Sterile Compounding, 1st Edition by
Jahangir Moini
Complete Chapter Solutions Manual
are included (Ch 1 to 17)
** Immediate Download
** Swift Response
** All Chapters included
,Table of Contents are given below
1. INTRODUCTION.
2. SAFETY IN THE WORKPLACE .
3. EQUIPMENT, GARMENTS, AND GOWNING.
4. ASEPTIC TECHNIQUE AND CLEAN ROOMS.
5. LAMINAR AIRFLOW WORKBENCHES.
6. PHARMACY CALCULATIONS.
7. STERILE COMPOUNDING AND PREPARATIONS.
8. UNITED STATES PHARMACOPEIA (USP).
9. REPACKAGING, LABELING, STORAGE, DISPOSAL.
10. RECORD-KEEPING REQUIREMENTS.
11. QUALITY CONTROL AND ASSURANCE.
,Solutions Manual organized in reverse order, with the last chapter
displayed first, to ensure that all chapters are included in this
document. (Complete Chapters included Ch11-1)
Solution and Answer Guide
MOINI, ENABULELE, AND SCOTT, STERILE COMPOUNDING 2024, CORE ISBN:
9780357766040; CHAPTER 11: QUALITY CONTROL AND A SSURANCE
TABLE OF CONTENTS
Answer Key with Rationales for End-of-Chapter Questions .............. 1
Multiple Choice .................................................... 1
Fill-in-the-Blank .................................................. 3
Case Study A ....................................................... 5
Case Study B ....................................................... 6
ANSWER KEY WITH RATIONALES FOR END-OF-CHAPTER
QUESTIONS
MULTIPLE CHOICE
1. Which of the following was the first enforceable nationally published
standard for sterile compounding of drugs?
a. USP 797
b. JCAHO
c. HIPAA
d. CDC
Answer: A
Solution: U.S. Pharmacopeia (USP) Chapter 797 was the first enforceable
national published standard defining many quality control areas,
including the sterile compounding of drugs.
2. Which of the following standards are regularly reevaluated and revised
based upon stringent inspection techniques?
a. USP 797
b. The Joint Commission
c. HIPAA
d. CDC
Answer: B
Solution: The Joint Commission standards are regularly reevaluated and
revised based upon stringent inspection techniques. The Joint
Commission publishes standards for the control of pharmaceuticals and
related companies.
3. Which of the following agencies assures that safe and effective drugs
are available in the United States?
a. The Joint Commission
1
, b. Centers for Disease Control and Prevention
c. American Medical Association
d. Center for Drug Evaluation and Research
Answer: D
Solution: The Center for Drug Evaluation and Research (CDER) assures
that safe and effective drugs are available in the United States. It
initially sought to improve the controls set forth in the Pure Food and
Drug Act of 1906.
4. Contaminated multidose vials may cause:
a. infusion.
b. infestation.
c. infection.
d. infarction.
Answer: C
Solution: Contaminated multidose vials may cause infections. When they
are used, they should be refrigerated after opening. The rubber
diaphragm should be cleaned with alcohol before any usage, and touch
contamination should be avoided before the diaphragm is penetrated.
5. Which of the following factors cause medication errors?
a. Pharmacy technicians, during dispensing and calculation
b. Nurses, during administration of medications
c. Physicians, while ordering medications
d. All of the above
Answer: D
Solution: Most errors occur within the drug use process, and are
usually caused by a failure of the system rather than the failure of
one person. Since pharmacy technicians, nurses, and physicians are part
of this system, “all of the above” is the correct answer.
6. Which of the following oversees quality compounding of sterile
products?
a. GMP
b. ASHP
c. The Joint Commission
d. CDER
Answer: A
Solution: The GMP (Good Manufacturing Practices) oversees quality
compounding of sterile products. It is set forth by the Food and Drug
Administration (FDA), and other FDA documents focus on aseptic
processing of sterile products, with proper standards in place that
must be met.
