BTEC 3320 Exam 100 questions AND
CORRECT DETAILED ANSWERS//GRADED A+
"In method validation, say for a PCR, which method attribute pertains to the lowest amount of DNA
in a given sample that can be measured accurately?"
a) Consistency
b) Limit of quantitation
c) Specificity
d) Accuracy
e) Reproducibility - ANSWER-b) Limit of quantitation
"In method validation, which method attribute pertains to the ability to obtain instrument readings,
say absorbance, which are directly proportional to the concentration (amount) of analyte in the
sample. "
a) Specificity
b) Linearity
c) Reproducibility
d) Sensitivity
e) Consistency - ANSWER-b) Linearity
Sensitivity in method validation:
a) is the ability of the method to detect and measure the API separately from other chemically-
related or unrelated substances in the drug product
b) "Is the ability of a method to give consistent results when ran at slightly different run conditions,
pH, or temperature."
c) "pertains to the ability of the method to give values that are very close together, but not
necessarily close to the true value"
d) pertains to the ability of the method to detect very low levels of an impurity in a drug product
e) pertains to the ability of the method to give the true value of an API in a drug product -
ANSWER-d) pertains to the ability of the method to detect very low levels of an impurity in a drug
product
The Cutter Incident led to regulations on the need for process validation. What is not related to the
Cutter Incident?
a) Autoclaving process change
,b) Virus inactivation
c) Formaldehyde
d) Unsafe polio vaccine
e) Paralysis - ANSWER-a) Autoclaving process change
"When manufacturing of the the anti-inflammatory drug, Remicade, was transferred from the
Netherlands site to Pennsylvania and scaled up, what was the unanticipated consequence of
processing the resulting increased product yield which led to a need to revalidate processes?"
a) The column gets clogged more easily and need constant cleaning and replacement
b) A significant portion of the product do not bind to the chromatography column and just goes
through the column
c) There is increased clogging of the bioreactor spin filters in the continuous cultures
d) A great portion of the product produces protein aggregates in the column
e) The product binds tightly to the chromatography column and are not washed out of the column -
ANSWER-b) A significant portion of the product do not bind to the chromatography column and
just goes through the column
Validation is expensive. What is not a way by which validation saves the company money in the long
run?
a) Improved process consistency eliminates the need for raw material testing
b) Fewer product complaints that need to be addressed or investigated and less product returns or
recalls
c) Increased throughput or productivity due to a reduction in rejects and reworks
d) Improved process efficiency means lower utility and raw material costs
e) Better product quality can translate to enhanced customer preference and market share -
ANSWER-a) Improved process consistency eliminates the need for raw material testing
"Being a zealous manufacturing supervisor, you noticed that your autoclave loading plan leaves room
for additional material which can be loaded. Realizing that increasing that amount of material in the
autoclave will shorten the turn around time for the production line you considered increasing the
amount of material loaded into the autoclave than specified by the loading plan. Despite the change
in loading amount, design and installation qualification will not need to be redone."
a) TRUE
b) FALSE - ANSWER-a) TRUE
, Which of the steps in equipment qualification is where it is determined first whether the detector is
able to produce a signal when reference standards are injected in an HPLC or a protein
chromatography set up?
a) Operational qualification
b) Installation qualification
c) Design qualification
d) Process qualifications
e) Performance qualification - ANSWER-a) Operational qualification
What will not need to be established in the process validation for production of a biologic drug?
a) Virus removal
b) Cell transformation efficiency
c) Holding of the supernatant or filtrate
d) Endotoxin control
e) Removal of host cell proteins - ANSWER-b) Cell transformation efficiency
"In the FDA's quality system inspection technique, for a company that has a track record of
compliance with FDA regulations, the FDA inspects:"
a) The quality system + 5 other systems
b) The production system alone is sufficient
c) The quality system + at least 3 other systems
d) The quality system alone is sufficient
e) The quality system + at least 1 other system - ANSWER-e) The quality system + at least 1 other
system
"In QA's internal audit of manufacturing companies, some classify deficiencies as critical, major, and
minor. What is a disadvantage of such ranking system?"
a) Rankings can be subjective depending on the auditors who do the audit
b) Rankings don't help the auditee in prioritizing the areas to correct
c) Auditors are not able to point out areas of concern that may not have caught management's
attention
d) FDA inspectors don't really care about the rankings
CORRECT DETAILED ANSWERS//GRADED A+
"In method validation, say for a PCR, which method attribute pertains to the lowest amount of DNA
in a given sample that can be measured accurately?"
