Unit 3 Flashcards

1
Q

Each container of raw materials is examined visually for damage or contamination in transit, including breakage of seals when indicated.

A

Materials Control

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2
Q

assigned to each
batch received from the supplier

A

Receiving number

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3
Q

A receiving number is not distinct (T/F)

A

False (Distinct)

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4
Q

It is a completed upon receipt of material.

A

Receiving Tally Report (RTR)

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5
Q

A document used to record the amount
and type of finished goods or raw
materials when a shipment has been
accepted.

A

Receiving tally report

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6
Q

Information under PRE-PRINTED DATA (5)

A

Name of report
Name of drug/cosmetic company
Address
Receiving number
Name of the department receiving a copy

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7
Q

(2) subtypes of INFORMATION TO BE SUPPLIED

A

Warehouse
Quality control

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8
Q

Information under Warehouse

A

Name of the material
Item code number
Label claim
Purchase order number
Invoice number
Vendor (supplier/distributor)
Unit of measure
Number of containers received
Weight/volume/pieces contained in each container.
Date of the report was prepared
Date of the shipment was received
Name of the warehouse personnel receiving the shipment

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9
Q

Information under quality control

A

Inspector’s report
Analysis
Disposition
Name of the person responsible for receiving the report
Date of review

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10
Q

The RTR is prepared not in the warehouse (T/F)

A

False (In warehouse)

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11
Q

Manufacturing firms may have different
entries but the basic information is quite
similar. (T/F)

A

True

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12
Q

These are performed to determine conformance to specifications for properties that can be checked by appearance, odor or flavor.

A

ORGANOLEPTIC INFORMATION

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13
Q

Used as an aid in verifying the identity
of articles as they are purported to be,
e.g., those taken from labeled contain
and to establish whether it is the article
named in USP–NF.

A

IDENTIFICATION TESTS

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14
Q

Used in determination of strength, potency, or
purity of the material.

A

ASSAY

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15
Q

Determines presence of living
organisms which compromises the
quality of the material such as
pathogens

A

MICROBIOLOGICAL TESTS

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16
Q

Tests to limit such substance to amounts
that are unobjectionable under
conditions in which the article is
customarily employed.

A

LIMITS OF IMPURITIES AND FOREIGN
SUBSTANCES

17
Q

Periodic testing is done to revalidate
the material.

A

REASSAY DATE

18
Q

REASSAY DATE of – highly unstable materials

A

Monthly or prior to use

19
Q

REASSAY DATE: vitamins, flavorants

A

6 months

20
Q

REASSAY DATE: active ingredients,
dyes

A

12 MONTHS

21
Q

REASSAY DATE: excipients

A

24 months

22
Q

These tests are intended to
provide protection from light as
specified by the standard.

A

Light Transmission

23
Q

These test are intended to
provide protection from moisture
permeation as specified by the
standard

A

Water Vapor Permeation

24
Q

Used to create rigid translucent
lightweight bottles that can withstand solvents or weak acids and bases.

A

Polyethylene terephthalate (PET)

25
Q

It is durable and resistant to solvents
and other chemicals, although it has poor
vapor permeability

A

Polypropylene (PP)

26
Q

2 kinds of polyethylene

A

High density polyethylene
Low Density Polyethylene

27
Q

This test is performed to ensure
that the material of the container
falls within the range of HDPE
or LDPE as specified in the test.

A

Internal reflectance test

28
Q

This standard determines
endotherms and exotherm
temperatures.

A

Thermal analysis

29
Q

Physicochemical tests of PM is under general chapter <661> (T/F)

A

True

30
Q

Neutral glass, borosilicate (80% silica,
10% boric oxide, and a small amount of sodium
oxide and aluminum oxide) It is chemically inert

A

Type I Highly Resistant
Borosilicate

31
Q

(consisting of 75% silica, sodium oxide,
calcium oxide, and a small fraction of aluminum oxide, potassium oxide)
This glass container has been treated with sulfur to eliminate leachable oxides.

A

Type II Treated Sodalime glass

32
Q

This is an untreated version of soda lime glass
with average chemical resistance. This is used for packing powders, parenteral, and non-parenteral preparations

A

Type III Soda-lime glass

33
Q

Soda lime glass is non-parental (T/F)

A

TRUE