CGMP

Question 1

Part 1 of CGMP

Answer 1

General Provisions

Question 2

Section 1 of Part 1

Answer 2

Authority

Question 3

Section 2 of Part 1

Answer 3

Statement of Policies

Question 4

Section 3 of Part 1

Answer 4

Statement of Objective

Question 5

Statement 4 of Part 1

Answer 5

Definition of terms

Question 6

Nearest value obtained

Answer 6

Accuracy

Question 7

Quantity that is actually produced at any phase of production

Answer 7

Actual yield

Question 8

An enclosed space with two or more door.

Answer 8

Airlock

Question 9

Pass through hatch
Anteroom

Answer 9

Airlock

Question 10

Quantity of product that is homogenous in character

Answer 10

Batch

Question 11

A designation in numbers or letters or combination thereof that identifies the batch

Answer 11

Batch number

Question 12

Contained system such as Fermenter

Answer 12

Biogenerator

Question 13

Container used to store liquified gas

Answer 13

Cryogenic vessel

Question 14

System of Quality assurance

Answer 14

GMP

Question 15

Culture of fully characterized cell

Answer 15

Master cell bank

Question 16

Culture of microorganisms distributed from single bulk

Answer 16

Master seed lot

Question 17

System where successive batches of product are derived from same master

Answer 17

Seed lot system

Question 18

Unit of Blood

Answer 18

Unit

Question 19

Sections of Part 2: 1-7

Answer 19

1 - Personnel
2 - Premises
3 - Equipment
4 - Sanitation and Hygiene
5 - Storage of starting material and finished product
6 - production
7 - QC

Question 20

Set of principles.intended to assure quality and integrity of non-clinical laboratory studies

Answer 20

Good laboratory practice

Question 21

Purpose of GLP

Answer 21

Assure quality and integrity of data submitted
Certify every step of analysis is valid or not
Emphasis data recording

Question 22

3 types of inspection

Answer 22

Study-based inspection
Facility-based inspection
Process-based inspection

Question 23

Evaluate whether the company’s operation remain compliant with GMP

Answer 23

Self inspection

Question 24

Daily or Intermediate correction

Answer 24

Self-inspection Informal

Question 25

Quarterly - Improved system

Answer 25

Self-inspection Formal

Question 26

Yearly - Confirm compliance

Answer 26

Quality control - Internal

Question 27

The quantity that is expected or planned to be obtained at any phase of
production of a particular product, based on the quantity of components to be
used.

Answer 27

Theoretical yield