BTEC 3320 EXAM 2 QUESTIONS AND
ANSWERS 2026 ACTUAL EXAMINATION TEST
COMPLETE QUESTIONS AND SOLUTIONS
GRADED A+
◉ What is not part of the change control process?
Older SOPs are rendered obsolete
The draft of the revised document is circulated for review
Users are trained prior to the document becoming effective
A master copy of the approved document is retained within the QA
document system
Older SOPs are retained by users. Answer: Older SOPs are retained
by users
◉ A company's change control board is made mainly of members of
the quality assurance and quality control groups
TRUE
FALSE. Answer: FALSE
,◉ The intent of change control system is to determine the need for
actions that would ensure that the system is maintained in a
________________ state.
Innovative
Balanced
Validated
Advance
Modern. Answer: Validated
◉ Small changes to a process can over time can add up and lead to a
product that is no longer what was promised in the New Drug
Application. The result is what is referred to as product ______________.
Creep
Recall
Validation
Failure
Specification
Malfunction. Answer: Creep
, ◉ Some changes would not require approval by the FDA before the
drug product that was manufactured using the changed process can
be distributed.
TRUE
FALSE. Answer: TRUE
◉ What can be a repercussion from an inadequate response to the
violations listed by the FDA to Wockhardt?
Forceful ending of sponsorships and partnerships the firm may have
with similar companies
Reporting only passing test results in laboratory notebooks
Withholding approval of any new applications listing the firm as a
drug product manufacturer
Jail time of a period no less than 5 years for the laboratory manager
and the expulsion of all quality control unit workers
A public media statement by the FDA not recommending the product
to consumers. Answer: Withholding approval of any new
applications listing the firm as a drug product manufacturer
◉ "The SOPs that a company uses to manufacture their product are
included in the chemistry, manufacturing, and controls (CMC)
section of the ____________________________________ that the company
ANSWERS 2026 ACTUAL EXAMINATION TEST
COMPLETE QUESTIONS AND SOLUTIONS
GRADED A+
◉ What is not part of the change control process?
Older SOPs are rendered obsolete
The draft of the revised document is circulated for review
Users are trained prior to the document becoming effective
A master copy of the approved document is retained within the QA
document system
Older SOPs are retained by users. Answer: Older SOPs are retained
by users
◉ A company's change control board is made mainly of members of
the quality assurance and quality control groups
TRUE
FALSE. Answer: FALSE
,◉ The intent of change control system is to determine the need for
actions that would ensure that the system is maintained in a
________________ state.
Innovative
Balanced
Validated
Advance
Modern. Answer: Validated
◉ Small changes to a process can over time can add up and lead to a
product that is no longer what was promised in the New Drug
Application. The result is what is referred to as product ______________.
Creep
Recall
Validation
Failure
Specification
Malfunction. Answer: Creep
, ◉ Some changes would not require approval by the FDA before the
drug product that was manufactured using the changed process can
be distributed.
TRUE
FALSE. Answer: TRUE
◉ What can be a repercussion from an inadequate response to the
violations listed by the FDA to Wockhardt?
Forceful ending of sponsorships and partnerships the firm may have
with similar companies
Reporting only passing test results in laboratory notebooks
Withholding approval of any new applications listing the firm as a
drug product manufacturer
Jail time of a period no less than 5 years for the laboratory manager
and the expulsion of all quality control unit workers
A public media statement by the FDA not recommending the product
to consumers. Answer: Withholding approval of any new
applications listing the firm as a drug product manufacturer
◉ "The SOPs that a company uses to manufacture their product are
included in the chemistry, manufacturing, and controls (CMC)
section of the ____________________________________ that the company
