QC 1 Flashcards
(282 cards)
1
Q
It refers to the totality or conformance to specification of a product
A
Quality
2
Q
A list of detailed requirements with which a product has to conform (tests, references of procedures, and acceptance criteria)
A
Specification
3
Q
Sum total of the organized activities made with the objective of ensuring that products are of quality required for intended use
A
Quality Assurance
4
Q
Part of QA which ensures that products are consistently produced & controlled to quality standards appropriate to intended use
A
Current Good Manufacturing Practice
5
Q
cGMP AO
old AO ______________
new AO _____________
A
AO 220 s. 1974
AO 212 s. 0008
6
Q
PIC/S:
A
Pharmaceutical Inspection Cooperation Scheme
7
Q
Part of cGMP concerned with sampling, specification, testing, organization, documentation, and release procedures
A
Quality control
8
Q
It is the linkage between written records of action taken and the quality operation
A
Documentation
9
Q
All the tests to be conducted on a product and raw materials and/or appropriate references containing DETAILS OF PROCEDURE and EXPECTED RESULTS vs ACTUAL RESULTS
A
Documentation
10
Q
regular periodic quality review of all registered drug products to verify consistency of existing process and to identify improvements
CAPA _________________
A
Product Quality Review
Corrective and Prventive Action
11
Q
systematic process for the assessment, control, communication, and review of risks to the quality of the product
A
Quality Risk Management
12
Q
combination of probability of the occurrence of harm and the severity of harm
A
Risk
13
Q
A set of activities that ensures quality in the process by which the products are developed.
A
Quality assurance
14
Q
A set of activities that ensures quality in the product
A
quality control
15
Q
Aims to prevent defects in the process used to make the products
A
quality assurance
16
Q
Aims to identify and correct defects in the finished product
A
quality control
17
Q
- Audit and monitoring
- Primary contact with regulatory agencies
- Prepares SOPs
A
Quality Assurance
18
Q
- Conducts sampling and testing of RM & FP
- Inspects PM components
- Performs environmental monitoring
A
Quality control
19
Q
process oriented ________
product oriented ________
A
QA
QC
20
Q
What are the 3 main areas of QC?
A
Raw material QC
In-process material QC
Finished Product QC
21
Q
testing the quality of bulk ingredients and containers
A
Raw Material QC (RMQC)
22
Q
testing the quality of intermediate products (e.g. granules prior
tablet compression)
A
In-process Material QC
23
Q
testing the final dosage form in its container
A
Finished Product QC (FPQC)
24
Q
- Written standard published in compendium (USP/BP/Eur/PP) that describes an article
- Quality attributes approved by a regulatory body
- Name of substance, definition, packaging & storage requirements
- Information on all tasks and expected results needed to ensure its quality
A
Monograph
25
Step-by-step instruction for doing a particular task or activity
SOP (Standard Operating Procedure)
26
* Shows the actual results of all tests conducted to show compliance with standards
* Describes the tests conducted on a particular material, along with the acceptable criteria, results, and disposition
Certificate of Analysis
27
* Information on potential health effects of exposure and safe working procedures when handling
* Properties of a particular hazardous substance or chemical.
Material Safety Data Sheet (MSDS)
28
* Process of removal of an appropriate number of items (n) from a population (N) in order to make an inference to the entire population
SAMPLING
29
what military standard sampling plan is most commonly used?
MIL-STD-105E
30
what military standard sampling plan is used by variable (inspection)?
