Quiz 1

Question 1

What does quality mean

Answer 1

quality means that the the product meets the requirement for safety and effectiveness in it’s intended use

Question 2

What is quality in compliance with?

Answer 2

laws, regulations and guidelines

Question 3

What do cGMP guidelines consist of?

Answer 3

regulations and guidelines applicable for drugs and devices manufactured for human use, including investigation products.

Question 4

What led to the “Drug Importation Act of 1848”?

Answer 4

soldiers death resulting from imported quinine

Question 5

What did the “Drug Importation Act of 1848” call for?

Answer 5

required all medication entering the US to be inspected and analyzed for “quality, purity, and fitness for medical purposes”

Question 6

What set the standards to ensure the quality of medicine?

Answer 6

US Pharmacopoeia

Question 7

What lead to the creation of US Pharmacopoeia?

Answer 7

Mexican American War 1848–> Resulting the enactment of Drug Importation Act

Question 8

What led to the “Biologic Control Act of 1902”

Answer 8

Tetanus contaminated serum was used to produce diphtheria antitoxin that killed children

Question 9

What act required the federal government to issue pre-market approval for biological drugs?

Answer 9

Biologics Control Act of 1902

Question 10

what was administered as a drug but there were no proven medical benefits?

Answer 10

Patent Medicines

Question 11

What is the pure food and drug act also called?

Answer 11

Wiley Act

Question 12

What was the first federal law to regulate food and drugs?

Answer 12

Pure Food and Drug Act of 1906

Question 13

What did the ‘Pure Food and Drug Act do’?

Answer 13

• prohibit interstate commerce in misbranded and adulterated food, drinks, and drugs
• mandated label warning on habit-forming drugs
  > It could not be false or misleading
  > had to list certain substances including AMCH
  (Alcohol, Morphine, Cocaine, and Heroin)

Question 14

1862

Answer 14

Bureau of Chemistry, under the US Department of Agriculture

Question 15

1927

Answer 15

BOC–> became FDIA

Question 16

1930

Answer 16

FDIA–> became FDA

Question 17

1933

Answer 17

FDA recommend complete review of the Food and Drug Act

Question 18

What was the Crisis of 1937

Answer 18

Elixir Sulfanilamide of 1937; Sulfanilamide was used to treat streptococcal infection, someone began to market the liquid sulfa drugs. The Solvent used was a highly toxic variant of antifreeze

Question 19

What was the Federal Food, Drug and Cosmetics Act of 1938 (FEDAC)

Answer 19

• manufactures were required to prove that products are safe before marketing
• required drugs to be manufactured under adequate control
• Required labels with direction for safe use
• First use of GMP to set tolerance for toxic substances
• this is now the main law

Question 20

What was the crisis of 1941

Answer 20

Sedative in Antibiotic 1941: nearly 300 deaths and injuries from sulfanthizole tablets tainted with phenobarbital. The FDA then changed manufacturing and quality controls which led to GMPs

• Segregation of finished batch until all lab tests are done
• lab controls on testing of raw material and finished products
• adequate supervision of Key Equipment

Question 21

What was the Crisis of Thalidomide babies in 1962?

Answer 21

this led to the K-Harris Amendment to FFDCA of 1962

Question 22

What was the K-Harris Amendment to FFDCA of 1962?

Answer 22

• required the drug makers to prove the safety and efficacy of the drug before it’s use
• use of cGMP became prevalent
• 1936 first set of cGMP were published

Question 23

What were some changes to the cGMP

Answer 23

• revised and published in 1970 in the CFR 21 part 210 and 211
• Modern day drug and devices cGMP are result of revision in 1978
• 2004 pharmaceutical cGMP for the 21st century- A risk based approach