PRELIM: 1 Flashcards
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.
1901
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.
diphtheria
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.
1930s
First Act required selected dangerous ingredients to be labeled on all drugs.
1906 Pure Food and Drug Act
In _____, nearly 300 people were harmed (some of them died) by one company’s sulfathiazole tablets, a sulfa drug tainted with the sedative Phenobarbital.
1941
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.
sulfanilamide
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.
107
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.”
diethylene glycol
Congress passed the Federal Food, Drug and Cosmetic (FD&C) Act ______
Act of 1938
Obtaining confidence that, required quality of product or service is satisfactory for their intended use.
quality assurance
In1941, nearly 300 people were harmed (some of them died) by one company’s ______ ______, a sulfa drug tainted with the sedative Phenobarbital.
sulfathiazole tablets
(FD&C)
Federal Food, Drug and Cosmetic
In 1941, nearly _____people were harmed (some of them died) by one company’s sulfathiazole tablets, a sulfa drug tainted with the sedative Phenobarbital.
300
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
31 million bottles of Tylenol
In 1941, nearly 300 people were harmed (some of them died) by one company’s sulfathiazole tablets, a sulfa drug tainted with the sedative ________.
Phenobarbital
can also be said as value for price paid.
quality
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.
1960s
is a managerial tool
quality assurance
Part of GMP concerned with sampling, testing and specifications.
quality control
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.
Thalidomide
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.
Europe
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 _______.
fetuses
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.
sleeping pill and to treat morning sickness
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
1980s
ISO 9000 defines as a part of quality management focused on fulfilling quality requirements.
quality control
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.
10,000
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.
1970s
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.
dextrose IV solutions
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.
five
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.
1978
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
acetaminophen capsules
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.
Act in 1983
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.
1989
A measure of excellence or a state of being free from defects, deficiencies and significant variations.
Quality
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.
38 deaths
focuses on how well the product performs its intended function or use.
Quality
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)
Identity
Strength
Safety
Purity
Efficacy
is a wide ranging concept covering all matters that individually or collectively influence the quality of a product.
Quality Assurance
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.
Quality control
It’s the totality of the arrangement made with the objectives of ensuring that pharmaceutical products are of quality required for intended use.
Quality Assurance
is a corrective tool
QUALITY CONTROL
specifies the measure of how well product or service meets the targets.
Quality