MIL-STD-144
31
new and most common sampling plan
ANSI/ASQ ZI.4-2008
32
100% inspection may be allowed for ______________ medications
high risk
33
A definite working rule regarding size and frequency of sample and the basis for acceptance and rejection
Sampling Plan
34
Graphs on which the quality of product is plotted as manufacturing is actually proceeding
Control Charts
35
a type of control chart used when n is not always constant, refered to as proprotion or percent of defectives, and is versatile
p-chart
36
type of control chart used when n is always contant, non proportional and number of defectives
np-chart
37
control chart used for measurable characteristics
X Bar Chart
38
alerts the operator to closely monitor the process (2 sigma / std dev)
warning limit
39
stop the process and do corrective actions (3 sigma or std dev)
Action or Control Limit
40
proving & documenting that any process, procedure, or method actually leads to the expected results.
validation
41
proving that premises, systems, or equipment work correctly and actually lead to expected results.
qualification
42
Types of Data:
__________ - continuous data (tempt or pressure )
__________ - whole (pass or fail)
Variable
Attribute
43
a varaiation wherein the quality between supplier 1 and 2 are not the same
material
44
source of variation wherein some parts of the equipment are not well-maintained
machine
45
source of variation whreien the working instruction is written in jargon
method
46
source of variation ": overfatigue, lacking PPE"
man
47
Non-conformance to a standard or requirement
Product defects
48
Defects according to magnitude
critical
major
minor
49
may endanger the life of patient and render the product non-functional
critical defect
50
may affect the function of product and render it useless
major defect
51
neither; discoloration, labels
minor defect
52
defects according to measurability
variable
attribute
53
defect measured by instrument
variable defect
54
defect by inspection (senses)
attribute
55
defects according to nature
ocular
internal
performance
56
defect seen by the naked eye
ocular defect
57
defect cannot be seen by naked eye (eg. Concentration)
internal defect
58
function is incorrect (MDI, dissol.)
performance defect
59
Removal from market; either defective/ potentially harmful
product recall
60
product recall caused by death or serious ADR
CLASS 1
61
product recall caused by temporary or medically reversible ADR
CLASS 2
62
PRODUCT RECALL CAUSED BY A NOT LIKELY TO CAUSE SERIOUS ADR
CLASS 3
63
capacity of a drug to remain within specification
STABILITY
64
minimum acceptable potency is?
90%
65
this is prevented by reduction or elimination of water from preparation
hydrolysis
66
this is prevented by Vitamin E (antioxidants)
Oxidation
67
prevented by using light resistant containers
Photolysis
68
* Period of time during a product remains within specification
* Estimated using __________ equation
shelf life
Arrhenius
69
* Time or date prior to which a product is expected to remain stable & after which it must not be used
formula : _______________
expiration date
Exp Date = Mfg Date + Shelf-life
70
risk of rejecting a true null hypothesis
an inspection/test may indicate that a product or process is defective when it is actually acceptabe
harms the ______
ex __________
alpha risk, type 1 error
company
too early expiration date
71
risk of accepting a false null hypothesis
an inspectio/test may indicate that a product or process is acceptable when it is actually defective
harms the ______________
It can be reduced by increasing the sample size or improving the accuracy of the measurement tool.
ex _________________
beta risk, aka type 2 error
patient
too late expiry date
72
* Estimate shelf-life
* Evaluated over time in the same container-closure system in which drug product is marketed.
* Based on ASEAN Guidelines on Stability Studies
STABILITY STUDIES
73
Conducted inder normal conditions
Follow _______ kinetics
Testing period ________________
Long Term/Real Time studies
zero order
0,3,6,9,12,18,24,36
74
