QA/QC (Chapter V) Flashcards
(161 cards)
1
Q
• Determines tablet durability
• Primary importance: no capping or chipping
A
FRIABILITY
2
Q
FRIABILITY Sample:
Take a sample corresponding to 6.5g
A
≤ 650mg
3
Q
FRIABILITY Sample:
10 whole tabs
A
> 650mg
4
Q
FRIABILITY Equipment
A
Roche Friabilitor
5
Q
FRIABILITY Acceptance Criteria (max wt. loss):
≤ 1%
A
Old formulation
6
Q
FRIABILITY Acceptance Criteria (max wt. loss):
≤ 0.8%
A
New formulation
7
Q
• Ensures tablets meet specifications for potency
• Problems:
o Uneven distribution of API in powder mix/ granulation
o Segregation of powder mix/ granulation
o Tab wt. variation
A
DOSAGE UNIT UNIFORMITY
8
Q
• ≥ 25mg API per dose and comprising ≥ 25mg by wt. of dosage unit
• Sample: ____ uncoated compressed tablets
A
Weight Variation;
20
9
Q
• Ensures formulation potency
• <25mg API per dose and comprising <25% by wt. of dosage unit
• Sample: ____ units (assay individually); 20 units on retest
• Acceptance Criteria: ______
A
Content Uniformity;
10 units;
85-115% API
10
Q
Measure of the time required for a tablet to break up into small particles
A
DISINTEGRATION
11
Q
“State in which any residue of the unit, except fragments of insoluble coating or capsule shell,
remaining on the screen of the test apparatus is a soft mass having __________________”
A
Complete disintegration;
No palpably firm core
12
Q
Disintegration Test:
Basket - Rock Assembly
A
Equipment
13
Q
Disintegration Test:
37 ± 2° C
A
Media temperature
14
Q
Disintegration Test:
29-32
A
Cycles/minute
15
Q
Disintegration Test:
Water, simulated gastric fluid, simulated intestinal fluid
A
Media type
16
Q
Disintegration Test:
________ : wire mesh remains at least 15mm below fluid surface
________ : wire mesh descends nlt 25mm below the vessel
A
Fluid volume;
Upward stroke;
Downward stroke
17
Q
DISINTEGRATION Tablet type:
Medium: Distilled Water
Temp: 37 ±2 °C
Time: 30 min
A
Uncoated/IR tablet
Capsule
18
Q
DISINTEGRATION Tablet type:
Medium: Distilled Water
Temp: 37 ±2 °C
Time: 2-3 min
A
SL tablet
19
Q
DISINTEGRATION Tablet type:
Medium: Distilled Water
Temp: 37 ±2 °C
Time: 4 hrs
A
Buccal tablet
20
Q
DISINTEGRATION Tablet type:
Medium: Distilled Water
Temp: 37 ±2 °C
Time: 5 min (no disintegration)
A
Enteric coated tablet
21
Q
DISINTEGRATION Tablet type:
Medium: ___________, __________ (small intestine 6.8 ppt)
Temp: 37 ±2 °C
Time: 1hr (no disintegration), 1hr (v)
A
Enteric coated tablet;
Simdated gastric fluid,
Simulated intestinal fluid
22
Q
DISINTEGRATION Sample initial units
A
6 units
23
Q
DISINTEGRATION Stages:
Sample: 6
Acceptance Criteria: Disintegrate ALL, if 1-2 did not disintegrate -> S2
A
Stage 1
24
Q
DISINTEGRATION Stages:
Sample: if 12 units = 18
Acceptance Criteria: NMT 2/18 failed to disintegrate, Pass: ≥16 dis.
