BTEC 3320 Exam 3 Questions &
Answers 2024/2025
"During bioprocess, the temperature sensors (probes) are dipped in the fermentation culture inside the
bioreactor, signal from the sensors read by a computer, and the temperature of the heating blanket gets
automatically adjusted. The temperature measurement by the sensor is an example of:"
a) In-line measurement
b) Non-invasive measurement
c) On-line measurement
d) At-line measurement
e) Out-of-line measurement - ANSWERSa) In-line measurement
What does not apply to specifications for release of finish drug products?
a) Acceptance criteria should be changed if test results don't conform to specifications
b) Many analytical procedures that are part of specifications are found in the US Pharmacopeia
c) Specifications consist of test procedures
d) Release specifications are approved by regulatory agency as conditions for marketing approval
e) Specifications include rejection criteria for certain attributes - ANSWERSa) Acceptance criteria should
be changed if test results don't conform to specifications
"In the Genzyme video on producing biotherapeutics using mammalian cells, what is the correct
sequence of manufacturing activities in the 90-day production flow?"
a) "Thaw frozen cell bank, small-scale growth, large-scale growth, harvesting, filtration, chromatographic
purification, fill and finish"
b) "Thaw frozen cell bank, large-scale growth, small-scale growth, production, harvest, filtration,
chromatographic purification, fill and finish"
c) "Thaw frozen cell bank, small-scale growth, large-scale growth, fill and finish, harvest, filtration,
chromatographic purification"
d) "Thaw frozen cell bank, small-scale growth, large-scale growth, chromatographic purification, harvest,
fill and finish"
,e) "Small-scale growth, large-scale growth, production, harvest, chromatographic purification, fill and
finish, thaw frozen cell bank" - ANSWERSa) "Thaw frozen cell bank, small-scale growth, large-scale
growth, harvesting, filtration, chromatographic purification, fill and finish"
"In the sampling table shown in slide 35, for a lot size of 660, ______________ units should be obtained
and tested for conformance to specifications."
a) 32 units
b) 125 units
c) 200 units
d) 315 units
e) 50 units - ANSWERSa) 32 units
What is not a main job responsibility of the QC group?
a) Checking adherence of process technician to batch record SOPs
b) Analytical testing of raw materials against specifications before use by the production group
c) Testing of drug products against specifications before release
c) Provide analytical support for process validation and in-process tests
e) Environmental monitoring for viables and non-viables - ANSWERSa) Checking adherence of process
technician to batch record SOPs
"In the manufacturing of small molecule drugs, what would be considered as an impurity rather than a
contaminant?"
a) incompletely synthesized API
b) equipment lubricants
c) microbes
d) endotoxins
e) dust particles
f) An inorganic catalyst - ANSWERSa) incompletely synthesized API
What is not always a requirement for cGMP-compliant sampling?
, a) Samples must be stored at low temperatures
b) "Sampling plans and methods must be written, defined, and pre-approved"
c) Samples must accurately portray the quality attributes of a drug product lot
d) Sampling plans must be based on appropriate statistical criteria
e) Samples obtained must be properly identified and handled - ANSWERSa) Samples must be stored at
low temperatures
"What is not a source of information on acceptable sampling sizes, like the table shown below?"
a) American Institute for Sampling Compliance
b) American National Standards Institute
c) American Society for Quality
d) Military standard
e) International Organization for Standardization - ANSWERSa) American Institute for Sampling
Compliance
Which is not an in-process control test used to monitor the progress of protein production during
fermentation?
a) Gene copy number
b) Concentration of biologic
c) Presence of misfolded proteins
d) Presence of chemicals used to clean the bioreactor
e) Endotoxin levels - ANSWERSa) Gene copy number
What does not apply to raw materials or raw material testing?