* Designed to increase rate of chemical degradation by using exagerated storage conditions
* Follow __________ kinetics
* Testing Period: ______________
Short Term/Accelerated studies
first order
3,6,9
75
Elucidates intrinsic stability of drug & identify the likely degradation products
stress testing
76
Long Term (Real Time)
Storage Condition __________
Minimum Time Period ________
Testing Frequency ___________
25 ± 2 deg c ; 60 ± 5% RH
12 mos
0,3,6,9,12,18,24,36
77
Intermediate stability studies
Storage Condition __________
Minimum Time Period ________
Testing Frequency ___________
30 ± 2 deg c ; 60 or 65 ± 5% RH
6 mos
0,3,6
78
Accelerated stability studies
Storage Condition __________
Minimum Time Period ________
Testing Frequency ___________
40 ± 2 deg c ; 75 ± 5% RH
6 mons
0,3,6
79
Overages
___________ - compensate the loss
___________ - extend shelf life
manufacturing overages
stability overages
80
status of materials which are isolated physically while a decision is awaited on their release, rejection or reprocessing
quarantine
81
* All quarantine materials are labeled with __________ color
* Materials that conform to tests are labeled with __________ color
* Materials that are rejected are labeled with __________ color
yellow
green
red
82
Stocks brought in first are used first
FIFO (First in First Out)
83
Stocks expiring first are used first
FEFO (First Expiry First Out)
84
Starch + I2 in KI TS ---> ________
Color Reaction
Deep Blue
85
Chloride + AgNO3 TS --> __________
precipitation
white precipitate (AgCl)
86
Ammonium + NaOH TS ---> _____
Evolution of Gas
pungent odor
87
Determines the percentage purity or the potency of an API
ASSAY
88
3 types of chemical assay
titrimetry
gravimetry
instrumental
89
types of biologic assay
animal assay
microorganism assay
90
assay that measures volume
titrimetry
91
assay that measures weight or mass
gravimetry
92
Animal used for assay of Digitalis
Pigeon (Pigitalis)
93
Animal used for assay of Tubocurarine
Rabbit - Head Drop Assay
(Tubocurabbit)
94
Animal used for assay of insulin
rabbit (rabbinsulin)
95
Animal used for assay of glucagon
cat (gluCATgon)
96
Animal used for assay of corticotropin
rat (coRAT)
97
Animal used for assay of cod liver oil
rachitic rat (vit d defiecient)
98
Animal used for assay of chorionic gonadotropin
female rat
99
Animal used for assay of vasopressin
male rate (vasoRAT)
100
Animal used for assay of oxytocin
chicken (oxytoCHICK)
101
Animal used for assay of parathyroid hormone
DOG (paraDOG)
102
Animal used for assay of Heparin and protamine sulfate
Sheep (sheeparin)
103
o Uses cylinders or paper
discs on top of the
solidified nutrient
medium in a petri dish
o Based on diameter of
the _______________
Cylinder Plate Method
Zone of Inhibition
104
o Uses a test tube filled with fluid
nutrient medium, where the test
organism is inoculated
o Based on transmittance of light
Turbidimetric method
105
less turbid = _______ transmittance = _____ potent = no growth
increase transmittance
more potent
106
Test organism for Penicillin G
Staphyloccocus aureus
107
Test organism for Bacitracin
Micrococcus luteus
108
test organism for Streptomycin
Klebsiella pneumoniae
109
test organism for Chloramphenicol
Escherichia coli
110
test organism for vancomycin
Bacillus subtilis
111
test organism for nystatin b
Saccharomyces cerevisiae
112
test organism for niacin and Ca pantothenate
Lactobacillus plantarum
113
test organism for cyanocobalamin
Lactobacillus leichmannii
114
Measures small amounts of impurities in a RM
Limit Test
115
Types of Impurities:
1. ________: dirt or isnoluble matter
2. __________: microorganisms
3. _________ : byproduct, heavy metals, degradation products, reagents, catalysts, ligands, residual solvents
gross
biological
chemical
116
reagent used to test for heavy metal impurities
Hydrogen Sulfide TS --> black
117
reagent used to test for Arsenic
Silver diethyldithiocarbamate TS --> Red
118
reagent used to test for Iron
Ammonium Thiocyanate TS --> RED
119
reagent used to test for Chloride
Silver Nitrate --> white ppt.
120
reagent used to test for Sulfate
Barium Chloride TS --> white ppt.
