PRELIM: 1

Question 1

children who received antitoxin for diphtheria treatment died of tetanus because the horse serum that had been used to prepare the antitoxin was contaminated with tetanus.

Answer 1

1901

Question 2

children who received antitoxin for __________ treatment died of tetanus because the horse serum that had been used to prepare the antitoxin was contaminated with tetanus.

Answer 2

diphtheria

Question 3

The wrong raw material and an elixir of sulfanilamide, anti-infective drug used. One company used diethylene glycol, a poisonous solvent and chemical analog of antifreeze, in an oral “elixir of sulfanilamide.” Before the problem was discovered, 107 people died, many of them children.

Answer 3

1930s

Question 4

First Act required selected dangerous ingredients to be labeled on all drugs.

Answer 4

1906 Pure Food and Drug Act

Question 5

In _____, nearly 300 people were harmed (some of them died) by one company’s sulfathiazole tablets, a sulfa drug tainted with the sedative Phenobarbital.

Answer 5

1941

Question 6

The wrong raw material and an elixir of __________, anti-infective drug used in 1935. One company used diethylene glycol, a poisonous solvent and chemical analog of antifreeze, in an oral “elixir of sulfanilamide.” Before the problem was discovered, 107 people died, many of them children.

Answer 6

sulfanilamide

Question 7

The wrong raw material and an elixir of sulfanilamide, anti-infective drug used in 1935. One company used diethylene glycol, a poisonous solvent and chemical analog of antifreeze, in an oral “elixir of sulfanilamide.” Before the problem was discovered, ____ people died, many of them children.

Answer 7

107

Question 8

The wrong raw material and an elixir of sulfanilamide, anti-infective drug used in 1935. One company used _________, a poisonous solvent and chemical analog of antifreeze, in an oral “elixir of sulfanilamide.”

Answer 8

diethylene glycol

Question 9

Congress passed the Federal Food, Drug and Cosmetic (FD&C) Act ______

Answer 9

Act of 1938

Question 10

Obtaining confidence that, required quality of product or service is satisfactory for their intended use.

Answer 10

quality assurance

Question 11

In1941, nearly 300 people were harmed (some of them died) by one company’s ______ ______, a sulfa drug tainted with the sedative Phenobarbital.

Answer 11

sulfathiazole tablets

Question 12

(FD&C)

Answer 12

Federal Food, Drug and Cosmetic

Question 13

In 1941, nearly _____people were harmed (some of them died) by one company’s sulfathiazole tablets, a sulfa drug tainted with the sedative Phenobarbital.

Answer 13

300

Question 14

1980s - Poisoned acetaminophen capsules. In 1982, 12-year- old Mary Keller man died after taking an extra-strength Tylenol acetaminophen capsule, Six other people died after taking the same drug. Johnson & Johnson announced a nationwide recall of ____ _____ __ ______ _____. The investigation revealed that a criminal tamper had opened up and laced some capsules with cyanide. The company destroyed all 31 million bottles of the largest-selling over-the counter (OTC) medicine in the country

Answer 14

31 million bottles of Tylenol

Question 15

In 1941, nearly 300 people were harmed (some of them died) by one company’s sulfathiazole tablets, a sulfa drug tainted with the sedative ________.

Answer 15

Phenobarbital

Question 16

can also be said as value for price paid.

Answer 16

quality

Question 17

Thalidomide was marketed in Europe as a sleeping pill and to treat morning sickness. When regulatory agencies gave permission to sell the drug for that indication, they had no knowledge of its serious side effects. It turned out to be teratogenic, It caused serious deformities in developing fetuses.

Answer 17

1960s

Question 18

is a managerial tool

Answer 18

quality assurance

Question 19

Part of GMP concerned with sampling, testing and specifications.

Answer 19

quality control

Question 20

1960s - _______ was marketed in Europe as a sleeping pill and to treat morning sickness. When regulatory agencies gave permission to sell the drug for that indication, they had no knowledge of its serious side effects. It turned out to be teratogenic, It caused serious deformities in developing fetuses.

Answer 20

Thalidomide

Question 21

1960s - Thalidomide was marketed in _______ as a sleeping pill and to treat morning sickness. When regulatory agencies gave permission to sell the drug for that indication, they had no knowledge of its serious side effects. It turned out to be teratogenic, It caused serious deformities in developing fetuses.

Answer 21

Europe

Question 22

1960s - Thalidomide was marketed in Europe as a sleeping pill and to treat morning sickness. When regulatory agencies gave permission to sell the drug for that indication, they had no knowledge of its serious side effects. It turned out to be teratogenic, It caused serious deformities in developing _______.

