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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5737_Библиотеки_им_академика_М_И_Перельмана
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249QA/QC Release
9. During the review, what will be the next step if all results comply with
the specication?
Answer: The batch will be released and sent to distribution.
10. What are the packaging components?
Answer: Packaging pharmaceutical products are bottles, blister packs,
labels, inserts, and outer cartons.
11. What are the packaging components?
Answer: Packaging pharmaceutical products are bottles, blister packs,
labels, inserts, and outer cartons.
12. What tests are performed on packaging components?
Answer: These tests include dimensional checks, visual inspections, func-
tional assessments, and verication of printed information such as bar-
codes, batch numbers, and expiry dates. The components may also undergo
specic tests, such as container leak tests or ink adhesion tests for labels.
13. What common tests are being performed during in‑process testing?
Answer: Moisture/Loss on drying test at the granulation stage, pH, Weight
variation, Hardness, Disintegration, Content uniformity and Assay of active
ingredients.
14. What are the objectives of in‑process testing?
Answer: (1) To optimize the technical procedure used in the manufacturing
process. (2) To monitor, control, and improve the applied operations effec-
tively at every stage of the nished pharmaceutical products. (3) Inspection
of raw material, equipment, environment, process, and testing with respect
to specication, packing, etc. (4) Quality and process control.
15. What should be an analyst’s action if he nds an OOS result?
Answer: Inform management immediately.
16. If an LIR is in the process, what would be the status of the effecting
batch?
Answer: It will be on hold until the LIR is closed.
17. During an investigation, when is the re‑sampling required?
Answer: Re-sampling is performed only when the original sample is
exhausted or degraded. Re-sampling can also be performed when the initial
investigation identies a potential sampling error or the sample obtained is
not homogenous or representative of the lot/batch. A solid scientic ratio-
nale is required.
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251
Index
aberrant result 243–245
accelerated studies 183, 185, 188
accelerated testing 182–184
acceptable quality limit 89
acceptance criteria 36, 43, 70, 82–84, 87, 96, 107,
108, 110, 115, 123, 135, 136, 157, 158,
186 , 219
, ,
active pharmaceutical ingredient 32, 220,
23 7, 248
AL COA 63 – 67
ambient condition 187
ambient temperature 227, 229
American Chemical Society 28
anhydrous basis 28
application screen ow 178
approved procedure 5, 247
AQL 82, 89, 107
aseptic manufacturing 199, 204
atomic absor ption 29, 123
attributable 63, 64, 66, 67, 202
autoclaving 203
autoinjector 19
backpressure 127
be nc h mar k ing 216
bill of material, (BOM) 173, 193, 195
bioavailability 231, 232
biologics 25, 230–235
biosimilar 65, 230, 231, 234, 235
blend uniformity 77, 87, 88, 91, 94, 99
blending 77, 78, 85, 87, 91, 94, 99, 100, 102, 198,
201, 207
blistering 81, 85, 95, 106, 112
bracketing 183
buffer solution 21, 29, 30, 54, 55, 57
CAPA 8, 221, 246, 248
capacity factor 130
certicate of analysis 9, 20, 57, 220, 247
change control system 11, 221
change control tracking 12
chromatography 123, 126–128, 130, 234
chromophore 127
clean in place (CIP) 118
clean out of place, (COP) 118, 125
cleaning agent 121–123, 125
cleaning agents grouping 121, 122, 123, 125
cleaning methods grouping 121
cleaning validation 9, 117–125
cold chain supply 226 –229
cold chain support 227, 229
colorimetric solution 29
column 17, 126–129, 132, 133
column heater 17, 128, 133
commercial manufacturing 3, 12, 189
commercial product 36, 71, 93, 115, 189,
191, 220
commercial production 71, 93, 115, 189, 191
composite sample 32, 33
compression 77, 80, 85, 89, 95, 99, 103, 106, 112,
183, 198, 207, 241
concurrent validation 70–72
constant weight 49
container closure system 184
contemporaneously 63