121
reagent used to test for Lead
Ammonia cyanide soln TS
Thioacetamide TS
122
reagent used to test for Ca, Na, Cl
Flame Photometry
123
instrument used for Specific gravity
Pycnometer (official)
Mohr-westphal balance (non-official)
124
instrument used for Solubility tests
Dissolution in a suitable solvent
125
instrument used for Refractive Index
Abbe refractometer
126
instrument used for optical activity
polarimeter
127
instrument used for pH
glass electrode pH meter
128
instrument used for melting point
capillary tube
129
Ratio of density of substance to that of a reference substance at 25 °C
Specific gravity
130
specific gravity of water
1 at 4 deg c
131
sp. g of alcohol is measured using ____________ at __________ deg c
hydrometer
15.56 deg c (60 deg F)
132
Ratio of velocity of light in air to the velocity of light in the substance at 25°C
refractive index
133
Measure of ability to rotate an incident plane of polarized light
* May be ________________ or ________________
* Measured using ________________
Optical Rotation/Optical Activity
dextrorotatory or levorotatory
polarimeter
134
physical test that Indicates presence of impurities
BP-MP
135
Determines the amount of volatile matter driven off after drying
Loss on Drying (LOD)
136
In cases wherein H2O is the only volatile constituent
Water Determination
137
What are the official methods of Water Determination
Titrimetry
Azeotropic
Gravimetric
138
Based on the reaction of water with Karl-Fischer Reagent
Method I: Titrimetric/ Karl-Fischer Titrimetry
139
Karl Fischer Reagents
Sulfur dioxide
Iodine
Pyridine
Anhydrous methanol
140
KFR component that reacts with water
sulfur dioxide and iodine
141
KFR component that acts as a buffer and prevents reversal of rxn
pyridine
142
KFR component used as a solvent and prevents complexation
anhydrous methanol
143
standard for karl fischer titrimetry
sodium tartrate dihydrate
144
Types of Karl Fischer Titrimetry
* Method IA: _______
* Method IB: _______
* Method IC: ________
Direct
Residual
Coulometric
145
this water determination method is based on distillation of water with toluene, xylene, benzene
uses a toluene-moisture apparatus
Method II: Azeotropic/Toluene Distillation/Xylene Method
146
this water determination method is based on loss of drying
Method III: Gravimetric/Drying or Thermal Method
147
Temperature of Gravimetric
* Inorganic: _______
* Organic: _________
110 - 120 deg c
105 deg c
148
______________ is the very common packaging material that is used in pharmaceutical products. Its basic structural network is made of __________________.
Glass
Silicon oxide tetrahedron
149
2 Problems with Container:
1. Leaching ____________
2. Sorption ___________
container to drug
drug to container
150
Chemically resistant, low leachability, and low thermal coefficient of expansion
application ____________
chemical composition _____________
Type 1 - Highly Resistant Borosilicate Glass
all products and parenteral soln
Boric acid --> inert
Silicon dioxide --> inc resistance
151
type of glass used for acidic or neutral solutions
chemical composition ________
Type 2 - Treated Soda Lime Glass
Sulfur dioxide
152
what type of glass is used for dry powder for parenterals
chem composition __________
Type 3 - Soda Lime Glass
sulfur dioxide
153
Type of glass used for non-parenterals
Type 4 - General Soda Lime Glass
154
What are the 3 old USP tests for hydrolytic resistane for glass?
Powdered Glass Test
Water Attack test
Surface Glass test
155
Powdered Glass us used for _____
use:
Type 1 and 3 Glass
crushed glass
titrated w/ H2SO4
Type 1 : 1 ml
Type 3 : 8.5 ml
156
Water attack test is used for _______
use ___________
Type 2 Glass
intact glass
titrated w/ H2SO4
157
Surface Glass Test is used for __________
use __________
Type 1 and 3 Glass
intact
titrated w/ HCl
158
What are the 3 new USP tests for hydrolytic resistane for glass?
Glass Grains test
Surface Glass test
Surface Etching test
159
use of Glass Grains test
Type 1 from 2 and 3
160
Use of Surface Glass Test
Type 1 and 2 from type 3
161
use of Surface etching test
type 1 from 2
162
test used for colored glass containers
Limit: ________________ at any wavelength in the range of ________________
Light Transmission
NMT 10%
290 - 450 (UV-Vis)
163
*For Type __ or Type __ glass container
* Method: same with limit test for As
* Limit:
Arsenic test
Type 1 and 2
0.1 mcg/g
164
What are the tests for plastics?
