Pharmacy Quality Assurance Flashcards

Which regulatory body requires pharmacies to have a written quality assurance program for compounding?

Answer: USP

USP sets standards for compounding quality assurance, including requirements for written policies and procedures.

A beyond-use date (BUD) for a non-sterile aqueous preparation compounded from commercial drug products and stored at room temperature should not exceed:

Answer: 14 days

Per USP , non-sterile aqueous preparations compounded from manufactured drug products have a BUD of no more than 14 days when refrigerated or at room temperature.

When performing a visual inspection of a compounded sterile preparation (CSP), which finding would require immediate rejection?

Answer: Particulate matter floating in the solution

Visible particulate matter in a sterile preparation is a critical quality defect and the preparation must be rejected immediately.

What is the purpose of an end-product potency test in pharmacy compounding?

Answer: To confirm the correct amount of active ingredient is present

Potency testing verifies that the compounded preparation contains the labeled amount of active pharmaceutical ingredient within acceptable limits.

Which temperature range is considered 'refrigerated' storage per USP standards?

Answer: 2°C to 8°C

USP defines refrigerated storage as a controlled temperature between 2°C and 8°C (36°F to 46°F).

A pharmacy quality assurance program should include which of the following components?

Answer: Medication error tracking and analysis

Medication error tracking and analysis is a core component of a pharmacy QA program to identify patterns and implement corrective actions.

What does a Certificate of Analysis (COA) from a raw material supplier confirm?

Answer: That the material meets specified quality standards

A COA documents that the raw material has been tested and meets identity, purity, potency, and quality specifications.