(Midterm) cGMP

Question 1

Consider the following statements:

a) the location of the pharmaceutical industry should be away from environmentally polluted areas.

b) the location should be nearest to the populous area.

Answer 1

a is correct

Question 2

It is acceptable to wear a non-company approve lab gown over your street clothes

Answer 2

FALSE

Question 3

What is the main objective of Production in GMP?

Answer 3

To comply with the principles of Good Manufacturing Practice

Question 4

What is the purpose of calibration in GMP?

Answer 4

To assure that equipment continues to have the desired accuracy

Question 4

It is ok for a light to observed around the perimeter of a dock door as long as it has a seal

Answer 4

FALSE

Question 5

The proper order for hand washing is

Answer 5

wet, lather,scrub, rinse dry

Question 6

The “c” in cGMP stands for

Answer 6

current

Question 7

GMP’s are enforceable by law

Answer 7

TRUE

Question 8

If a manufacturing company does not adhere to cGMP regulations

Answer 8

any drug manufactured by such company will be considered adulterated

Question 9

What is acceptable to store in your personal locker?
a. coffee mugs
b. lunch
c. cologne
d. none of the choices

Answer 9

d. none of the choices

Question 9

What is the purpose of Documentation in GMP?

Answer 9

To document all GMP activities

Question 10

Full time employees are the only people who have to follow all GMP’s

Answer 10

FALSE

Question 11

GMP’s are established and implemented to protect

Answer 11

both consumer and company reputation

Question 12

SOPs are used to ensure consistency in daily operations. What does “S” stands for in SOP

Answer 12

standard

Question 13

Key aspect of GMP for pharmaceutical products

Answer 13

Ensuring that the products are fit for their intended use

Question 14

A class of raw materials, which are to be subjected to tests and assays by the Quality Control department, and are not yet to be use in the production of pharmaceuticals

Answer 14

Quarantined materials

Question 15

What is the role of Quality Control (QC) in GMP?

Answer 15

Testing of bulk components prior to use by production

Question 16

What is the main objective of GMP?

Answer 16

ensure quality and safety of product

Question 17

It is acceptable to use a secondary container for an ingredient as long as the container is properly labelled

Answer 17

TRUE

Question 18

If a documentation error is made, you must

Answer 18

draw a single through it and initial it