BTECH Exam 12,13 Questions &
Answers 2024/2025
Q1
What is the first Act that required the inclusion of name and place of manufacture of drug in drug labels?
- ANSWERSFair Packaging and Labeling Act
What is a well built quality system not designed to prevent or reduce the number of? -
ANSWERSEfficacious products entering the marketplace
FDA's ____________ are guidelines that intend to integrate quality systems and risk management
approaches into its existing programs with the goal of encouraging industry to adopt innovative
manufacturing technolofies - ANSWERSpharmaceutical cGMPs for the 21st Century
What is correct about off-label drug use and off-label advertising? - ANSWERS- Off-label advertising is
considered illegal
- Off-label advertising is when a drug manufacturer, or its representative, promotes the use of an
approved drug for an indication for which it is not FDA-approved for.
- Off-label use is generally an acceptable practice
- Off-label prescribing is practiced by a physician
NOT
Off-label use is when a physician prescribes a drug for an indication for which its use had been approved
by the FDA
According to the concept of Quality by Design, quality should be built into the product because testing
alone of _________ cannot be relied on to ensure product quality - ANSWERSFinal Drug Product
A pre-clearance is required by the FDA prior to launch of advertising and promotional materials for drugs
- ANSWERSFalse, for the most part
, Is not required
Which section of prescription drug labels exist when a drug could cause adverse health effects to a
patient subset with certain health conditions - ANSWERSContraindications
Reserve samples are retained by a manufacturer for retests in case of costumer complaints or safety
issues with marketed drugs. What is true of regulations regarding reserve samples? - ANSWERS- Reserve
samples should be retained at least 1 year after expiration date of the last lot
- Reserve samples from each marketed lot should be retained.
- At least twice the quantity needed for all tests to be performed should be retained
- Drug product reserve samples should be retained and stored in the same container and closure as the
marketed form
NOT
drug product reserve samples should always be stored at low temperatures
What information would be found in both executed batch record and the master batch record? -
ANSWERSdetailed manufacturing, processing, packaging, and holding instructions
What is correct about cGMP requirements for testing prior to release for distribution of drug products -
ANSWERS- Test methods should be accurate, sensitive, specific, and reproducible
- Sampling design should be statistically sound
- Microbiological tests should be conducted only if necessary for a particular drug product
- Tests should be performed to determine conformance to specifications prior to release of each batch
NOT
tests should be performed by the quality assurance unit
A component of cGMP for the 21st century is modern _____________ which involves real time data
acquisition and timely analysis of critical parameters to attain better process control and timely decision
making on proper course of actions. - ANSWERSProcess Analytical Technologies
Answers 2024/2025
Q1
What is the first Act that required the inclusion of name and place of manufacture of drug in drug labels?
- ANSWERSFair Packaging and Labeling Act
What is a well built quality system not designed to prevent or reduce the number of? -
ANSWERSEfficacious products entering the marketplace
FDA's ____________ are guidelines that intend to integrate quality systems and risk management
approaches into its existing programs with the goal of encouraging industry to adopt innovative
manufacturing technolofies - ANSWERSpharmaceutical cGMPs for the 21st Century
What is correct about off-label drug use and off-label advertising? - ANSWERS- Off-label advertising is
considered illegal
- Off-label advertising is when a drug manufacturer, or its representative, promotes the use of an
approved drug for an indication for which it is not FDA-approved for.
- Off-label use is generally an acceptable practice
- Off-label prescribing is practiced by a physician
NOT
Off-label use is when a physician prescribes a drug for an indication for which its use had been approved
by the FDA
According to the concept of Quality by Design, quality should be built into the product because testing
alone of _________ cannot be relied on to ensure product quality - ANSWERSFinal Drug Product
A pre-clearance is required by the FDA prior to launch of advertising and promotional materials for drugs
- ANSWERSFalse, for the most part
, Is not required
Which section of prescription drug labels exist when a drug could cause adverse health effects to a
patient subset with certain health conditions - ANSWERSContraindications
Reserve samples are retained by a manufacturer for retests in case of costumer complaints or safety
issues with marketed drugs. What is true of regulations regarding reserve samples? - ANSWERS- Reserve
samples should be retained at least 1 year after expiration date of the last lot
- Reserve samples from each marketed lot should be retained.
- At least twice the quantity needed for all tests to be performed should be retained
- Drug product reserve samples should be retained and stored in the same container and closure as the
marketed form
NOT
drug product reserve samples should always be stored at low temperatures
What information would be found in both executed batch record and the master batch record? -
ANSWERSdetailed manufacturing, processing, packaging, and holding instructions
What is correct about cGMP requirements for testing prior to release for distribution of drug products -
ANSWERS- Test methods should be accurate, sensitive, specific, and reproducible
- Sampling design should be statistically sound
- Microbiological tests should be conducted only if necessary for a particular drug product
- Tests should be performed to determine conformance to specifications prior to release of each batch
NOT
tests should be performed by the quality assurance unit
A component of cGMP for the 21st century is modern _____________ which involves real time data
acquisition and timely analysis of critical parameters to attain better process control and timely decision
making on proper course of actions. - ANSWERSProcess Analytical Technologies