Biological Reactivity Test In Vivo and In Vitro
165
Systemic Injection Test
Sample _______________
Animal used _____________
Parenteral containers
albino mice
166
Intracutaneous Test
Sample _______________
Animal used _____________
parenteral containers
albino rabbit
167
Eye irritation test
Sample _______________
Animal used _____________
Ophthalmic containers, medical devices
Albino rabbit
168
Implantation test
Sample _______________
Animal used _____________
material in direct contact w the tissues
rabbit
169
Agar Diffusion Test
Direct Contact Test
Elution Test
sample _________
test organism _____________
elastomeric material (plastic)
cell or tissue
170
2 tangents represented by longest distance
feret
171
bisect particles into halves
martin
172
circle diameter that will enclose the particle
projected area
173
advantage of optical microscopy
individual particles can be seen (most reliable)
174
disadvantage of optical microscopy
2d image only (tedious)
175
official and ideal method to measure particle size
sieving
176
apparatus for sieving analysis
set of sieves
177
advantage of sieving analysis
fastest, most efficient
178
disadavantage of sieving analysis
large sample size is needed (25 g)
not for oily and cohesive substances
179
Sieve or Mesh number definition
number of square opening per linear inch
180
inc sieve # = _______ particle size
decrease
181
#10 ___________
#100 __________
coarsest
finest
182
Sieving Methods:
a. ______________
* Sieve shaker
* For particles >75 μm
Mechanical agitation/dry sieving
183
Sieving Methods:
_______
* For particles < 75 μm
* Single sieve at a time
Air jet
184
______________
* For particles < 75 μm
* With vertically oscillating column of air (that lifts the specimen and then carries it back against mesh openings)
* Nest of sieves
sonic sifting
185
Endpoint of sieving
* Weight difference of ____
* If <5% of total wt. is present on any sieve, the endpoint for that sieve is increase to wt. change of ________
* If 50% of the sample is (+) in a sieve, repeat test but insert a _________ sieve
<5%
≤20%
coarser
186
retained at mesh 20
coarse granules
187
passed at mesh 20, retained at 40
good granule
188
passed mesh 40
fines/ fine granules
189
too much fines
softness and capping
190
not enough fines
decrease in tablet size during compression
191
Correct particle size also ensures the proper ___________ of the drug.
dissolution
192
percent of granules
good granules: __________
fine granules: _________
85-90%
10-15%
193
density defines as powder + spaces
bulk density
194
Bulk Density
Method I: __________
Method II: __________
Method III: ____________
graduated cylinder
scott volumeter
vessel
195
Tapped Density
Method I & II: _________
Method 3 : __________
graduated cylinder
200 + 400 taps
196
endpoint for tapped density
V500 - V1250 ≤ 2 mL
197
* Measure of ______________
* Maximum angle possible between the surface of the pile of powder and the horizontal plane
* 3D angle assumes by a cone-like pile of material
Angle of Repose
Flowability
198
Apparatus to measure angle of repose (static)
Funnel Method
Fixed bed cone
tilting
199
Apparatus to measure angle of repose (kinetic)
cylinder method
200
measure of compressibility
carr's index
201
* Flow rate (measured as mass per time flowing from any types of containers: cylinders, funnels, hoppers)
* For ____-flowing powders only
Flow through orifice
free-flowing
202
UNIFORMITY OF MIXTURES
Criteria: should contain __________ API
98-102% API
203
UNIFORMITY OF MIXTURES
Methods:
a. __________
b. ___________
c. ____________
Coning and Quartering
Thief Sampling
% purity
204
MOISTURE CONTENT
Sample: _______________
Criteria: _________________
Methods
granules prior to compression
NLT 0.5% to NMT 1% (0.5-1)
Gravimetric Mrthod
Ohaus Moisture Balance/Analyzer
205
Adhesion of granules to the die wall
sticking
206
Adhesion of granules to the punch
picking
207
Complete/partial separation of the top or bottom part of the tablet
capping
208
Separation of small portions of the tablet
chipping
209
Separation into two or more layers of the tablet
lamination
210
Ability to withstand mechanical shocks from handling in manufacturing, packaging and shipping
* ______________ : measures the mechanical integrity of the tablet. It is the breaking force required to cause them to fail.
