QA/ QUALITY CONTROL EXAM 1 QUESTIONS AND
ANSWERS
Quiz 1
"In the eyes of the FDA , the quality of drugs and devices can be assured by adherence
to:"
a. laws, regulations, and guidance
b. current good manufacturing practices
c. laws and regulations
d. laws and guidance
e. all the other choices are correct
f. regulations and guidances - Answers - e. all the other choices are correct
"What quality attribute was required of drugs prior to marketing in the Kefauver-Harris
Amendments of 1962, but not in the Food Drug and Cosmetic Act of 1938?"
a. Purity
b. Fitness
c. Efficacy
d. Strength
e. Safety - Answers - c. Efficacy
The main objective of ICH is to harmonize the
a. Technical requirements for the distribution of pharmaceuticals for human use
b. Technical requirements for the registration of pharmaceuticals for human use
c. Technical requirements for the design of pharmaceuticals for human use
d. Technical requirements for the regulation of pharmaceuticals for human use
,e. Technical requirements for the manufacture of pharmaceuticals for human use -
Answers - b. Technical requirements for the registration of pharmaceuticals for human
use
"The Food, Drug, and Cosmetic Act was legislated in 1938 in response to deaths due
to:"
a. adulterated antitoxin preparation
b. absence of the active pharmaceutical ingredient in a marketed drug
c. high levels of alcohol in formulated sulfanilamide
d. "presence of habit-forming cocaine, heroine and mophine in a cough medicine"
e. "laws, regulations, and guidance" - Answers - c. high levels of alcohol in formulated
sulfanilamide
A drug will not be considered adulterated if:
a. "the drug fails to meet the requirements of FFDCA as to safety, identity, and strength,
which it purports or is represented to possess."
b. "the drug does not have the quality and purity characteristics, which it purports or is
represented to possess."
c. "the facilities or controls used for the drugs packing, or holding are in conformity with
current good manufacturing practice "
d. "the methods used in its manufacture and processing of the drug do not conform with
current good manufacturing practices as required in the FFDCA for the drug to meet the
quality characteristics, which it is represented to possess."
e. "the facillities used in the drug's packing or holding , were not operated or
administered to assure that such drug meets the FFDCA requirements as to safety,
identity, and strength" - Answers - c. "the facilities or controls used for the drugs
packing, or holding are in conformity with current good manufacturing practice "
The primary focus of quality management principles is to meet or exceed
_________________ requirements and expectations.
a. Customer
, b. Personnel
c. Management
d. Leaders
e. Physician - Answers - a. Customer
What applies to ISO9000 but not to GMP regulations?
a. ISO9000 regulations apply only to the pharma or medical industry
b. ISO9000 originated in the United States
c. Compliance with ISO9000 is required by law
d. Quality manual is not required by ISO9000 to provide an overview of the company's
quality system
e. Compliance with ISO9000 standards is monitored by a paid auditor who provides
suggestion for quality improvement - Answers - e. Compliance with ISO9000 standards
is monitored by a paid auditor who provides suggestion for quality improvement
What is not a major benefit in internal operations that comes with a company being ISO
certified?
a. ISO certification leads to greater quality awareness by employees
b. ISO certification tends to increase scrap and product rework expenses
c. "ISO certification leads to enhanced communication among raw material suppliers,
manufacturers, and distributors"
d. ISO certification leads to improved manufacturing efficiency & productivity
e. ISO certification leads to improved documentation - Answers - b. ISO certification
tends to increase scrap and product rework expenses
"Drugs, unlike devices, :"
a. are recognized in the US Pharmacopeia-National Formulary
b. do not need to be metabolized to achieve their intended medical uses
ANSWERS
Quiz 1
"In the eyes of the FDA , the quality of drugs and devices can be assured by adherence
to:"
a. laws, regulations, and guidance
b. current good manufacturing practices
c. laws and regulations
d. laws and guidance
e. all the other choices are correct
f. regulations and guidances - Answers - e. all the other choices are correct
"What quality attribute was required of drugs prior to marketing in the Kefauver-Harris
Amendments of 1962, but not in the Food Drug and Cosmetic Act of 1938?"
a. Purity
b. Fitness
c. Efficacy
d. Strength
e. Safety - Answers - c. Efficacy
The main objective of ICH is to harmonize the
a. Technical requirements for the distribution of pharmaceuticals for human use
b. Technical requirements for the registration of pharmaceuticals for human use
c. Technical requirements for the design of pharmaceuticals for human use
d. Technical requirements for the regulation of pharmaceuticals for human use
,e. Technical requirements for the manufacture of pharmaceuticals for human use -
Answers - b. Technical requirements for the registration of pharmaceuticals for human
use
"The Food, Drug, and Cosmetic Act was legislated in 1938 in response to deaths due
to:"
a. adulterated antitoxin preparation
b. absence of the active pharmaceutical ingredient in a marketed drug
c. high levels of alcohol in formulated sulfanilamide
d. "presence of habit-forming cocaine, heroine and mophine in a cough medicine"
e. "laws, regulations, and guidance" - Answers - c. high levels of alcohol in formulated
sulfanilamide
A drug will not be considered adulterated if:
a. "the drug fails to meet the requirements of FFDCA as to safety, identity, and strength,
which it purports or is represented to possess."
b. "the drug does not have the quality and purity characteristics, which it purports or is
represented to possess."
c. "the facilities or controls used for the drugs packing, or holding are in conformity with
current good manufacturing practice "
d. "the methods used in its manufacture and processing of the drug do not conform with
current good manufacturing practices as required in the FFDCA for the drug to meet the
quality characteristics, which it is represented to possess."
e. "the facillities used in the drug's packing or holding , were not operated or
administered to assure that such drug meets the FFDCA requirements as to safety,
identity, and strength" - Answers - c. "the facilities or controls used for the drugs
packing, or holding are in conformity with current good manufacturing practice "
The primary focus of quality management principles is to meet or exceed
_________________ requirements and expectations.
a. Customer
, b. Personnel
c. Management
d. Leaders
e. Physician - Answers - a. Customer
What applies to ISO9000 but not to GMP regulations?
a. ISO9000 regulations apply only to the pharma or medical industry
b. ISO9000 originated in the United States
c. Compliance with ISO9000 is required by law
d. Quality manual is not required by ISO9000 to provide an overview of the company's
quality system
e. Compliance with ISO9000 standards is monitored by a paid auditor who provides
suggestion for quality improvement - Answers - e. Compliance with ISO9000 standards
is monitored by a paid auditor who provides suggestion for quality improvement
What is not a major benefit in internal operations that comes with a company being ISO
certified?
a. ISO certification leads to greater quality awareness by employees
b. ISO certification tends to increase scrap and product rework expenses
c. "ISO certification leads to enhanced communication among raw material suppliers,
manufacturers, and distributors"
d. ISO certification leads to improved manufacturing efficiency & productivity
e. ISO certification leads to improved documentation - Answers - b. ISO certification
tends to increase scrap and product rework expenses
"Drugs, unlike devices, :"
a. are recognized in the US Pharmacopeia-National Formulary
b. do not need to be metabolized to achieve their intended medical uses