A
Stage 2
25
• Test for measuring the amount of time required for a given % of drug substance in a tablet to go into solution
• Temperature:
DISSOLUTION;
37 ±0.5 °C
26
DISSOLUTION Accessory:
TDDS
Type V-VII
27
DISSOLUTION Accessory:
Reciprocating holder
Type VII
28
DISSOLUTION Accessory:
Revolving cylinder
Type VI
29
DISSOLUTION Accessory:
Paddle over disk
Type V
30
DISSOLUTION Accessory:
Flow-through cell
Type IV
31
DISSOLUTION Accessory:
Reciprocating cylinder
Type lll
32
DISSOLUTION Accessory:
Paddle (50 rpm)
Type ll
33
DISSOLUTION Accessory:
Basket (100 rpm)
Type l
34
amount of dissolved active ingredients
Tolerance (Q)
35
DISSOLUTION
No. Tested: 6 units
AC: each units is NLT Q +5%
Stage l
36
DISSOLUTION
No. Tested: +6 (12)
AC: Ave (12) is nlt Q 75%
No unit
Stage ll
37
DISSOLUTION
No. Tested: +12 (24)
AC: Ave (24) is NLT Q 75%
Nmt 2 units
Stage lll
38
Vessel 1 % LC
86%
39
Vessel 2 % LC
83%
40
Vessel 3 % LC
85%
41
Vessel 4 % LC
86%
42
Vessel 5 % LC
87%
43
Vessel 6 % LC
85%
44
The goal of in vitro dissolution testing is to provide insofar as is possible a reasonable prediction of or correlation with the product's in vivo bioavailability.
IVIV Correlation Test
45
Class 1 IVIV Correlation Test:
Solubility & Permeability
Increase, Increase
46
Class 2 IVIV Correlation Test:
Solubility & Permeability
Decrease, Increase
47
Class 3 IVIV Correlation Test:
Solubility & Permeability
Increase, Decrease
48
Class 4 IVIV Correlation Test:
Solubility & Permeability
Decrease, Decrease
49
BCS-based biowaver
Class 1&3
50
It is measure of cohesive strength of the cross-linking that occur between gelatin molecules, and it gives an indicator of the firmness of the gel.
BLOOM STRENGTH
51
Determined by measuring the weight in g required to move a standard plunger that is 0.5 inches in diameter, a fixed distance of 4 mm deep into 6.66% W/V gel held at 10 ℃ for 17-18 hours.
BLOOM STRENGTH
52
Bloom strength in the range of ______________ is considered suitable for capsule.
150 to 250g
53
MICROBIAL CONTENT:
Plant, animal and mineral preparations absence of
Salmonella spp.
54
MICROBIAL CONTENT:
Absence of P.aeruginosa, E.coli, Salmonella spp.
Oral preparation
55
MICROBIAL CONTENT:
Sterile
Ophthalmic
56
MICROBIAL CONTENT:
Absence of P.aeruginosa, & S.aureus
Topical preparations
57
MICROBIAL CONTENT::
Urethral, Rectal, Vaginal absence of
molds & yeasts
58
MICROBIAL CONTENT
Medium:
Tryptone Soya Broth
Soybean-Casein Digest Broth
Tryptone Soya Agar
Soybean-Casein Agar
Tryptic Soy Agar
30 to 35°C for ____ hours
Total Aerobic Count;
18 to 24
59
MICROBIAL CONTENT
Medium:
Potato Dextrose Agar/Broth Saboraud Dextrose Agar/Broth
20 to 25°C for ______
Total Combined Yeast and Mold Count;
2 to 3 days
60
• For semisolids with labeled content of nmt 150g or 150ml
• Sample: 10 containers (assay individually); 20 containers on retest
MINIMUM FILL
61
container with sample
Initial wt.
