What does not apply to product creep?
a. Creep can lead to a product that will fail to meet the expectation of regulators
b. Creep can lead to a product
... [Show More] that no longer meets quality expectations
c. Creep leads to product that is safer and more efficacious
d. Creep can involve big changes to the process that leads to small changes in the product
e. Creep can involve small changes to the process that leads to insignificant changes in the
product - CORRECT ANSWER c. Creep leads to product that is safer and more efficacious
"Change control system is in place to balance the need to be progressive, but to also ensure that
the change does not negatively impact product quality. CFR21 part 314 contains regulatory
requirements on the need to inform the FDA of changes in the manufacturing process that is
described in the approved _____________________________ for the drug product."
a. New Drug Application
b. Investigational New Drug Application
c. Active Pharmaceutical Ingredient Summary
d. Pre-clinical approval
e. Establishment Inspection Report - CORRECT ANSWER a. New Drug Application
"According to the figure, the level of effort and formality of change management is least when
manufacturing a drug product that will be used for:"
a. Pre-clinical animal test studies
b. Phase I human trials
c. Commercial distribution
d. Phase III clinical trials
e. Technology transfer from small to commercial scale manufacturing
f. Phase II clinical trials in humans - CORRECT ANSWER a. Pre-clinical animal test studies
What is the correct sequence of steps in the change control process?
a. 1. Originator drafts the proposed change. 2. A document number is assigned by the QA. 3.
Circulated for review. 4. Approved and signed by QA. 5. Effective date is assigned. 6.
Distributed to users. 7. Users are trained. 8. The document becomes effective
b. 1. Originator drafts the proposed change. 2. A document number is assigned by the QA. 3.
Circulated for review. 4. Approved and signed by QA. 5. Distributed to users. 6. Users are
trained. 7. Effective date is assigned. 8. The document becomes effective
c. 1. Originator drafts the proposed change. 2. A document number is assigned by the QA. 3.
Approved and signed by QA. 4. Circulated for review. 5. Effective date is assigned. 6.
Distributed to users. 7. Users are trained. 8. The document becomes effective
d. 1. Originator drafts the proposed change. 2. Circulated for review. 3. A document number is
assigned by the QA. 4. Approved and signed by QA. 5. Effective date is assigned. 6. Distributed
to users. 7. Users are trained. 8. The document becomes effective
e. 1. Originator drafts the proposed change. 2. A document number is assigned by the QA. 3.
Circulated for review. 4. Approved and signed by QA. 5. Effective date is assigned. 6.
Distributed to users. 7. The document becomes effective. 8. Users are trained - CORRECT
ANSWER a. 1. Originator drafts the proposed change. 2. A document number is assigned by the
QA. 3. Circulated for review. 4. Approved and signed by QA. 5. Effective date is assigned. 6.
Distributed to users. 7. Users are trained. 8. The document becomes effective
Which of these changes would require a description of the change to be included in the annual
report that a company submits to the FDA?
a. All will need to be included in the annual report
b. CBE-30
c. CBE-0
d. Minor change
e. Major change - CORRECT ANSWER a. All will need to be included in the annual report
"Huahai was cited for not performing necessary risk assessment prior to a change in their
validated API manufacturing process that led to the presence of a genotoxic impurity. As part of
an attempt on continuous improvement of a validated manufacturing process, a new method is
developed and tested first at small lab scale, then tested at _________ scale batches, prior to
validation of the final commercial scale process."
a. weighing
b. 96-well scale
c. pilot
d. test tube
e. fish
f. reduced - CORRECT ANSWER c. pilot
What is not true of change control as it applies to documentation?
a. All the other choices are true of documentation change control
b. Change control is used for making changes to existing documents or SOPs.
c. Change control is used for creating a new SOP
d. Change control is used for retiring SOPs that will no longer be put to use - CORRECT
ANSWER a. All the other choices are true of documentation change control
In change classified as CBE-0:
a. The manufacturer has to give FDA 30-days to approve the change before marketing the
"changed" drug product
b. CBE-0 means there are zero changes in the process used to manufacture a new lot of drug
c. The "changed" drug product can be marketed once FDA receives the change request
d. The "changed" drug product lot can be marketed without informing the FDA
e. The "changed" drug product can be marketed once the manufacturer receives 0 (zero) response
from the FDA - CORRECT ANSWER c. The "changed" drug product can be marketed once
FDA receives the change request
"Risk assessment is part of the change review process. A main consideration on deciding the
significance of the change is, or should be:"
a. The effect on product safety
b. The effect on wasted raw materials
c. The effect on long work hours
d. The effect on company profit
e. The effect on product market share - CORRECT ANSWER a. The effect on product safety
Search for the FDA guidance on Changes to an Approved Application for Biological Products.
Which of these changes would most likely be classified as minor change?
a. A change in the stability test protocol to a narrower or tighter range in passing specifications
b. Moving to a different manufacturing site
Using a different excipient or buffer for the formulation of the drug product
c. Changing the drug product storage temperature from what is documented in a BLA
d. Using a new type of column for product purification
e. Prolonging culture growth time leading to significant increase in number of cellsper ml which
is beyond validated parameters. - CORRECT ANSWER a. A change in the stability test protocol
to a narrower or tighter range in passing specifications
What is not part of the change control process?
a. The draft of the revised document is circulated for review
b. Older SOPs are surrendered to QA group
c. Users are trained prior to the document becoming effective
d. A master copy of the approved document is retained within the marketing group
e. Older SOPs are rendered obsolete - CORRECT ANSWER d. A master copy of the approved
document is retained within the marketing group
The intent of change control system is to determine the need for actions that would ensure that
the system is maintained in a ________________ state.
a. Advance
b. Risk-free
c. Balanced
d. Innovative
e. Validated
f. Modern - CORRECT ANSWER e. Validated
Quiz 7
"In a type of sampling risk classified as producer's risk, the manufacturer will risk losing money
because:"
a. "Lot is good, but rejected and not released for marketing"
b. Consumer's health is put at risk
c. Lot is good and accepted
d. Lot is bad and reprocessed
e. Lot is bad and rejected
f. "Lot is bad, but accepted and released for marketing" - CORRECT ANSWER a. "Lot is good,
but rejected and not released for marketing"
What is not a process control variable in the downstream purification process?
a. Filtration temperature
b. Presence of cleaning reagents in the bioreactor
c. Filtration backpressure
d. pH of chromatography mobile phase
e. Centrifugation speed - CORRECT ANSWER b. Presence of cleaning reagents in the
bioreactor
"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. Military standard
d. American Society for Quality
e. International Organization for Standardization - CORRECT ANSWER a. American Institute
for Sampling Compliance [Show Less]