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PHA 339 Pharmaceutical Compounding and Analytical Instruments Qualification

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18 Questions

Which of the following is NOT a key aspect of the compounding verification process according to the text?

Calculating the cost of the compounded preparation

What is the main purpose of the quality assurance program in a compounding facility according to the text?

To ensure the safety of the compounded preparations

When collecting samples for testing during the compounding process, which factor should compounding professionals consider?

The physical state of the samples (solid, liquid, or gas)

Which of the following types of testing is NOT mentioned in the text as being required for pharmacy compounding?

Potency testing

Which of the following is a key aspect of the compounding verification process?

Knowing the limits of the testing methods used

What is the primary purpose of the sampling requirements outlined in the text?

To ensure the compounded preparation meets quality and safety standards

What is the purpose of documentation in pharmaceutical compounding?

To provide a record of all aspects of compounding operations and procedures

What is NOT a component of pharmaceutical compounding quality assurance program?

Patient diagnosis

Which step is NOT part of the verification process in pharmaceutical compounding?

Storage

Which of the following is NOT a requirement during the compounding procedure?

In-house testing

What is a key aspect of the testing phase during pharmaceutical compounding?

Component quality evaluation

Why do personnel involved in nonsterile or sterile compounding require additional training beyond routine dispensing duties?

To ensure safety and compliance with regulations

Which of the following is NOT a valid method for documenting beyond-use dating and sterility studies?

Anecdotal evidence from compounding professionals

What does the verification of a compounding procedure involve?

Checking the calculations, weighing and measuring, order of mixing, and compounding techniques

When should the quality of ingredients be verified?

Upon receipt of the ingredients

What should be determined prior to testing a compounded preparation?

The acceptance criteria for the tests

What should a quality assurance program for compounded preparations include?

All of the above

What is the purpose of verification in the context of compounding?

To authoritatively confirm that a process, procedure, or equipment is functioning properly and producing the expected results

This quiz covers Quality assurance aspects of pharmaceutical compounding (USP 1163), steps of Analytical Instruments Qualification (USP 1058), and the Validation Process including Accuracy, Specificity, Precision, Detection limits, Quantification limits, Linearity and Range, Robustness (USP 1225). It also explores components like training, standard operating procedures (SOPs), documentation, verification, testing, and cleaning.

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