MODULE 3

Question 1

It is a CGMP requirement that all raw materials, active or
inactive, be assigned a meaningful reassay date that
assures the purity and potency at the time of use.

Answer 1

Raw Materials

Question 2

A date of retest.

Answer 2

Re-assay Date

Question 3

Monthly or prior use

Answer 3

Highly unstable materials

Question 4

24 months

Answer 4

Active ingredients and excipients

Question 5

12 months

Answer 5

Active ingredients and dye

Question 6

6 months

Answer 6

Vitamins and flavors

Question 7

A definite working rule
regarding size and frequency of sample and
the basis for acceptance or rejection.

Answer 7

Sampling

Question 8

It is a specification of sampling.

Answer 8

Sampling

Question 9

Refers to lot or batch from which the sample
is drawn.

Answer 9

N

Question 10

Refers to random sample drawn from the lot.

Answer 10

n

Question 11

Refers to the acceptance number.

Answer 11

C

Question 12

A second sample for inspection is permitted if
the first fails, and two acceptance numbers are
used - the first applying to the observed
numbers of defectives for the 1rst sample alone
and the second applying to the observed
number of defectives for the 1rst and second
samples combined.

Answer 12

Double Sampling

Question 13

Only a specified sample size is inspected before
a decision is reached regarding the disposition
of the batch, and the acceptance criterion is
expressed as an acceptance number.

Answer 13

Single Sampling

Question 14

Accepted a bad batch.

Answer 14

Consumers Risk (Beta Error)

Question 15

Rejected a good batch.

Answer 15

Producer’s risk (Alpha Error)

Question 16

The acceptance number is specified by AQL.

Answer 16

Square-Root Number System

Question 17

A risk error designated by alpha error.

Answer 17

Producer’s risk

Question 18

A risk error designated by beta error

Answer 18

Consumers risk

Question 19

4 Sources of Quality Variations

Answer 19

Materials
Machines
Methods
Men

Question 20

Variations within a batch.

Answer 20

Materials

Question 21

Aging and improper care.

Answer 21

Machines

Question 22

Negligence by chance.

Answer 22

Methods

Question 23

Dishonesty, fatigue and carelessness.

Answer 23

Men

Question 24

Inexact procedure.

Answer 24

Methods

Question 25

Improper working conditions.

Answer 25

Men

Question 26

Variations between batches from the same supplier.

Answer 26

Materials

Question 27

4 Types of Control Functions

Answer 27

Analysis Monitor Record, Review and Release Audit Functions

Question 28

Tests are made not only on the raw materials and packaging components but also on the bulk product during processing and after packaging prior its release to the market.

Answer 28

Analysis Functions

Question 29

It is the responsibility of quality control to sample and examine materials while they are being processed.

Answer 29

Monitor Functions

Question 30

Environmental Monitoring

Answer 30

Monitor Functions

Question 31

It is responsible for carefully reviewing the batch record for that lot and assuring that all necessary records are present, complete and were feasible to determine if it is accurate.

Answer 31

Record and Release Functions

Question 32

The quality audit is designed to detect areas where the established SOP's are not being followed andto report these findings to the supervisor for appropriate action

Answer 32

Audit Functions

Question 33

A _________ (reception of materials, incoming cargo report, receiving report or receiving ticket) should be prepared for every shipment.

Answer 33

Receiving Tally Report (RTR)

Question 34

As each batch of incoming material is received, it is given a ___________by which it will be identified in subsequent operations.

Answer 34

Receiving number

Question 35

Yellow Sticker

Answer 35

Quarantine

Question 36

Red Stickers

Answer 36

Rejected

Question 37

Green Sticker

Answer 37

Approved

Question 38

Raw material container has a “Hold” sticker.

Answer 38

Quarantine

Question 39

Return to the supplier or disposed of promptly.

Answer 39

Rejected

Question 40

Policy that rotated in such a manner that the oldest stock is used first.

Answer 40

First In, First Out (FIFO)

Question 41

The QC Analyst uses chemicals to confirm the identity of the sample.

Answer 41

Chemical Identification

Question 42

Titration was performed to determine the amount of active ingredient present on the sample.

Answer 42

Purity

Question 43

Using IR spectroscopy, it can identify the functional groups present in the sample.

Answer 43

Instrumental Identification

Question 44

Chemical reaction was done to confirm the complete reaction via precipitation, color change or evolution of gas.

Answer 44

Chemical Identification

Question 45

HPLC was used to determine the exact composition of the substance.

Answer 45

Instrumental Identification

Question 46

Organoleptic characteristics are tested with your senses, including visual appearance, aroma, and flavor.

Answer 46

Physical

Question 47

Specific gravity of the sample can be determined using Pycnometer.

Answer 47

Physical

Question 48

Using the flame photometry, it can determine the limit of chemicals (Na, Chlorides, Sulfates, and Ca) present on the sample.

Answer 48

Limit

Question 49

Microbiological limits for spoilage organisms or indicators of poor sanitation, including total plate count, yeast, mold, and coliform.

Answer 49

Limit

Question 50

Solubility test can determine the dissolution of the compound in a suitable solvent.

Answer 50

Physical