7. Which of the following organizations is responsible for accreditation
of pharmaceutical manufacturers?
a. FDA
b. ASHP
c. The Joint Commission
d. CDC
2
Jahangir Moini
Complete Chapter Solutions Manual
are included (Ch 1 to 17)
** Immediate Download
** Swift Response
** All Chapters included
,Table of Contents are given below
1. INTRODUCTION.
2. SAFETY IN THE WORKPLACE .
3. EQUIPMENT, GARMENTS, AND GOWNING.
4. ASEPTIC TECHNIQUE AND CLEAN ROOMS.
5. LAMINAR AIRFLOW WORKBENCHES.
6. PHARMACY CALCULATIONS.
7. STERILE COMPOUNDING AND PREPARATIONS.
8. UNITED STATES PHARMACOPEIA (USP).
9. REPACKAGING, LABELING, STORAGE, DISPOSAL.
10. RECORD-KEEPING REQUIREMENTS.
11. QUALITY CONTROL AND ASSURANCE.
,Solutions Manual organized in reverse order, with the last chapter
displayed first, to ensure that all chapters are included in this
document. (Complete Chapters included Ch11-1)
Solution and Answer Guide
MOINI, ENABULELE, AND SCOTT, STERILE COMPOUNDING 2024, CORE ISBN:
9780357766040; CHAPTER 11: QUALITY CONTROL AND A SSURANCE
TABLE OF CONTENTS
Answer Key with Rationales for End-of-Chapter Questions .............. 1
Multiple Choice .................................................... 1
Fill-in-the-Blank .................................................. 3
Case Study A ....................................................... 5
Case Study B ....................................................... 6
ANSWER KEY WITH RATIONALES FOR END-OF-CHAPTER
QUESTIONS
MULTIPLE CHOICE
1. Which of the following was the first enforceable nationally published
standard for sterile compounding of drugs?
a. USP 797
b. JCAHO
c. HIPAA
d. CDC
Answer: A
Solution: U.S. Pharmacopeia (USP) Chapter 797 was the first enforceable
national published standard defining many quality control areas,
including the sterile compounding of drugs.
2. Which of the following standards are regularly reevaluated and revised
based upon stringent inspection techniques?
a. USP 797
b. The Joint Commission
c. HIPAA
d. CDC
Answer: B
Solution: The Joint Commission standards are regularly reevaluated and
revised based upon stringent inspection techniques. The Joint
Commission publishes standards for the control of pharmaceuticals and
related companies.
3. Which of the following agencies assures that safe and effective drugs
are available in the United States?
a. The Joint Commission
1
, b. Centers for Disease Control and Prevention
c. American Medical Association
d. Center for Drug Evaluation and Research
Answer: D
Solution: The Center for Drug Evaluation and Research (CDER) assures
that safe and effective drugs are available in the United States. It
initially sought to improve the controls set forth in the Pure Food and
Drug Act of 1906.
4. Contaminated multidose vials may cause:
a. infusion.
b. infestation.
c. infection.
d. infarction.
Answer: C
Solution: Contaminated multidose vials may cause infections. When they
are used, they should be refrigerated after opening. The rubber
diaphragm should be cleaned with alcohol before any usage, and touch
contamination should be avoided before the diaphragm is penetrated.
5. Which of the following factors cause medication errors?
a. Pharmacy technicians, during dispensing and calculation
b. Nurses, during administration of medications
c. Physicians, while ordering medications
d. All of the above
Answer: D
Solution: Most errors occur within the drug use process, and are
usually caused by a failure of the system rather than the failure of
one person. Since pharmacy technicians, nurses, and physicians are part
of this system, “all of the above” is the correct answer.
6. Which of the following oversees quality compounding of sterile
products?
a. GMP
b. ASHP
c. The Joint Commission
d. CDER
Answer: A
Solution: The GMP (Good Manufacturing Practices) oversees quality
compounding of sterile products. It is set forth by the Food and Drug
Administration (FDA), and other FDA documents focus on aseptic
processing of sterile products, with proper standards in place that
must be met.
7. Which of the following organizations is responsible for accreditation
of pharmaceutical manufacturers?
a. FDA
b. ASHP
c. The Joint Commission
d. CDC
2
