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Qc Lec > Unit 5 > Flashcards

Unit 5 Flashcards

1
Q

flow of quality drug product onto the market relies upon

A

controlled and consistent pharmaceutical
manufacturing practice

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2
Q

Diff activities and processes we do in manufacturing firm to ensure the quality of out material s an equipment while they are being manufactured

A

Manufacturing control

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3
Q

How to handle raw material

A

Material control

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4
Q

Process of systematic examination of quality "official inspection" carried by an internal/ external quality auditor

A

Quality audit

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5
Q

Manufacturers need to do to begine the manufacturing co troll

A

Audit

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6
Q

Determine which steps in the production line have most impact on the quality and consistency of the final product

A

Risk analysis

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7
Q

Failure in audit

A

Published publicly and result in dismissal of qc certification

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8
Q

Need by industry to help control products from drug discovery through the manufacturing process

A

Data management approach

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9
Q

Assure product for release to help ensure the final product meet the companys quality criteria, process use to design test will be done correctly

A

Quality Assurance

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10
Q

Pahrmaceutical manufacturer challenges

A

Manufacturing
Pricing
Distribution
Drug discovery

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11
Q

Regulatory body of the Philippines

A

FDA

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12
Q

Effort of regulatory bodies try to allign what their requirements are

A

International conference on Harmonization

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13
Q

Basic document form where the master formula and batch production records are based

A

Manufacturing Monograph

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14
Q

Documents used in drug manufacture

A

Manufacturing Monograph
Master formula record/ master production Record
Batch Production Record
Quality Control Monograph
Standard operating procedures
In-process quality control

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15
Q

Contain standard for medical dosage forms drug substances excipient, biologicals, compounded preparation, medical device, dietary supplement and other therapeutics

A

USP-NF

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16
Q

Uses of standards of USP-NF

A

quality of medicine
Safety of patient

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17
Q

USP NF includes

A

Quality standards for medicine
API
Excipient

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18
Q

Aka: master batch record/ master manufacturing Formula

A

Master Formula Record/Master Production Record

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19
Q

One of the most important aspect of any manufacturing procedure

A

Consistency

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20
Q

Standards for satge 3 dissolution

A

Ave. 24 is nlt Q
2 tabs nlt Q-15
No tab nlt Q-25

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21
Q

Documents when, how, by whom with what tools and in what environment a product was produced

A

Batch production Record

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22
Q

Contents of BPR

A

Product formula
Manufacturing procedures
Production record
Raw material records
Packaging material record
Product experience reports

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23
Q

All ingredients include amount

A

Product formula

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24
Q

All steps in all stages of MP like sifting lubricating milling coating

A

Manufacturing procedures

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25
Q

Processing batch record

A

Production record

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26
Q

All. Info regarding active pharmaceutical ingredients and excipient

A

Raw material records

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27
Q

List of packaging material with quantity

A

Packaging material record

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28
Q

History of each batch of product

A

Product experience reports

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29
Q

Specific amount produced in a unit of time
Produced by one manufacturing order during same cycle

A

Batch

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30
Q

Specified portion of a batch having uniform character and quality w/in specified limits

A

Lot

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31
Q

Combination of markings, letters by which the history of a manufacture and control of a batch or lot can be determined

A

Batch number Lot number Control number

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32
Q

Letteres and numbers identified on the label

A

Control codes

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33
Q

Written document that reflects the quantity attributes of medicine approved by FDA

To guarantee product quality

A

Quality control monograph

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34
Q

Articulate quality expectations for a medicine or identity and security and Performance

Describe test to validate that medicine or drug and its ingredients meet criteria

A

Monograph

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35
Q

Rely on precision rigor and consistency to produce quality products to arrive the kind of culture that consistently and effectively produces result of nature

A

Pharmaceutical manufacturer

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36
Q

Generated to explain in detail the reason behind a procedure and proper sequence to be done and how an equipment is to be operated for maximum performance

A

Standard operating procedures

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37
Q

Set of written instructions document a routine or repetitive activity that is followed by the employees

A

SOP

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38
Q

Provide information to perform a job properly and consistently to achieve prederetmined specs and a quality end result

A

SOP

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39
Q

Test to control before manufacturing process completed to ensure products quality is meet before they approve for consumption