content uniformity 32, 34, 47, 88, 103, 114, 203,
242, 249
context diagram 178
control air 170
corrective and preventive action 221, 246
correlation coefcient 131
critical alarm 165, 166
critical quality attribute 35, 69, 70, 72, 115
cross-contamination 194, 215, 217
data ow diagram 178, 180
data integrity 6, 63–67, 239
data logger 227–229
data security 63, 67
degra dat e 182 , 183, 185, 187
degradation product 35, 36, 131, 132, 183–187
design qualication (DQ) 134, 135, 139
design specication 69, 72, 156, 173
detection limit 126, 132
detector noise 127
diluent 129
diluting solvent 32, 37, 38, 129
direct surface monitoring 123, 125
disintegration 39, 51–54, 61, 77, 80, 99, 103,
242, 249
dispensing 74, 193–197, 214
dispersible tablet 54, 61
dissolution 19, 20, 23, 38–46, 48, 103, 104, 106,
108, 109, 113, 114, 221, 225, 241, 242
DNA 230
dosage form 32, 39, 40, 41, 47, 76, 89, 98, 106,
121, 124, 126, 198, 199, 202, 206, 207,
210, 226, 230, 231, 235, 242, 246
dried basis 28
dried granule 79, 102
drug substance35, 36, 184, 187
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252 Index
electrode 20–23, 55–57, 61
electronic record 6, 66, 219
elemental impurities 35
emergency stop165
encapsulator 198, 206
equipment grouping 121
equipment train 119
excipient 6, 32, 36, 76, 77, 88, 98, 99, 120, 131,
198, 220, 236, 237, 248
expiry date 21, 55, 85, 96, 112, 182, 188, 193, 211,
240, 249
extended investigation 244, 245
external contamination 244
FDA 11, 13, 14, 63, 68, 71, 72, 93, 139, 216, 219,
232–234
lm-coated tablet 41, 44
ame photometry 29
ow rate 17, 18, 33, 37, 126–128, 132, 146–148
uorescence detector 127
force degradation 130, 132, 133, 187
formal stability studies 183, 184, 188
friabilator 16, 23, 59, 60
friability 16, 60, 62, 77, 99, 113
functional specication 165, 173, 175–179, 181
GDP 1, 3, 5, 7, 9, 11, 13, 64, 222
glass electrode 20, 55
good documentation practice1
good laboratory practice1, 5, 27, 234, 235, 238
good manufacturing practice1, 4, 12, 68, 69, 72,
193, 218, 219, 231, 235, 238, 246, 247
granulating 77, 78, 95, 99, 100, 101
granulation 78, 94, 101, 207, 241, 249
hard capsule 55
hardness 58, 59, 62, 77, 80, 99, 103, 241, 249
health regulatory bodies 117, 226
HEPA lter 195
historical record 243
homogeneity 87, 90, 96, 201
homogenization 245
HPLC 17–19, 23, 32, 33, 37, 44–46, 123,
126–130, 132, 219, 225
hydrogen ion 20, 29, 30, 50, 55
hydrophobicity 121
ICH guidelines 68
immunoassays 234
impurity standard 25
indicator 29, 30, 166
injection volume 33, 37, 126, 128
initial lab assessment 243
inorganic impurities 35
inorganic salt 35
in-process 49, 55, 81, 85, 90, 103, 201, 203, 220,
225, 241, 245
in-process control 3, 74, 97, 225, 241
installation qualication (IQ) 134, 136–141
instrument malfunction 244
interface diagram 178, 180
intermediate product 3, 224
intermediate storage condition 184, 185
international standard (IS) 25, 216
in-vitro assay 234
ion-pair reagent 126, 128
Ishikawa diagram 216, 217
ISO 168, 216
Karl Fischer (KF) 50
known impurity 37
lab investigation report (LIR) 243
laminar ow hood 195
leak test 81, 106. 240, 249
lifecycle 3, 12, 27, 64–66, 176, 215, 222, 225
LIMS 7, 239
linear regression 19, 131, 186
linearity 18, 19, 126, 130, 131, 133
liquid-liquid extraction 129
LOD 30, 49, 50, 61, 77, 79, 95, 99, 101, 102
logistics 226–229
long term testing 183
loss on drying 28, 30, 49, 50, 79, 241, 249
lubrication 60, 79, 95, 102, 172
lyophilized 26
manufacturing equipment 1, 12, 74, 117, 152
manufacturing facilities 2, 120, 233
manufacturing process 1, 2, 4, 5, 8, 9, 12, 35,
36, 68–74, 93, 94, 95, 99, 115, 146,
193, 198, 200, 201–204, 206, 207,
214, 220, 221, 230–232, 235, 240,
241, 249
mass balance24
matrixing 120, 183
mesh size 40, 51
method development 37, 126, 129, 131, 133
method validation 9, 15, 16, 22, 70, 126, 127,
129–131, 133, 246
microbial testing 221, 225
milling 77, 99, 198, 199, 207
mobile phase 17, 19, 32, 37, 126–132
molarity 29, 30, 128
national formulary (NF) 24
negative charge 128
noise level constraint 171
non-polar 127, 128
nonsterile 220
Occupational Safety and Health Administration
(OSH A) 2 6
ointment 32, 198, 199, 202