62
empty container (heated at ______________ then cooled)
Final wt.;
100 °C x 5mins
63
Acceptance Criteria for Each container:
<60g or 60ml: >90%
≥60g or 60ml (but nmt 150g or 150ml): >95%
Aerosols
64
Acceptance Criteria for Each container:
Net content > labeled content
Non-Aerosols
65
• Sample: 10 tubes (extrude contents in peri dish)
• Heat @ 85°C for 2 hours the cool
• _______ → count metal particles using microscope (≥ 50 μm)
Metal particle in Ophthalmic ointments;
Invert Petri dish
66
must pass sterility test
Single use
67
must pass antimicrobial effectiveness test
Multiple use
68
• Applicable for liquid products nmt 250mL
• Sample size: 10 containers; __ containers on retest
• Procedure: (Angle: ___°; prevent air-bubble formation)
Deliverable volume;
20 containers;
30 °
69
Deliverable volume:
Drain in 5 seconds
Single unit
70
Deliverable volume:
drain in ≤30 mins
Multiple unit
71
Free for all particle velocity on Andreasen pipet based on Stokes law
Sedimentation rate (F)
72
Sedimentation rate (F) Particle size:
0.1 - 1nm
Solution
73
Sedimentation rate (F) Particle size:
1 - 100 nm
Colloidal
74
Sedimentation rate (F) Particle size:
>100 nm
Suspension
75
Ratio of the height of sediment settled after standard condition and with the initial height of the suspension
SEDIMENTATION VOLUME
76
settled volume unit of sedimentation volume
Vu
77
suspension volume unit of sedimentation volume
Vo
78
Particles: larger, loose aggregates uniform
Flocculated
79
FLOCCULATED Sedimentation rate and volume
High
80
DEFLOCCULATED Sedimentation rate and volume
Low
81
FLOCCULATED Supernatant
Clear
82
DEFLOCCULATED Supernatant
Turbid
83
FLOCCULATED Sediment
Porous “loosely packed”
Rapidly formed
83
DEFLOCCULATED Sediment
Non-porous (hard cake) “tightly packed “
Slowly formed
84
Particles: smaller, individual particle varying
Deflocculated
85
FLOCCULATED Appearance
Not elegant/ pleasing
86
DEFLOCCULATED Appearance
Elegant/pleasing
86
FLOCCULATED Redispersibility
Yes;
Less stable
87
FPCQ TEST FOR SUSPENSIONS
Ideal: 100% with minimum agitation
REDISPERSIBILITY
88
DEFLOCCULATED Redispersibility
No;
More stable
88
FPCQ TEST FOR SUSPENSIONS
Measure of resistance to flow & should not be too fluid nor too viscous
RHEOLOGICAL PROPERTIES: VISCOSITY
89
FPCQ TEST FOR SUSPENSIONS
• Repulsive forces between particles
ZETA POTENTIAL
90
• __ zeta potential = __ Settling = __ stability
Increase;
Decrease;
Increase
91
FPCQ TEST FOR SUSPENSIONS
• T: 40 °C
• Centrifugation: ______________
TEMPERATURE AND GRAVITATIONAL STRESS;
Crystal growth
92
Single point viscometers:
Capillary viscometer
Ostwold (most common)
93
Single point viscometers:
Falling sphere viscometer
Hoeppler
94
Multiple point viscometer:
Cup is rotating
Couette
95
Multiple point viscometer:
Bob is rotating
Searle
96
Multiple point viscometer:
Cone and plate
Ferranti-shirley viscometer
97
Determines the viscosity by measuring the resistance on a shaft rotating in the fluid.
Pointer displacement is _________ proportional to fluid viscosity.