A

IPQC

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40
Q

Tets performed to determine if the product meets specifications through out the entire processing period

A

In-process Quality Control

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41
Q

Purpose is to determine any out or range measurement cann be corrected before further processing is continued

A

IPQC

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42
Q

Control tests is grouped into

A

Solid
Liquid
Semi solid
Lyophilized
Aerosol

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43
Q

Condected to sarisfy product identity, strength, purity and performance and safety
Some are performed during processing and repeated in final product

A

Control test

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44
Q

Test to identify that particular substance is medicine that it claims to be

A

Identify

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45
Q

Testing method and accepted ranges for the potency of a medicine/drug as fda approval

A

Strength

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46
Q

Information on impurities

A

Purity

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47
Q

Preduct and demonstrate how a medicine will be released as it enters the human body

A

Performance

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48
Q

Preparation for tablets, capsules, powders cakes, sticks

A

Solid prep.

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49
Q

Measured by ruler or vernier caliper

A

Thickness

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50
Q

Particle scattering technique

A

Sieving

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51
Q

# of linear opening per square inch

A

Mesh #

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52
Q

Retained mesh#20

A

Coarse granules

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53
Q

Pass #20, retained in #40

A

Good granules

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54
Q

Pass #20 and 40

A

Fine granules

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55
Q

Flow characteristics

A

Angle of repose

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56
Q

<25 Angle of repost

A

Excellent

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57
Q

25-30 angle of repose

A

Good

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58
Q

30-40 angle of repose

A

Fair ( add glidant)

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59
Q

>40 angle of repose

A

Poor

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60
Q

Static angle of repose

A

Fixed funnel method
Fixed bed cone
Tilting box

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61
Q

Methods of angle of repose

A

Static and kinetic

62
Q

Untapped volume also known as

A

Bulk volume

63
Q

Ratio of the mass of untapped powder

A

Bulk density

64
Q

Decrease bulk density after tapped

A

Tapped density

65
Q

Other name or carr's index

A

Compressibility index

66
Q

Excellent Carr's index

A

5-13

67
Q

Good Carr's index

A

12-16

68
Q

Fair to passable Carr's index

A

18-21

69
Q

Very fluid Carr's index

A

23-28

70
Q

Fluid cohesive Carr's index

A

28-35

71
Q

Extremely poor, cohesive Carr's index

A

> 40

72
Q

Good Hausner's ratio

A

<1.25

73
Q

Poor Hausner's ratio

A

> 1.25

74
Q

Fair to passable Hausner's ratio

A

1.25-1.5

75
Q

High air space

A

High compressibility

76
Q

Determining the air spaces

A

Porosity

77
Q

High moisture

A

Sticking and picking

78
Q

Low moisture

A

Capping
chipping
Lamination

79
Q

Done through microscopic evaluation

A

Shape of the granules and powders

80
Q

Hardness equipments

A

Stokes monsanto - spring
Strong cobb - air pump
Pfizer - pliers
Erweka- susp weight
Schleuniger - horizontal

81
Q

Caused by certain mechanical shock because of materila from intact tablets

A

Surface erosion

82
Q

Other name of powder fineness

A

Sieve analysis/ particle size analysis

83
Q

Common problems in all manufacturing firm dur to spoilage of active ingredient

A

Microbial contamination

84
Q

Minimum test that Need microbial testing

A

Microbial burden

85
Q

Causes static build up that cause static charges that dry out the medication affecting the intended behavior

A

Low humidity

86
Q

Cause the product to dry out or crumble or stick together

A

Excess static

87
Q

Cause the product to absorb excess moisture in the air w/c low comodity

A

High humidity

88
Q

Rate limiting test in absorption of the drug

A

Dissolution

89
Q

Ability of product to breakdown in small particles or granules

A

Disintegration

90
Q

Mixture of active drug and non- drug component and exipient dissolve in suitable solvents or mixtures of solvents

A

Liquid preparations

91
Q

Size enlargement process in w/c primary particles clump together to form bigger mass or aglomerate

