CSPT - Compounded Sterile Preparation Technician Labeling and Documentation Questions and Answers 3

Question 1

When documenting a deviation from the Master Formulation Record, what is required?

Accepted Answer

The deviation must be documented with reason, approval by designated person, and impact assessment

Answer

Any deviation from the MFR must be formally documented including the nature, reason, approval, and impact assessment.

Question 2

What is the role of Standard Operating Procedures (SOPs) in a sterile compounding program?

Accepted Answer

Mandatory written procedures that define how each process must be performed consistently

Answer

SOPs are mandatory written procedures required by USP 797 for every significant process.

Question 3

What storage condition information is required on a CSP label?

Accepted Answer

Specific storage temperature range, light protection if applicable, and special handling requirements

Answer

CSP labels must include specific storage conditions including temperature range, light protection, and special handling instructions.

Question 4

What documentation is required for environmental monitoring results?

Accepted Answer

All results must be documented, reviewed, and trended regardless of pass or fail

Answer

All environmental monitoring results must be documented, reviewed by the designated person, and trended over time.

Question 5

What is the purpose of a recall procedure in a sterile compounding quality assurance program?

Accepted Answer

To establish a systematic process for retrieving all units of a potentially defective CSP

Answer

A recall procedure provides a systematic process for quickly identifying, locating, and retrieving all units of a CSP that may be defective or contaminated.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Labeling and Documentation Questions and Answers 3