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QC2 LECTURE > MODULE 3 > Flashcards

MODULE 3 Flashcards

1
Q

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.

A

Raw Materials

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2
Q

A date of retest.

A

Re-assay Date

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3
Q

Monthly or prior use

A

Highly unstable materials

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4
Q

24 months

A

Active ingredients and excipients

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5
Q

12 months

A

Active ingredients and dye

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6
Q

6 months

A

Vitamins and flavors

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7
Q

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

A

Sampling

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8
Q

It is a specification of sampling.

A

Sampling

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9
Q

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

A

N

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10
Q

Refers to random sample drawn from the lot.

A

n

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11
Q

Refers to the acceptance number.

A

C

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12
Q

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.

A

Double Sampling

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13
Q

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.

A

Single Sampling

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14
Q

Accepted a bad batch.

A

Consumers Risk (Beta Error)

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15
Q

Rejected a good batch.

A

Producer’s risk (Alpha Error)

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16
Q

The acceptance number is specified by AQL.

A

Square-Root Number System

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17
Q

A risk error designated by alpha error.

A

Producer’s risk

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18
Q

A risk error designated by beta error

A

Consumers risk

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19
Q

4 Sources of Quality Variations

A

Materials
Machines
Methods
Men

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20
Q

Variations within a batch.

A

Materials

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21
Q

Aging and improper care.

A

Machines

22
Q

Negligence by chance.

A

Methods

23
Q

Dishonesty, fatigue and carelessness.

A

Men

24
Q

Inexact procedure.

A

Methods

25
Q

Improper working conditions.

A

Men

26
Q

Variations between batches from the same supplier.

A

Materials

27
Q

4 Types of Control Functions

A

Analysis
Monitor
Record, Review and Release
Audit Functions

28
Q

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.

A

Analysis Functions

29
Q

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

A

Monitor Functions

30
Q

Environmental Monitoring

A

Monitor Functions

31
Q

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.

A

Record and Release Functions

32
Q

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

A

Audit Functions

33
Q

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

A

Receiving Tally Report (RTR)

34
Q

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

A

Receiving number

35
Q

Yellow Sticker

A

Quarantine

36
Q

Red Stickers

A

Rejected

37
Q

Green Sticker

A

Approved

38
Q

Raw material container has a
“Hold” sticker.

A

Quarantine

39
Q

Return to the supplier or disposed of promptly.

A

Rejected

40
Q

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

A

First In, First Out (FIFO)

41
Q

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

A

Chemical Identification

42
Q

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

A

Purity

43
Q

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

A

Instrumental Identification

44
Q

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

A

Chemical Identification

45
Q

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

A

Instrumental Identification

46
Q

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

A

Physical

47
Q

Specific gravity of the sample can be determined using Pycnometer.

A

Physical

48
Q

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

A

Limit

49
Q

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

A

Limit

50
Q

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

A

Physical

QC2 LECTURE (5 decks)

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