random CFRs and dates

Question 1

211.25

Answer 1

personnel qualifications

Question 2

211.28

Answer 2

personnel responsibilities

Question 3

211.42

Answer 3

specific requirements for aseptic processes

Question 4

210.3

Answer 4

gang-printed labeling: mass printing of labels for more than one item

Question 5

cut labels - special restrictions

Answer 5

100% = electromechanical inspection after application
200% = visual inspection for hand-applied labels

Question 6

Biologics Control Act

Answer 6

• 1902
• because of tetanus contaminated smallpox vaccine from horse
• pre-market approval for biologics

Question 7

Pure Food and Drugs Act

Answer 7

• 1906, also Wiley Act
• first federal law to regulate food and drugs
• prohibits interstate commerce in misbranded and adulterated food, drink, and drugs

Question 8

FFDCA

Answer 8

• 1938
• due to elixir sulfanilamide crisis (solvent = highly toxic antifreeze)
• prove products are safe before marketing
• first use of good manufacturing practices

Question 9

Kefauver-Harris Amendments

Answer 9

• 1962, to FFDCA
• due to morning sickness sedative, thalidomide
• use of cGMPs became prevalent
• must prove safety and efficacy before FDA approves commercialization

Question 10

FDA Amendments Act

Answer 10

• 2007
• post-market surveillance

Question 11

211.89

Answer 11

Reject in process materials = quarantine

Question 12

211.103

Answer 12

Calculation of yields

Question 13

211.105

Answer 13

Equipment identification

Question 14

211.182

Answer 14

Equipment logs

Question 15

211.111

Answer 15

Time limitations on production

Question 16

211.113

Answer 16

Control of microbial contamination

Question 17

211.192

Answer 17

Production record review and disposition

Question 18

211.196

Answer 18

Distribution records

Question 19

211.192

Answer 19

Annual review of records

Question 20

211.115

Answer 20

Reprocessing

Question 21

major change control

Answer 21

affects product process, facility systems, or equipment process (ex. incubation time would affect product quality)

Question 22

minor change control

Answer 22

impact some of the process but not the final product characteristics (ex. new equipment affects production time but not product)

Question 23

critical change control

Answer 23

alters product all together and/or impacts product process quality (ex. product formulation change)

Question 24

211.142

Answer 24

Warehouse Procedures

Question 25

211.150

Answer 25

Distribution Procedures

Question 26

211.110

Answer 26

Sampling and Testing of In-process materials and drug products