a) Consistency
b) Limit of quantitation
c) Specificity
d) Accuracy
e) Reproducibility - ANSWER-b) Limit of quantitation
"In method validation, which method attribute pertains to the ability to obtain instrument readings,
say absorbance, which are directly proportional to the concentration (amount) of analyte in the
sample. "
a) Specificity
b) Linearity
c) Reproducibility
d) Sensitivity
e) Consistency - ANSWER-b) Linearity
Sensitivity in method validation:
a) is the ability of the method to detect and measure the API separately from other chemically-
related or unrelated substances in the drug product
b) "Is the ability of a method to give consistent results when ran at slightly different run conditions,
pH, or temperature."
c) "pertains to the ability of the method to give values that are very close together, but not
necessarily close to the true value"
d) pertains to the ability of the method to detect very low levels of an impurity in a drug product
e) pertains to the ability of the method to give the true value of an API in a drug product -
ANSWER-d) pertains to the ability of the method to detect very low levels of an impurity in a drug
product
The Cutter Incident led to regulations on the need for process validation. What is not related to the
Cutter Incident?
a) Autoclaving process change
,b) Virus inactivation
c) Formaldehyde
d) Unsafe polio vaccine
e) Paralysis - ANSWER-a) Autoclaving process change
"When manufacturing of the the anti-inflammatory drug, Remicade, was transferred from the
Netherlands site to Pennsylvania and scaled up, what was the unanticipated consequence of
processing the resulting increased product yield which led to a need to revalidate processes?"
a) The column gets clogged more easily and need constant cleaning and replacement
b) A significant portion of the product do not bind to the chromatography column and just goes
through the column
c) There is increased clogging of the bioreactor spin filters in the continuous cultures
d) A great portion of the product produces protein aggregates in the column
e) The product binds tightly to the chromatography column and are not washed out of the column -
ANSWER-b) A significant portion of the product do not bind to the chromatography column and
just goes through the column
Validation is expensive. What is not a way by which validation saves the company money in the long
run?
a) Improved process consistency eliminates the need for raw material testing
b) Fewer product complaints that need to be addressed or investigated and less product returns or
recalls
c) Increased throughput or productivity due to a reduction in rejects and reworks
d) Improved process efficiency means lower utility and raw material costs
e) Better product quality can translate to enhanced customer preference and market share -
ANSWER-a) Improved process consistency eliminates the need for raw material testing
"Being a zealous manufacturing supervisor, you noticed that your autoclave loading plan leaves room
for additional material which can be loaded. Realizing that increasing that amount of material in the
autoclave will shorten the turn around time for the production line you considered increasing the
amount of material loaded into the autoclave than specified by the loading plan. Despite the change
in loading amount, design and installation qualification will not need to be redone."
a) TRUE
b) FALSE - ANSWER-a) TRUE
, Which of the steps in equipment qualification is where it is determined first whether the detector is
able to produce a signal when reference standards are injected in an HPLC or a protein
chromatography set up?
a) Operational qualification
b) Installation qualification
c) Design qualification
d) Process qualifications
e) Performance qualification - ANSWER-a) Operational qualification
What will not need to be established in the process validation for production of a biologic drug?
a) Virus removal
b) Cell transformation efficiency
c) Holding of the supernatant or filtrate
d) Endotoxin control
e) Removal of host cell proteins - ANSWER-b) Cell transformation efficiency
"In the FDA's quality system inspection technique, for a company that has a track record of
compliance with FDA regulations, the FDA inspects:"
a) The quality system + 5 other systems
b) The production system alone is sufficient
c) The quality system + at least 3 other systems
d) The quality system alone is sufficient
e) The quality system + at least 1 other system - ANSWER-e) The quality system + at least 1 other
system
"In QA's internal audit of manufacturing companies, some classify deficiencies as critical, major, and
minor. What is a disadvantage of such ranking system?"
a) Rankings can be subjective depending on the auditors who do the audit
b) Rankings don't help the auditee in prioritizing the areas to correct
c) Auditors are not able to point out areas of concern that may not have caught management's
attention
d) FDA inspectors don't really care about the rankings
