Quality Management, Safety, and Patient Compliance Part 5

Question 1

USP guidelines provide a sampling plan for air and surface compounding areas

Answer 1

797

Question 2

Labels for CSPs should include:

Answer 2

correct amounts and names of all ingredients, total volume, appropriate route of administration, and storage conditions

Question 3

All finished CSPs should undergo ____ testing, either visual or sterility depending on the assigned BUD.

Answer 3

release

Question 4

After successfully completing hand hygiene and garbing, compounding personnel should have their techniques tested per USP guidelines. This is accomplished by performing media fill tests. This is recorded in the personnel’s record and repeated quarterly.
The basic procedure is as follows:

Answer 4

• Perform test during the most challenging compound during a normal work shift
• Do not interrupt the test once started
• If all components are sterile, transfer a sterile soybean-case in digest into a similar container to simulate the process. There are kits available for this process
• Incubate the media-filled vials at 20 to 35 °C, for a minimum of 14 days, or one lower and one higher temperature for 7 days each, depending on media growth used
• Review the results with personnel and if needed, repeat the test.

Question 5

Every compounder must undertake refresher training ____ in the core competencies, such as visual observations, sampling, media fill, cleaning and disinfecting, and after any pause of 3 months or more in compounding

Answer 5

annually