Module9 QuizQuality Control and Assurance

Sterile Product Certification Course

1. Quality improvement assumes that ______.

a. proper procedures are followed

b. storage, handling and stability are not compromised

c. while processes are performed over time, integrity is not lost

d. both a and b

2. Essential quality improvement tasks include ______.

a. maintaining trends

b. taking corrective measures

c. making suggestions for change

d. all of the above

3. Medication errors usually happen as a result of ______.

a. untrained personnel

b. low quality products

c. system failures

d. negligence

4. Various agencies have issued guidelines to help establish ______.

a. standard practices

b. official documentation

c. high quality control

d. accreditation

5. The appropriate temperature range for a product placed under refrigeration is ______.

a. 0°C to 10°C

b. 5°C to 10°C

c. 1°C to 5°C

d. 2°C to 8°C

6. Sterile products should be properly labeled with ______.

a. patient name, prescribed regimen, ingredients

b. patient identification, lot numbers, concentrations

c. expiration date, patient name, auxiliary labels

d. all of the above

7. Record or documentation that illustrates how a product is made is referred to as a(n) ______.

a. USP

b. SOP

c. BSA

d. CDC

8. Quality assurance includes:

a. personnel training and assessment

b. environmental control and monitoring

c. SOPs and P&Ps

d. all of the above

9. Random checks can be described as a quality assurance procedure known as ______.

a. validation process

b. assessment

c. quality improvement

d. documentation

10. When unsure of which risk level a specific product falls under, it is best to ______.

a. ask the pharmacist

b. ask a CPhT

c. choose the most stringent risk level

d. choose the risk level used last time product was made

11. Batch testing can be described under the quality assurance function known as ______.

a. monitoring

b. quality audit

c. end-product evaluation

d. all of the above

12. Suggestions as to how a process more effective can best be described under which QA function?

a. validation

b. end product evaluation

c. training

d. improvement

13. The way medications are packaged, prepared and delivered can best be described as part of which QA function?

a. facilities and equipment

b. storage and handling

c. aseptic technique

d. documentation and labeling

14. Proper documentation includes patient information and a ______that records specific information regarding the preparation and final product.

a. SOP

b. label

c. worksheet

d. spreadsheet

15. Risk level 3 products are those that require refrigeration to extend expiration dates.

a. True

b. False

A Learning Assessment for ACPE Program # 384-000-0905-000-C04

Copyright © 2006 by STAT Educational Services/NPTA – National Pharmacy Technician Association, Inc. Houston, Texas77068

Based upon The Pharmacy Technician Series: Sterile Products published by Pearson Education, Inc. ISBN 0-13-114756-0