* Affects ______________ and ______________
aka _______________
Tablet Hardness
Breaking Force
Disintegration and Dissolution
Crushing strength/Breaking Force
211
number of samples for tablet hardness
6
212
rule of thumb
crude method
213
stokes-monsanto
spring
214
strong cobb
air pump, hydraulic pressure
215
erweka
suspended weight
216
pfizer
pliers
217
schleuniger/heberlein
anvil, most commoly used, horizontal
218
Acceptance criteria of Ordinary compressed tablet
4-10 kg
219
Acceptance criteria of Buccal tbalet
7-10 kg
220
Acceptance criteria of chewable and sublingual tab
2-3 kg
221
Acceptance criteria of sustained release tab
10-20 kg
222
o Identical appearance
o Facilitate packaging
o Accuracy for tablet counting machines
Tablet thickness
223
apparatus for tablet thickness
micrometer caliper
vernier caliper
224
Acceptance criteria of tablet thickness
±5% of the set standard thickness
225
determines tabet durability
friability
226
primary importance of friability
no capping or chipping
227
Sample (Friability)
o ≤ 650mg:
o > 650mg:
take a sample corresponding to 6.5 g
10 whole tablets
228
Friability:
Equipment: ________________
Specification: ______________
Roche Friabilator
25 rpm x 4 mins = 100 revolutions
229
Friability Acceptance criteria (max wt. loss)
o Old formulation: ___________
o New formulation: _____________
≤ 1%
≤ 0.8%
230
Ensures tablets meet specifications for potency
dosage unit uniformity
231
Weight Variation
* _________API per dose and comprising _______by wt. of dosage unit
* Sample: ____ uncoated compressed tablets
≥ 25mg
≥ 25%
20 uncoated tablets
232
Accepatnce criteria for weight variation
average weight: <130 mg
±10%
No more than 2 tablets are outside this range, and none are beyond twice (±20%).
233
Accepatnce criteria for weight variation
average weight: 130-324 mg
±7.5%
No more than 2 tablets are outside this range, and none are beyond twice (±20%).
234
Accepatnce criteria for weight variation
average weight: >324 mg
±5%
No more than 2 tablets are outside this range, and none are beyond twice (+-15%).
235
*Ensures formulation potency
* ______mg API per dose and comprising ______ by wt. of dosage unit
* Sample: ____ units (assay individually); ___ units on retest
* Acceptance Criteria: ________
Content Uniformity
<25 mg, <25%
10 units, 20 units
85%-115% API
236
Measure of the time required for a tablet to break up into small particles
Disintegration
237
“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 no palpably firm core"
complete disintegration
238
Disintegration Test
Equipment ______________
Media temperature _____________
Cycles/minute ___________
Media type ___________
basket rack assembly
37 ± 2 deg c
29-32
water, simulated gastric fluid, simulated intestinal fluid
239
Uncoated/IR tablet
Capsule
medium __________
temperature __________
time _________________
distilled water
37 ± 2 deg c
30 mins
240
Sublingual tab
medium __________
temperature __________
time _________________
distilled water
37 ± 2 deg c
2-3 mins
241
buccal tab
medium __________
temperature __________
time _________________
distilled water
37 ± 2 deg c
4 hrs
242
enteric coated tablet
medium __________
temperature __________
time _________________
distilled water
simulated gastric fluid
simulated intestinal fluid
37±2 deg c
5 mins (x)
1 hour (x)
1 hour (check)
243
disntegration test acceptance criteria
1. how many samples is required?
2. what is the acceptance criteria?