Viscosity Test;
Brookfield viscometer;
Directly
98
EMULSION TYPE TEST/DILUTION TEST:
Dye Solubility
W/O: _______
O/W: ________ & _______
W/O: Sudan red
O/W: Amaranth green & Methyl red
99
EMULSION TYPE TEST/DILUTION TEST:
UV fluorescence
W/O: _______
O/W: ________
W/O: Yes
O/W: No
100
EMULSION TYPE TEST/DILUTION TEST:
Conductivity
W/O: _______
O/W: ________
W/O: No
O/W: Yes
101
EMULSION TYPE TEST/DILUTION TEST:
Cobalt chloride
W/O: _______
O/W: ________
W/O: Blue
O/W: Pink
102
FPCQ TEST FOR SUSPENSIONS
• Creaming
• Cracking/breaking
• Phase separation/inversion
INSTABILITY TEST
103
FPCQ TEST FOR SUSPENSIONS
• T: 50-70°C
TEMPERATURE AND GRAVITATIONAL STRESS
104
STERILITY (Sterilization Test)
Incubation: 7 days
Notes: Primary
Membrane filtration technique
105
STERILITY (Sterilization Test)
Incubation: _____________ (20-25°C; 5-7days)
Notes: __________ (e.g., fungi: total yeast
and molds count)
Direct inoculation;
Soybean casein digest medium;
Aerobes
106
STERILITY (Sterilization Test)
Incubation: _____________ (30-35°C; 2-3days)
Notes: __________ (also used in total aerobic count)
Direct inoculation;
Fluid thioglycolate medium;
Anaerobes
107
STERILITY (Sterilization Test)
Notes: Preferred for sterilizations processes
Biological Indicator
108
Biological indicator of:
Steam/ moist heat
Bacillus stearothermophilus
109
Biological indicator of:
Dry heat
B. subtilis
110
Biological indicator of:
Ethylene oxide
B. subtilis
111
Biological indicator of:
Sterilizing membrane filter
P. diminuta
112
Biological indicator of:
Ionizing radiation
B. pamilus
113
Organic metabolic products from G (-) bacteria which can cause fever and hypotension
Thermostable (non-autoclave)
PYROGENS/BACTERIAL ENDOTOXINS
114
Pyrogen Test:
a) Bacterial endotoxin/ Limulus Amebocyte Lysate test (______)
b) Rabbit test (______)
a. in vitro
b. in vivo
115
• LAL source: ___________
• Detect and quantify endotoxin from gram-negative bacteria
Bacterial Endotoxin Test (BET) / Limulus Amebocyte Lysate test (in vitro);
Horseshoe crab “Limulus Polyphemus”
116
to test the integrity of the gel, take each tube in turn directly from the incubator and invert it through about 180deg in one smooth motion.
Gel-clot
117
Positive technique of Bacterial Endotoxin Test (BET)/ Limulus Amebocyte Lysate test (in vitro)
Firm gel
118
Negative technique of Bacterial Endotoxin Test (BET)/ Limulus Amebocyte Lysate test (in vitro)
No gel
119
Bacterial Endotoxin Test (BET)/ Limulus Amebocyte Lysate test (in vitro)
(+) positive turbidity technique
Tubidimetric
120
Bacterial Endotoxin Test (BET)/ Limulus Amebocyte Lysate test (in vitro)
(+) positive colored solution technique
Chromogenic
121
Rabbit test:
Samples: 3 healthy, mature rabbits (37±2 °C)
Apparatus: Depyrogenated at 250°C
Prior Test
122
Rabbit test:
Inj. 10mL/kg TS in the ear vein
After 1 hour, record the rectal temperature (30 mins
intervals for 3 hours)
During Test
123
Rabbit test:
Sum rise:
AC 1: <1.5°C for 3 rabbits (provided NO individual
rise of ≥0.5°C + 5 rabbits
AC 2: ≤3.3°C for 8 rabbits (provided NMT 3 rabbits
have individual rise of ≥0.5°C
AC (Non-pyrogenic)
124
Pyrogen test in 8 rabbits
Temp Rise (°C) of Rabbit #1
0.2
125
Pyrogen test in 8 rabbits
Temp Rise (°C) of Rabbit #2
0.6
126
Pyrogen test in 8 rabbits
Temp Rise (°C) of Rabbit #3
0.3
127
Pyrogen test in 8 rabbits
Temp Rise (°C) of Rabbit #4
0.5
128
Pyrogen test in 8 rabbits
Temp Rise (°C) of Rabbit #5
0.1
129
Pyrogen test in 8 rabbits
Temp Rise (°C) of Rabbit #6
0.2
130
Pyrogen test in 8 rabbits
Temp Rise (°C) of Rabbit #7
0.2
131
Pyrogen test in 8 rabbits
Temp Rise (°C) of Rabbit #8
0.4
132
Did the individual temp rise of each rabbit comply with the requirement?
