
"Choose the best answer. In the cause-and-effect matrix shown in the projector, the risks that the
microbial counts might exceed specifications is lowest during which stage in the antibody
manufacturing process?"
Chromatographic purification
Viral filtration
Concentration
Fermentation and harvest
Diafiltration - ANSWER-Fermentation and harvest
Quality risk management for drug manufacturing is covered in the FDA's guidance on Pharmaceutical
cGMPs for the 21st Century and in _______.
,ICHQ9
ICHQ8
ICHQ7
ICHQ10
ICHQ6 - ANSWER-ICHQ9
"Pareto principle that by addressing ______ % of the possible sources of failures, a company may
avoid be able to avoid _______% of any problem."
"40,60"
"20,80"
"50,50"
"80, 20"
"60, 40" - ANSWER-"20,80"
Choose the best answer. Actions taken to reduce or minimize risks is referred to as:
Risk delimitation
Risk quantification
Risk minimization
Risk mitigation
Risk devaluation - ANSWER-Risk minimization
"The part of quality risk management that involves assigning risk values to severity, likellihood and
detectability is:"
Risk acceptance
Review of risk events
Risk reduction
Risk identification
Risk analysis - ANSWER-Risk analysis
, "In a risk analysis score where the scale for each of the 3 components of risk analysis ranges from 1
to 3, for any given activity, process, material or equipment where failure would result to rejection of
the drug product, FDA should shut down a drug manufacturer that is aiming for a risk score of:"
21
3
6
9
27 - ANSWER-27
"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."
electronic documentation
corrective actions
thorough investigations
risk management
validation approaches - ANSWER-risk management
"To quantify the risk priority, numbers are assigned to severity, likelihood, and detectability. Which
statement does not apply to those three components?"
Likelihood is an estimate that a failure might occur
Severity is a measure of the impact of product failure to a patient's health
Detectability is an estimate on whether the failure could be caught after it happens
Detectability can be increased by using more intelligent or advance equipment for a given process
Severity is a measure of the impact of product failure to a company's annual revenue - ANSWER-
Detectability is an estimate on whether the failure could be caught after it happens
The process which involves stating product requirements then assessing ways by which the product
might fail to meet the requirements is also known as FMEA which stands for?
Federal Emergency Management Agency
Failure Mode and Effects Analysis
Failure Maintenance and Effective Analysis
Federal Management of Emergency Aid
ANSWERS LATEST GRADED A+
The part of quality risk management that involves figuring out which steps might lead the product to
not meet specifications is:
Risk evaluation
Risk identification
Risk reduction
Risk acceptance
Review of risk events - ANSWER-Risk identification
What is true of risk scores?
"Companies are usually unable to reduce the severity score for a given process, but can take steps to
reduce likelihood of failure."
The numerical value of the risk score is the most important value in risk analysis
Two separate companies manufacturing the same drug would typically have identical risk scores for
the same manufacturing activities
"The actual risk score mean the same to a company, regulators, and other companies as well"
The ultimate goal of risk scores is to rank the risks so one can prioritize what needs to be presented
to FDA inspectors - ANSWER-"Companies are usually unable to reduce the severity score for a
given process, but can take steps to reduce likelihood of failure."
"Choose the best answer. In the cause-and-effect matrix shown in the projector, the risks that the
microbial counts might exceed specifications is lowest during which stage in the antibody
manufacturing process?"
Chromatographic purification
Viral filtration
Concentration
Fermentation and harvest
Diafiltration - ANSWER-Fermentation and harvest
Quality risk management for drug manufacturing is covered in the FDA's guidance on Pharmaceutical
cGMPs for the 21st Century and in _______.
,ICHQ9
ICHQ8
ICHQ7
ICHQ10
ICHQ6 - ANSWER-ICHQ9
"Pareto principle that by addressing ______ % of the possible sources of failures, a company may
avoid be able to avoid _______% of any problem."
"40,60"
"20,80"
"50,50"
"80, 20"
"60, 40" - ANSWER-"20,80"
Choose the best answer. Actions taken to reduce or minimize risks is referred to as:
Risk delimitation
Risk quantification
Risk minimization
Risk mitigation
Risk devaluation - ANSWER-Risk minimization
"The part of quality risk management that involves assigning risk values to severity, likellihood and
detectability is:"
Risk acceptance
Review of risk events
Risk reduction
Risk identification
Risk analysis - ANSWER-Risk analysis
, "In a risk analysis score where the scale for each of the 3 components of risk analysis ranges from 1
to 3, for any given activity, process, material or equipment where failure would result to rejection of
the drug product, FDA should shut down a drug manufacturer that is aiming for a risk score of:"
21
3
6
9
27 - ANSWER-27
"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."
electronic documentation
corrective actions
thorough investigations
risk management
validation approaches - ANSWER-risk management
"To quantify the risk priority, numbers are assigned to severity, likelihood, and detectability. Which
statement does not apply to those three components?"
Likelihood is an estimate that a failure might occur
Severity is a measure of the impact of product failure to a patient's health
Detectability is an estimate on whether the failure could be caught after it happens
Detectability can be increased by using more intelligent or advance equipment for a given process
Severity is a measure of the impact of product failure to a company's annual revenue - ANSWER-
Detectability is an estimate on whether the failure could be caught after it happens
The process which involves stating product requirements then assessing ways by which the product
might fail to meet the requirements is also known as FMEA which stands for?
Federal Emergency Management Agency
Failure Mode and Effects Analysis
Failure Maintenance and Effective Analysis
Federal Management of Emergency Aid
