CSPT Quality Control and Assurance 4

Question 1

Which statistical method is used to determine if a compounding process is within acceptable limits by plotting data points over time?

Accepted Answer

Control chart (Shewhart chart)

Answer

Control charts (Shewhart charts) plot process data over time to detect trends or shifts that indicate the process is out of statistical control.

Question 2

A batch of sterile compounded preparations fails particulate matter testing. What is the FIRST action the pharmacy should take?

Accepted Answer

Quarantine the entire batch and initiate an investigation

Answer

The entire batch must be quarantined immediately to prevent patient harm while a root-cause investigation is conducted.

Question 3

What does the term 'process validation' mean in sterile compounding?

Accepted Answer

Documented evidence that a process consistently produces a product meeting its specifications

Answer

Process validation provides documented evidence that a compounding process consistently and reproducibly produces a product meeting its predetermined specifications.

Question 4

Per USP <797>, how often must surface sampling for microbial contamination be performed in an ISO 5 PEC during Category 2 compounding?

Accepted Answer

Monthly

Answer

USP <797> requires surface sampling in ISO 5 PECs used for Category 2 CSPs to be performed at least monthly.

Question 5

Which test method uses agar contact plates or swabs applied directly to equipment surfaces to detect microbial contamination?

Accepted Answer

Surface sampling

Answer

Surface sampling uses contact plates (RODAC plates) or swabs directly on surfaces to quantify microbial contamination.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Quality Control and Assurance 4