Yes. NMT 3 rabbits >0.5 °C
133
Did the temp rise comply with the requirement?
Yes
134
What test in FPCQ:
Bioassays
Safety/ Cytotoxicity Test
135
What test in FPCQ:
• Visual inspection
• Inverted to see heavy particles
Clarity Test
136
What test in FPCQ:
• Negative pressure within incompletely sealed ampule while submerged in dye solution
• Ampules with color contents → ______
Leaker’s test;
Discarded
Leaker’s test (methylene blue “methyleak”)
137
What test in FPCQ:
• Presence of extraneous mobile undissolved particles
• Must be carried out in ________________
Particulate matter;
Laminar airflow hood
138
What method:
Light obscuration particle count test
• Adv: _______
• Disadv: for clear & non-viscous solution
Method I;
Automatic
139
What method:
Microscopic particle count test
• Uses microscope with ocular micrometer, membrane filter and illuminators
Method ll
140
Test to determine the viable and nonviable particles suspended in air or settled on surfaces
ENVIRONMENTAL CONTROL TEST FOR STERILE AREAS
141
Methods:
• Agar plate exposure to the settling air microbes
• Rodac plates
Air sampling (Slit-to-agar-sampler)
142
• Evaluates the environment along with the process, operators and equipment
• Sterile trypticase soy broth is filled into at least 3000 sterile containers → incubated at 20-25°C for 14days → examined for bacterial growth
• Acceptance Criteria: __________ of units is (+) for growth
Media fill (process simulation testing);
NMT 0.1%
143
• Determines particle size by means of shadow casted by particles as it passes through a high intensity beam
• Disadv: ________
Electronic/ automated particle counter;
Non-specific
144
Electronic/ automated particle counter:
Counter counter
Electrical resistance
145
Electronic/ automated particle counter:
Gelman counter
Tyndall effect
146
Electronic/ automated particle counter:
Hiac/ Royco
Light blockage
147
• Collects particles size greater than the membrane pore size
• Disadv: _______, _______
Membrane filtration technique;
Saturable, slow counting
148
• Efficiency tests:
• DOP (________) test
• Test HC (_______) emery test
HEPA Filter;
dioctyl phthalate;
Henkel corp
149
measures the force required to peel away a transdermal patch attached to a stainless steel test panel substrate at panel angles of 90° or 180° following a dwell time of 1 min and peel rate of
300 mm/min.
PEEL ADHESION TEST
150
• measure the tack adhesive properties of TDS dosage forms.
• With this test a probe touches the adhesive surface with light pressure, and the force required to break the adhesion after a brief period of contact is measured.
TACK TEST
151
• measure of the cohesive strength of TDS dosage forms
• Two types of shear testing are performed
SHEAR STRENGTH or CREEP COMPLIANCE TEST
152
During ________ testing the TDS is pulled from the test panel at a constant rate.
dynamic
153
With the ________ test, the TDS is subjected to a shearing force by means of a suspended weight.
static
154
What USP Dissolution Apparatus is not accepted by the Japanese Pharmacopeia?
A. Apparatus 1
B. Apparatus 2
C. Apparatus 3
D. Apparatus 4
C. Apparatus 3
155
Which of the following is used for Leaker’s test?
• A. Eriochrome black T
• B. Amaranth red
• C. Methylene blue
• D. Malachite green
C. Methylene blue
156
Which of the following containers can use a type 4 glass?
• A. Vial
• B. Ampoule
• C. Glass bottle
• D. Glass syringe
• E. None of the above
C. Glass bottle
157
Area equipped with HEPA filters are required for testing of the efficiency of the filters through the use of which of the following?
A. Dioctyl phthalate test
B. Water attack test
C. Pyrogen test
D. Bubble point test
A. Dioctyl phthalate test
158
What is HEPA
High Efficiency Particulate Air;
99.97%
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