CFRs

Question 1

Part 210 (Title 21 - Food and Drug)

Answer 1

Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

Question 2

Part 211 (Title 21 - Food and Drug)

Answer 2

Current Good Manufacturing Practice for Finished Pharmaceuticals

Question 3

Part 600 (Title 21 - Food and Drug)

Answer 3

Biological Products; General, transport

Question 4

Part 601 (Title 21 - Food and Drug)

Answer 4

Licensing

Question 5

Part 606 (Title 21 - Food and Drug)

Answer 5

Current Good Manufacturing Practice for Blood and Blood Products, blood labeling, antibody detection, emergency release, nonconformance

Question 6

Part 607 (Title 21 - Food and Drug)

Answer 6

Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products

Question 7

Part 610 (Title 21 - Food and Drug)

Answer 7

General Biological Products Standards (testing, labeling, look back)

Question 8

Part 630 (Title 21 - Food and Drug)

Answer 8

General Requirements for Blood, Blood Components, and Blood Derivatives (notification, education, counseling and referral for donors w/ + I.D. results)

Question 9

Part 640 (Title 21 - Food and Drug)

Answer 9

Additional Standards for Human Blood and Blood Products, plasmapheresis, platelet QC

Question 10

Part 660 (Title 21 - Food and Drug)

Answer 10

Additional Standards for Diagnostic Substances for Laboratory Tests (reagents)

Question 11

Part 820 (Title 21 - Food and Drug)

Answer 11

Quality System Regulation, software requirements

Question 12

Part 1270 (Title 21 - Food and Drug)

Answer 12

Human Tissue Intended for Transplantation

Question 13

Part 1271 (Title 21 - Food and Drug)

Answer 13

Human Cells, Tissues, and Cellular and Tissue-Based Products

Question 14

Part 493 (Title 42- Public Health)

Answer 14

Laboratory Requirements (CLIA), competency assessment, proficiency testing