BTEC 3320 Exam 3 Quizzes 6-13
2024/2025 Exam Questions with Detailed
Verified Answers (100% Correct
Answers) | Already Graded A+
"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 - 🧠ANSWER ✔✔a) 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
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,d) Release specifications are approved by regulatory agency as conditions
for marketing approval
e) Specifications include rejection criteria for certain attributes - 🧠ANSWER
✔✔a) 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" -
🧠ANSWER ✔✔a) "Thaw frozen cell bank, small-scale growth, large-scale
growth, harvesting, filtration, chromatographic purification, fill and finish"
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STATEMENT. ALL RIGHTS RESERVED
,"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 - 🧠ANSWER ✔✔a) 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 - 🧠ANSWER
✔✔a) 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
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY 3
STATEMENT. ALL RIGHTS RESERVED
, c) microbes
d) endotoxins
e) dust particles
f) An inorganic catalyst - 🧠ANSWER ✔✔a) 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 - 🧠ANSWER
✔✔a) 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
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY 4
STATEMENT. ALL RIGHTS RESERVED
2024/2025 Exam Questions with Detailed
Verified Answers (100% Correct
Answers) | Already Graded A+
"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 - 🧠ANSWER ✔✔a) 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
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY 1
STATEMENT. ALL RIGHTS RESERVED
,d) Release specifications are approved by regulatory agency as conditions
for marketing approval
e) Specifications include rejection criteria for certain attributes - 🧠ANSWER
✔✔a) 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" -
🧠ANSWER ✔✔a) "Thaw frozen cell bank, small-scale growth, large-scale
growth, harvesting, filtration, chromatographic purification, fill and finish"
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY 2
STATEMENT. ALL RIGHTS RESERVED
,"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 - 🧠ANSWER ✔✔a) 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 - 🧠ANSWER
✔✔a) 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
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY 3
STATEMENT. ALL RIGHTS RESERVED
, c) microbes
d) endotoxins
e) dust particles
f) An inorganic catalyst - 🧠ANSWER ✔✔a) 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 - 🧠ANSWER
✔✔a) 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
COPYRIGHT©NINJANERD 2025/2026. YEAR PUBLISHED 2025. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE. PRIVACY 4
STATEMENT. ALL RIGHTS RESERVED
