Quality Management, Safety, and Patient Compliance Part 7

Question 1

A QA program consists of a way to monitor, evaluate, correct, and then improve all of the aspects of compounding sterile preparations. Anyone who is involved in the delivery of medication should be included in this QA process, including, but not limited to:

Answer 1

technicians, pharmacists, physicians, nurses, and others in supportive roles

Question 2

The plan should include SOPs to describe processes and ____ associated with each

Answer 2

responsible persons

Question 3

The process should include SOPs that outline:

Answer 3

tasks, environmental controls, validation methods, and provide education and training

Question 4

Reporting of adverse events of CSP must be reviewed promptly, and if serious or unexpected adverse events are evident, they must be reported to FDA through ____

Answer 4

MedWatch

Question 5

If it is animal-related, the ____ should be used

Answer 5

Form FDA 1932a