USP 825 – MPJE UPDATED ACTUAL
Exam Questions and CORRECT Answers
Which USP chapter deals with the preparation, compounding, dispensing, and repackaging of
radiopharmaceuticals? - CORRECT ANSWER - 825
For compounded preparations involving one or more nonsterile components, a
___________________ procedure must be performed prior to dispensing. - CORRECT
ANSWER - Sterilization
For injectable compounded preparations involving one or more components that are not certified
to be pyrogen-free, ___________________ testing must be performed prior to dispensing. -
CORRECT ANSWER - Bacterial endotoxin
What are 4 different types of shielding? - CORRECT ANSWER - -L-block
-Lead torso
-Vial shield
-Syringe shield
Radiation exposure to personnel is directly proportional to what? - CORRECT ANSWER -
-Quantity of radiation handled
-Time handling the RAM
-Distance of the RAM
Which of the following devices CANNOT be placed inside an ISO Class 5 PEC?
-Dose calibrator
-Monitor
-Bar code scanner
-Glove container
-Label printer - CORRECT ANSWER - Glove container
, Successful completion of initial gloved fingertip and thumb sampling is defined as _______ cfu.
- CORRECT ANSWER -0
Successful completion of gloved fingertip and thumb sampling after media-fill testing is defined
as _______ cfu. - CORRECT ANSWER - </+ 3
How often must personnel be visually observed while performing hand hygiene, garbing SOPs,
and aseptic technique procedures? - CORRECT ANSWER - Initially & Q12M
How often must personnel perform fingertip and thumb sampling? - CORRECT
ANSWER - 3 times initially & Q12M
How often must personnel conduct a media-fill test? - CORRECT ANSWER - Initially &
Q12M
Personnel that have not performed radiopharmaceutical processing in more than _______ months
must be requalified in all core competencies before resuming duties. - CORRECT
ANSWER -6
Personnel who perform sterile compounding using a nonsterile drug substances or components
must be requalified in all core competencies every ______ months. - CORRECT
ANSWER -6
T/F: Personnel who are authorized to be within the sterile processing area and do not handle
sterile preparations are still required to complete training on media-fill testing. - CORRECT
ANSWER - False, they are not required to complete training on media-fill testing but are
required. to complete all other training and testing.
Temperature and humidity monitoring devices must be verified for accuracy at least every
______months or as required by the manufacturer. - CORRECT ANSWER - 12
Exam Questions and CORRECT Answers
Which USP chapter deals with the preparation, compounding, dispensing, and repackaging of
radiopharmaceuticals? - CORRECT ANSWER - 825
For compounded preparations involving one or more nonsterile components, a
___________________ procedure must be performed prior to dispensing. - CORRECT
ANSWER - Sterilization
For injectable compounded preparations involving one or more components that are not certified
to be pyrogen-free, ___________________ testing must be performed prior to dispensing. -
CORRECT ANSWER - Bacterial endotoxin
What are 4 different types of shielding? - CORRECT ANSWER - -L-block
-Lead torso
-Vial shield
-Syringe shield
Radiation exposure to personnel is directly proportional to what? - CORRECT ANSWER -
-Quantity of radiation handled
-Time handling the RAM
-Distance of the RAM
Which of the following devices CANNOT be placed inside an ISO Class 5 PEC?
-Dose calibrator
-Monitor
-Bar code scanner
-Glove container
-Label printer - CORRECT ANSWER - Glove container
, Successful completion of initial gloved fingertip and thumb sampling is defined as _______ cfu.
- CORRECT ANSWER -0
Successful completion of gloved fingertip and thumb sampling after media-fill testing is defined
as _______ cfu. - CORRECT ANSWER - </+ 3
How often must personnel be visually observed while performing hand hygiene, garbing SOPs,
and aseptic technique procedures? - CORRECT ANSWER - Initially & Q12M
How often must personnel perform fingertip and thumb sampling? - CORRECT
ANSWER - 3 times initially & Q12M
How often must personnel conduct a media-fill test? - CORRECT ANSWER - Initially &
Q12M
Personnel that have not performed radiopharmaceutical processing in more than _______ months
must be requalified in all core competencies before resuming duties. - CORRECT
ANSWER -6
Personnel who perform sterile compounding using a nonsterile drug substances or components
must be requalified in all core competencies every ______ months. - CORRECT
ANSWER -6
T/F: Personnel who are authorized to be within the sterile processing area and do not handle
sterile preparations are still required to complete training on media-fill testing. - CORRECT
ANSWER - False, they are not required to complete training on media-fill testing but are
required. to complete all other training and testing.
Temperature and humidity monitoring devices must be verified for accuracy at least every
______months or as required by the manufacturer. - CORRECT ANSWER - 12
