Quiz

Question 1

What Is Api?

Answer 1

Active Pharmaceutical Ingredient

Question 2

What Is Expient

Answer 2

Inactive Substance Used As A Carrier For Active Ingredients

Question 3

What Do Medical Devices Have To Comply To

Answer 3

(21 CFR 820 for medical device quality)

Question 4

What are CGMP’s

Answer 4

Current Good Manufacturing Practices

Question 5

Role Of CGMP’s

Answer 5

ontain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product

Question 6

What year CGMP’s become law & enforceable?

Answer 6

1979

Question 7

21 CFR 211

Answer 7

CGMP’S for finished pharmaceuticals

Question 8

21 CFR 11

Answer 8

Electronic Record

Question 9

21 CFR 100

Answer 9

Food

Question 10

21 CFR 820

Answer 10

Medical Devices

Question 11

21 CFR 600

Answer 11

Biological Products - General Also CFR 610

Question 12

CFR

Answer 12

Code Of Federal Regulations

Question 13

HEPA

Answer 13

High Efficient Particulate Air

Question 14

PAT

Answer 14

Process Analytical Technology - System For designing analyzing controlling manufacturing through timely measurements

Question 15

CTQ

Answer 15

Critical To Quality - Designed Experiements

Question 16

CDER

Answer 16

Center For Drug Evaluation Research

Question 17

Setpoint

Answer 17

Desired Value Of The Process

Question 18

Process Variable

Answer 18

Aspect Of The Process That Is Being Controlled

Question 19

How Is Personnel Controlled

Answer 19

CFR 211

Question 20

Why Do We Need GMP’s

Answer 20

Ensure That Finish Devices Will Be Safe And Effective

Question 21

What Are Quality System Requirements?

Answer 21

When A Manufacturer Shall Establish a quality system that is appropriate with 21 CFR

Question 22

What Is CFR 21?

Answer 22

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA),

Question 23

What Is QA?

Answer 23

Quality Assurance Or Quality Audit

Question 24

What Kind Of Personnel/Workers Is Needed?

Answer 24

sufficient personnel with appropriate background and training for manufacturing activities

Question 25

Design Controls

Answer 25

establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met

Question 26

Identification and Traceability

Answer 26

establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups. Also Tracing batches

Question 27

What Is Prodcution Process Control?

Answer 27

develop, conduct, control, and monitor production processes to ensure that a device or product conforms to its specifications

Question 28

What Is Part Of Process Control

Answer 28

documented instructions, SOPs, and methods

Question 29

CFR Part 200?

Answer 29

Pharmaceuticals

Question 30

CFR Part 700?

Answer 30

Cosmetics

Question 31

Finish Statement Equipment Shall be constructed so that surfaces that–
shall not be—
so as to alter—

Answer 31

contact components in process material or drug products shall not be reactive additive or absorptive
the safety identitity strength or the drug beyond the requirements

Question 32

What is eCFR

Answer 32

electronic code of federal regulations