A

Agglomeration

92
Q

Particles immediately set at the bottom part of the container

A

Suspendibility

93
Q

Suspended particles of active ingredient should readily redispersed

A

Redispersibility

94
Q

Resistance to flow

A

Viscosity

95
Q

More than 0.9 of NaCl

A

Hypertonicity

96
Q

Less than 0.9% NaCl

A

Hypotonicity

97
Q

Instrument in refractive index

A

Refractometer

98
Q

Purity determination with direct measurement of liquid measurement based on the refraction of light

A

Refractive index

99
Q

Physical property of surface of liquid to resist an external coarse

A

Surface tension

100
Q

Fever producing microorganisms

A

Pyrogen

101
Q

Key for GMO for safe use

A

Sterility testing

102
Q

Dye use in leak test

A

Methylene blue dye - Destructive methylene blue test

103
Q

These products are applied topically to steam of mucus membrane such as the eye or face, buccal, nasal mucosa, rectal and vaginal tissues

A

Semi solid prep.

104
Q

Test for suppositories

A

Softening range

105
Q

State of all of the same kind

A

Homogeneity

106
Q

Loss of weight of semi solid drug

A

Loss of water

107
Q

Freeze drying

A

Lyophilized

108
Q

Process w/c water is removed from the product after it is frozen and placed in a vacuum allowing ice to change directly from solid vapor w/o passing through a liquid phase

A

Freeze drying

109
Q

Fast or slow the lyophilized product is dissolved

A

Rate of solution

110
Q

Powder tending to form lumps or masses

A

Caking

111
Q

Amount of consumable product

A

Net content

112
Q

Enough pressure in the package that help product to come out to container

A

Pressure measurement

113
Q

Compressed gas inside container in w/c product active ingredient are dispersed

A

Propellant

114
Q

Part of package tru w/c product concentrate is expelled in the desired form and rate

A

Valve

115
Q

Df composed of a solid or mixture of solids reduced to a finely divided state and intended for internal or external use

A

Powders

116
Q

Df composed of dry aggregates of powder particles that may contain one or more APIs w/ or w/o other ingredients

A

Granules

117
Q

Granules mesh sieve size range

A

4-12 mesh sieve size range

118
Q

The sieves are arranged in nest with the ___ at the top

A

Coarsest

119
Q

Maximus angle possible between the surface of a pile of the powder and horizontal planes

A

Angle of repose

120
Q

Low angle or repose

A

Better flow property

121
Q

Rough and irregular surface

A

higher angle of repose

122
Q

Ratio of the mass of untapped powder sample and volume including the contribution of iner particulate void volume

A

Bulk density

123
Q

Increased bulk density attained after tapping

A

Tapped density

124
Q

Density formula

A

D=M/V

125
Q

Angle of repose formula

A

∅= Tan-1 (h/r)

126
Q

Demostrate the relationship bet. The flow and compressibility of powder

A

Carr's index/ compressibility index

127
Q

Formula for Carr's index

A

CI = TD-BD/TD x 100

128
Q

Preducts the flow property of powder by using inter particle friction

A

Hausner's ratio

129
Q

HR formula

A

HR= TD/BD

130
Q

Determine how many air spaces there are in a powder

A

Porosity

131
Q

High porosity

A

High compressibility

132
Q

True volume of porosity foluma

A

D=M/V

133
Q

Void formula for porositty

A

Void = BV-TV / BV

134
Q

Percentage of total volume in porosity

A

Void

135
Q

Karl Fisher method

A

Method 1

136
Q

Method 2

A

Azeotropic Distillation/Xylene/toluene method

137
Q

Gravimetric method

A

Method 3

138
Q

Prevents pyridine sulfur complex

A

Anhydrous methanol

139
Q

Prevents reversal of action

A

Pyridine

140
Q

Solvents in method 2 MC

A

Xylene and toluene

141
Q

Used for vegetable drugs
Biologics
Crude drugs

A

Method 3

142
Q

1k in N

A

9.807 newtons

143
Q

1kg in G

A

1000 G

144
Q

Basket apparatus

A

Type 1

145
Q

Tyep 2

A

Paddle apparatus

146
Q

Type 3

A

Reciprocating cylinder

147
Q

Type 4

A

Flow through cell apparatus

148
Q

Cylinder aparatus type

A

Type 6

149
Q

Paddle over disk

A

Type 5

150
Q

Reciprocating holder

A

Tyep 7

Qc Lec (2 decks)

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