BTEC 3320 EXAM 2 QUESTIONS AND
ANSWERS 2026 COMPREHENSIVE EXAM
◉ "In the sampling table shown, for a lot size of 2500, if the number
of defects are __________ or more units, then the batch should be
rejected."
5 units
15 units
10 units
8 units
11 units. Answer: 8 units
◉ What is not always a requirement for cGMP-compliant sampling?
Samples obtained must be properly identified and handled
Samples must be an accurate representatiion of the material or drug
product batch
Sampling plans must be based on appropriate statistical criteria
>50% of a drug product lot should be tested
"Sampling plans and methods must be written, defined, and pre-
approved". Answer: >50% of a drug product lot should be tested
,◉ "In the Genzyme video, it states that the typical biotherapeutic
protein production process using mammalian cells as production
host lasts:"
around 6 months
1 year
around 3 months
around a month
half a month. Answer: around 3 months
◉ What is not a product release test for biologics?
amino acid sequencing of biologic
mg antibody per vial of drug product
tests for potency
test for endotoxins
sequence of recombinant gene in production host. Answer: sequence
of recombinant gene in production host
◉ What is not considered as in-process tests for typical coated
tablets?
, Tablet capping
Fill accuracy
Blend uniformity
Water content
Particle size distribution. Answer: Fill accuracy
◉ It is acceptable for QA to periodically monitor the end product in
place of working to prevent contamination.
FALSE
TRUE. Answer: FALSE
◉ Analytical tests are performed on:
Stability samples
All are correct
Active pharmaceutical ingredients
In-process materials
Final drug products
Raw materials. Answer: All are correct
ANSWERS 2026 COMPREHENSIVE EXAM
◉ "In the sampling table shown, for a lot size of 2500, if the number
of defects are __________ or more units, then the batch should be
rejected."
5 units
15 units
10 units
8 units
11 units. Answer: 8 units
◉ What is not always a requirement for cGMP-compliant sampling?
Samples obtained must be properly identified and handled
Samples must be an accurate representatiion of the material or drug
product batch
Sampling plans must be based on appropriate statistical criteria
>50% of a drug product lot should be tested
"Sampling plans and methods must be written, defined, and pre-
approved". Answer: >50% of a drug product lot should be tested
,◉ "In the Genzyme video, it states that the typical biotherapeutic
protein production process using mammalian cells as production
host lasts:"
around 6 months
1 year
around 3 months
around a month
half a month. Answer: around 3 months
◉ What is not a product release test for biologics?
amino acid sequencing of biologic
mg antibody per vial of drug product
tests for potency
test for endotoxins
sequence of recombinant gene in production host. Answer: sequence
of recombinant gene in production host
◉ What is not considered as in-process tests for typical coated
tablets?
, Tablet capping
Fill accuracy
Blend uniformity
Water content
Particle size distribution. Answer: Fill accuracy
◉ It is acceptable for QA to periodically monitor the end product in
place of working to prevent contamination.
FALSE
TRUE. Answer: FALSE
◉ Analytical tests are performed on:
Stability samples
All are correct
Active pharmaceutical ingredients
In-process materials
Final drug products
Raw materials. Answer: All are correct