a) Full testing against the CofA should be conducted on all raw materials
b) Criticality of materials and tests differ for different raw materials depending on their intended use
c) "Raw materials must be identified, quarantined, their identity tested by specific assays, and released
by QC and QA"
d) "Quality requirements for raw materials are met somewhat differently in production of pre-clinical,
clinical batches, and manufacturing of licensed products"
Answers 2024/2025
"During bioprocess, the temperature sensors (probes) are dipped in the fermentation culture inside the
bioreactor, signal from the sensors read by a computer, and the temperature of the heating blanket gets
automatically adjusted. The temperature measurement by the sensor is an example of:"
a) In-line measurement
b) Non-invasive measurement
c) On-line measurement
d) At-line measurement
e) Out-of-line measurement - ANSWERSa) In-line measurement
What does not apply to specifications for release of finish drug products?
a) Acceptance criteria should be changed if test results don't conform to specifications
b) Many analytical procedures that are part of specifications are found in the US Pharmacopeia
c) Specifications consist of test procedures
d) Release specifications are approved by regulatory agency as conditions for marketing approval
e) Specifications include rejection criteria for certain attributes - ANSWERSa) Acceptance criteria should
be changed if test results don't conform to specifications
"In the Genzyme video on producing biotherapeutics using mammalian cells, what is the correct
sequence of manufacturing activities in the 90-day production flow?"
a) "Thaw frozen cell bank, small-scale growth, large-scale growth, harvesting, filtration, chromatographic
purification, fill and finish"
b) "Thaw frozen cell bank, large-scale growth, small-scale growth, production, harvest, filtration,
chromatographic purification, fill and finish"
c) "Thaw frozen cell bank, small-scale growth, large-scale growth, fill and finish, harvest, filtration,
chromatographic purification"
d) "Thaw frozen cell bank, small-scale growth, large-scale growth, chromatographic purification, harvest,
fill and finish"
,e) "Small-scale growth, large-scale growth, production, harvest, chromatographic purification, fill and
finish, thaw frozen cell bank" - ANSWERSa) "Thaw frozen cell bank, small-scale growth, large-scale
growth, harvesting, filtration, chromatographic purification, fill and finish"
"In the sampling table shown in slide 35, for a lot size of 660, ______________ units should be obtained
and tested for conformance to specifications."
a) 32 units
b) 125 units
c) 200 units
d) 315 units
e) 50 units - ANSWERSa) 32 units
What is not a main job responsibility of the QC group?
a) Checking adherence of process technician to batch record SOPs
b) Analytical testing of raw materials against specifications before use by the production group
c) Testing of drug products against specifications before release
c) Provide analytical support for process validation and in-process tests
e) Environmental monitoring for viables and non-viables - ANSWERSa) Checking adherence of process
technician to batch record SOPs
"In the manufacturing of small molecule drugs, what would be considered as an impurity rather than a
contaminant?"
a) incompletely synthesized API
b) equipment lubricants
c) microbes
d) endotoxins
e) dust particles
f) An inorganic catalyst - ANSWERSa) incompletely synthesized API
What is not always a requirement for cGMP-compliant sampling?
, a) Samples must be stored at low temperatures
b) "Sampling plans and methods must be written, defined, and pre-approved"
c) Samples must accurately portray the quality attributes of a drug product lot
d) Sampling plans must be based on appropriate statistical criteria
e) Samples obtained must be properly identified and handled - ANSWERSa) Samples must be stored at
low temperatures
"What is not a source of information on acceptable sampling sizes, like the table shown below?"
a) American Institute for Sampling Compliance
b) American National Standards Institute
c) American Society for Quality
d) Military standard
e) International Organization for Standardization - ANSWERSa) American Institute for Sampling
Compliance
Which is not an in-process control test used to monitor the progress of protein production during
fermentation?
a) Gene copy number
b) Concentration of biologic
c) Presence of misfolded proteins
d) Presence of chemicals used to clean the bioreactor
e) Endotoxin levels - ANSWERSa) Gene copy number
What does not apply to raw materials or raw material testing?
a) Full testing against the CofA should be conducted on all raw materials
b) Criticality of materials and tests differ for different raw materials depending on their intended use
c) "Raw materials must be identified, quarantined, their identity tested by specific assays, and released
by QC and QA"
d) "Quality requirements for raw materials are met somewhat differently in production of pre-clinical,
clinical batches, and manufacturing of licensed products"