6
should disintegrate all, if not --> s2
s2 : add 12 units so 18 in total
NMT 2 should not disintegrate (pass : 16 or above should disintegrate)
244
Test for measuring the amount of time required for a given % of drug substance in a tablet to go into solution
Tmeperature:
dissolution
37±0.5 deg c
245
Type 1 Dissolution Apparatus
Basket (100 rpm)
246
Type 2 Dissolution Apparatus
Paddle (50 rpm)
247
Type 3 Dissolution Apparatus
Reciprocating Cylinder
248
Type 4 Dissolution Apparatus
Flow-through cell
249
Type 5 Dissolution Apparatus
paddle over disc
250
Type 6 Dissolution Apparatus
Revolving Cylinder
251
Type 7 Dissolution Apparatus
Reciprocating holder
252
stage 1 for dissolution test
6 samples
no unit should be less than Q + 5%
253
stage 2 for dissolution testing
6 + 6 samples = 12
average (12) should nlt Q
no unit should be less than Q-15%
254
stage 3 dissolution test
6+6+12 samples = 24
average (24) should not be less than Q
no more than 2 units should be less than Q-15%
no unit should be less than Q-25%
255
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
256
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
257
Bloom strength in the range of -______________ is considered suitable for capsule.
150 - 250 mg
258
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
259
Plant, animal and mineral preparations
absence of salmonella spp.
260
Oral preparation
absence of pseudomonas aeruginosa, E. coli, salmonella spp.
261
Ophthalmic
sterile
262
Topical preparations
absence of pseudomonas aeruginosa, staph aureus
263
Urethral, Rectal, Vaginal
absence of molds and yeast
264
Total Aerobic Count
Medium ________
setting _____________
Tryptone Soya Broth
Soybean-Casein Digest Broth
Tryptone Soya Agar
Soybean-Casein Agar
Tryptic Soy Agar
30 to 35°C for 18 to 24 hours
265
Total Combined Yeast and Mold Count
Medium ________
setting _____________
Potato Dextrose Agar/Broth
Saboraud Dextrose Agar/Broth
20 to 25°C for 2 to 3 days
266
For semisolids with labeled content of nmt 150g or 150ml
Minimum Fill
267
Sample for Minimum Fill
10 containers (assay individually); 20 containers on retest
268
Net content = ______ – __________
initial weight -final weight
269
Initial wt.: ____________
* Final wt.: ____________
container w sample
empty container (heated at 100 deg c for 5 mins then cooled)
270
acceptance criteria for aerosols
<60g or 60ml: >90%
≥60g or 60ml (but nmt 150g or 150ml): >95%
271
acceptance criteria for non aerosols
net content > labeled content
272
Metal particle in Ophthalmic ointments
* Sample: ___________ (extrude contents in peri dish)
* Heat __________ then cool
* Invert petri dish → count metal particles using microscope (_______)
10 tubes
85 deg c for 2 hrs
≥ 50 mcm
273
Acceptance criteria Metal Particles Ophthalmic:
* Total # of metal particles in all 10 tubes is _______
* Nmt 1 tube contains ___ metal particles
<50
>8
274
Single use: must pass ______________
Multiple use: must pass ________________
sterility test
antimicrobial effectiveness test
275
Deliverable volume
* Applicable for liquid products nmt _______
* Sample size: ______ containers; ___ containers on retest
* Procedure: (Angle: ___°; prevent air-bubble formation)
* Single unit: drain in ______________
* Multiple unit: drain in ______________
250 ml
10; 20
30 deg
5 seconds
≤ 30 mins
276
_____________________
* Free for all particle velocity on Andreasen pipet based on Stokes law
* Particle size:
o Solution
o Colloidal
o Suspension
Sedimentation Rate (F)
0.1-1 nm
1-100 nm
> 100 nm
277
Ratio of the height of sediment settled after standard condition and with the initial height of the suspension.
Sedimentation Volume
278
REDISPERSIBILITY
* Ideal: ____% with minimum agitation
100 %
279
RHEOLOGICAL PROPERTIES: VISCOSITY
* Measure of __________
* Should not be too fluid nor too viscus
resistance to flow
280
ZETA POTENTIAL
* Repulsive forces between particles
* __ zeta potential = __ Settling = __ stability
increase = decrease settling = increase stability
281
. TEMPERATURE AND GRAVITATIONAL STRESS
* T: ___°C
* Centrifugation: ______________
40 deg c
crystal growth
282
