US RAC Review Questions RAPS Modules Exam , Most Recent
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Written procedures (SOPs) for production and process
control deviation
must meet all the following
criteria except:
A. Must exist for production and process controls
B. Must assure that the drug products have the identity,
strength, quality and purity
C. Must be reviewed and approved by the quality control unit
D. Must be written by the production function - ANSWER-D.
Must be written by the production function
According to GMPs, the following product labels should be
rejected except
which of the
following:
A. Labeling and packaging materials that do not meet the
approved specifications
,B. Labeling and packaging materials that remain at the end of a
production shift
C. Obsolete and outdated labels
D. Gang printed labeling that is not differentiated by size, shape
or color - ANSWER-B. Labeling and packaging materials that
remain at the end of a production shift
How often should employees receive training in GMPs?
A. On an annual
basis
B. Semi-
annually
C.
Annually
D. On a continuing basis - ANSWER-D. On a
continuing basis
GLP study directors are required to conduct the following
activities except:
A. Approving the final study reports
B. Maintenance of the master schedule
C. The protocol is approved and followed
D. Experimental data are accurately reported and verified -
ANSWER-B.
Maintenance of the master schedule
,Standard operating procedures should be generated for the
following GLP
activities
except:
A. Animal
Care
B. Laboratory
Tests
C. Data Handling, Storage and
Retrieval
D. Management of Publications - ANSWER-D. Management
of Publications
Which is a type of administrative enforcement tool that
FDA may use
outside of the US court system or the Department
of Justice?
A. Application Integrity
Policy
B.
Seizure
C.
Injunctio
n
D. Disgorgement - ANSWER-A. Application
Integrity Policy
, GLP documentation archives should have the following
attributes except:
A. Appropriate for laboratory specimens
B. Accessible to all facility personnel
C. Environmentally controlled (temperature and humidity)
D. Secure with controlled access to raw data and
documentation - ANSWER-B. Accessible to all facility
personnel
According to FDA policy, qualified individuals that are non-
MDs can conduct clinical trials as long as an individual listed
as a co- or sub-investigator has one of the following credentials
is except:
A. Doctor of Pharmacy (PharmD)
B. Medical Doctor (MD)
C. Doctor of Dental Science (DDS)
D. Doctor of Osteopathic Medicine (DO) - ANSWER-A. Doctor of
Pharmacy
(PharmD)
Only PharmD does not treat patients
MD, DDS, DO - all treat patients
Institutional Review Boards are responsible for conducting
which of the
|| 2025 /2026 Actual Complete Real Exam Questions With
verified Answers (Correct Answers) Already Graded A+
,Guaranteed success| Newest Exam | Just
Released !!
Written procedures (SOPs) for production and process
control deviation
must meet all the following
criteria except:
A. Must exist for production and process controls
B. Must assure that the drug products have the identity,
strength, quality and purity
C. Must be reviewed and approved by the quality control unit
D. Must be written by the production function - ANSWER-D.
Must be written by the production function
According to GMPs, the following product labels should be
rejected except
which of the
following:
A. Labeling and packaging materials that do not meet the
approved specifications
,B. Labeling and packaging materials that remain at the end of a
production shift
C. Obsolete and outdated labels
D. Gang printed labeling that is not differentiated by size, shape
or color - ANSWER-B. Labeling and packaging materials that
remain at the end of a production shift
How often should employees receive training in GMPs?
A. On an annual
basis
B. Semi-
annually
C.
Annually
D. On a continuing basis - ANSWER-D. On a
continuing basis
GLP study directors are required to conduct the following
activities except:
A. Approving the final study reports
B. Maintenance of the master schedule
C. The protocol is approved and followed
D. Experimental data are accurately reported and verified -
ANSWER-B.
Maintenance of the master schedule
,Standard operating procedures should be generated for the
following GLP
activities
except:
A. Animal
Care
B. Laboratory
Tests
C. Data Handling, Storage and
Retrieval
D. Management of Publications - ANSWER-D. Management
of Publications
Which is a type of administrative enforcement tool that
FDA may use
outside of the US court system or the Department
of Justice?
A. Application Integrity
Policy
B.
Seizure
C.
Injunctio
n
D. Disgorgement - ANSWER-A. Application
Integrity Policy
, GLP documentation archives should have the following
attributes except:
A. Appropriate for laboratory specimens
B. Accessible to all facility personnel
C. Environmentally controlled (temperature and humidity)
D. Secure with controlled access to raw data and
documentation - ANSWER-B. Accessible to all facility
personnel
According to FDA policy, qualified individuals that are non-
MDs can conduct clinical trials as long as an individual listed
as a co- or sub-investigator has one of the following credentials
is except:
A. Doctor of Pharmacy (PharmD)
B. Medical Doctor (MD)
C. Doctor of Dental Science (DDS)
D. Doctor of Osteopathic Medicine (DO) - ANSWER-A. Doctor of
Pharmacy
(PharmD)
Only PharmD does not treat patients
MD, DDS, DO - all treat patients
Institutional Review Boards are responsible for conducting
which of the