Answer 22

fetuses

Question 23

1960s - Thalidomide was marketed in Europe as a _____ _______ ________. When regulatory agencies gave permission to sell the drug for that indication, they had no knowledge of its serious side effects. It turned out to be teratogenic, It caused serious deformities in developing fetuses.

Answer 23

sleeping pill and to treat morning sickness

Question 24

Poisoned acetaminophen capsules.12-year- old Mary Keller man died after taking an extra-strength Tylenol acetaminophen capsule, Six other people died after taking the same drug. Johnson & Johnson announced a nationwide recall of 31 million bottles of Tylenol. The investigation revealed that a criminal tamper had opened up and laced some capsules with cyanide. The company destroyed all 31 million bottles of the largest-selling over-the counter (OTC) medicine in the country

Answer 24

1980s

Question 25

ISO 9000 defines as a part of quality management focused on fulfilling quality requirements.

Answer 25

quality control

Question 26

Children whose mothers took thalidomide in the first trimester were born with severely deformed arms and legs. An estimated ________ cases of infant deformities in Europe were linked to thalidomide use.

Answer 26

10,000

Question 27

The Devonport, UK, incident resulted in at least five deaths when drug products designed to be sterile became contaminated and recipients developed infections. An unwritten change to autoclave operation, communicated orally between operators, resulted in dextrose IV solutions that were not uniformly sterile.

Answer 27

1970s

Question 28

In 1970s, The Devonport, UK, incident resulted in at least five deaths when drug products designed to be sterile became contaminated and recipients developed infections. An unwritten change to autoclave operation, communicated orally between operators, resulted in ______ _____solutions that were not uniformly sterile.

Answer 28

dextrose IV solutions

Question 29

In 1970s , The Devonport, UK, incident resulted in at least ______ deaths when drug products designed to be sterile became contaminated and recipients developed infections. An unwritten change to autoclave operation, communicated orally between operators, resulted in dextrose IV solutions that were not uniformly sterile.

Answer 29

five

Question 30

GMPs for drugs (21 CFR Parts 210 and 211) and medical devices (21 CFR 820) were made final in _____. They were intended to help ensure the safety and efficacy of all products.

Answer 30

1978

Question 31

1980s - Poisoned _____ _____. In 1982, 12-year- old Mary Keller man died after taking an extra-strength Tylenol acetaminophen capsule, Six other people died after taking the same drug. Johnson & Johnson announced a nationwide recall of 31 million bottles of Tylenol. The investigation revealed that a criminal tamper had opened up and laced some capsules with cyanide. The company destroyed all 31 million bottles of the largest-selling over-the counter (OTC) medicine in the country

Answer 31

acetaminophen capsules

Question 32

FDA issued tamper-resistant packaging regulations for all OTC human drug products and incorporated them into the GMPs. Congress passed the Federal Anti-Tampering Act _______, making it a crime to tamper with packaged consumer products.

Answer 32

Act in 1983

Question 33

In ____, an outbreak of toxic reactions to over-the- counter tryptophan, a dietary supplement, resulted in 38 deaths and probably thousands of less severe reactions. The event was the result of a manufacturing process change that increased the level of a harmful byproduct. Doses that had previously been safe now caused toxicity.

Answer 33

1989

Question 34

A measure of excellence or a state of being free from defects, deficiencies and significant variations.

Answer 34

Quality

Question 35

In 1989, an outbreak of toxic reactions to over-the- counter tryptophan, a dietary supplement, resulted in ____ deaths and probably thousands of less severe reactions. The event was the result of a manufacturing process change that increased the level of a harmful byproduct. Doses that had previously been safe now caused toxicity.

Answer 35

38 deaths

Question 36

focuses on how well the product performs its intended function or use.

Answer 36

Quality

Question 37

The Regulatory Authorities all over the world have accepted that a pharmaceutical product which meets the following five characteristics can be expected as a quality product . They are— (5)

Answer 37

Identity Strength Safety Purity Efficacy

Question 38

is a wide ranging concept covering all matters that individually or collectively influence the quality of a product.

Answer 38

Quality Assurance

Question 39

concerned release procedure which ensure that the necessary & relevant tests are performed and the product is released for the use only after ascertaining its quality.

Answer 39

Quality control

Question 40

It's the totality of the arrangement made with the objectives of ensuring that pharmaceutical products are of quality required for intended use.

Answer 40

Quality Assurance

Question 41

is a corrective tool

Answer 41

QUALITY CONTROL

Question 42

specifies the measure of how well product or service meets the targets.

Answer 42

Quality