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253Index
OOS 18, 60, 82, 91, 107, 196, 205, 224, 225, 243,
244, 246, 249
operational qualication (OQ) 135–139
organic impurities 35, 36
out-of-specication (OOS) results 70, 224,
239, 243
out-of-trend (OOT) results 243
packaging 3 –5, 8, 15, 26–28, 58, 70, 74, 75, 81,
88, 91, 95, 97, 98, 106, 115, 155, 184,
187, 193, 195–197
packaging components 218, 220, 224, 236, 238,
240, 248, 249
paddle 19, 23, 39, 41, 43, 45, 48
parameter control tolerance164
performance qualication (PQ) 69, 72, 135, 136,
138, 139
personal protective equipment (PPE) 194, 237
pH 20–23, 29, 30, 54, 55, 56, 57, 61, 62, 98, 101,
106, 117, 123, 126, 128, 133, 138, 163,
170, 178, 203, 220, 225, 241, 249
pH meter 20–23, 29, 30, 55, 61, 62, 138
pharmaceutical quality 2–4, 232
pharmaceutical quality system 3, 4
Pharmaceutical Regulatory Agency 63
phosphate buffers 54, 129
physical tests 49
pilot batches 69, 189, 191
placebo 37, 38, 130, 131
positive charge 128
prima ry packaging 197, 199, 207, 210, 211, 213
prima ry packaging materials (PPM) 197
prima ry standard 24
process ow diagram 177, 178, 200, 202
process impurities 131
process validation 9, 15, 16, 22, 68–71, 73–75, 87,
91, 93, 95, 97, 115, 135, 190
product grouping 121, 124
project plan 172, 173, 189
prospective validation 70–72, 96, 115
protocols 9, 69, 71, 93, 115, 180, 204, 222,
233, 238
quality assurance4, 12, 69, 70, 86, 96, 136, 138,
141, 153, 156, 174, 193, 194–209, 212.
214, 215, 216, 217, 218, 224, 228, 231,
232, 234, 237–239, 243, 246
quality control 1, 4–6, 12, 32, 49, 50, 68, 70, 75,
193, 194, 209, 213, 214, 215, 216, 218,
219, 220, 221, 223, 224, 225, 231–241,
243, 246, 247
quality management 2, 66, 215, 218
quantitation limit 126, 130, 132, 133
quantitative determination 25, 29, 30
raw material 2, 5, 8, 13, 49, 51, 53, 55, 57, 59, 61,
73, 74, 76, 77, 97–99, 153, 155, 190,
195, 196, 202, 218, 220, 224, 231, 232,
236, 238, 240, 248
raw material evaluation report 88, 92
reagent grade 21, 28, 57
reagents and catalyst 35
reagents and ligand 35
re-analyze 245
recalibrate 16
re-dilution 244, 245
re-extraction 245
reference standard 24, 25, 27, 29, 31, 190, 221
refractive index 127
refrigeration control 227, 229
regression coefcient 19, 131
re-injection 244, 245
related substances 32, 35, 83, 110, 114, 242
relative humidity 184, 194, 227, 229
relative standard deviation 59, 114, 130
re-sampling 245, 249
residual solvent 35
resolution 130, 153, 159, 245
re-testing 245
retrospective validation 70, 71
revalidation 70, 71, 88, 92, 95, 115
reverse-phase column 127
ribbon blending 87, 91
rinse sampling 123, 125
risk management 2–4, 70, 190, 222, 223, 225
risk management principle 3, 4
robustness 126, 130, 132, 133, 192
role of quality control 5, 218, 219, 221, 223, 225
root cause analysis 3, 246
RPM 19, 20, 39, 41, 45, 60, 77, 99, 202
run time 33, 37, 45, 89, 172
sample preparation 33, 45, 126, 129, 238, 244
sample stock 33
secondary packaging 195, 210, 211
secondary standard 24, 30
self-inspection 4
separation techniques 126
setpoint range 164
shelf life 3, 4, 11, 182, 183, 226
sieving 77, 78, 99
SIM method 187
si n ker 41
sitemap178
soft capsule 55
specicity 123, 126, 130, 133
spectrophotometer 20, 127
stability chamber 185
stability commitment 185
stability indicating method 187
stability storage conditions 184
stability studies 36, 182–188, 244
standard operating procedure 1, 7, 9, 27, 122, 215,
216, 219, 227, 229, 239
standard stock 33, 37, 45
standard working 33, 37, 38, 45
stationary phase 126, 127
sterile testing 220
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254 Index
sterility 11, 14, 199, 207, 222, 234
stress conditions 184
stress testing 183, 187
strip pack 210, 211, 213
sufcient premises 2
sulfonate buffer 129
supply chain 3, 215, 222, 226, 228
swabs and wipes 122–124
syringe lters 129
system suitability 9, 13, 26, 126, 129, 130, 219,
223, 24 4
tailing factor 130
technology transfer 3, 9, 12, 189–192
temperature mapping 222, 227–229
terminal sterilization 199, 207
tertiary packaging 210, 211
test method 190, 219, 223, 225, 234, 238
test solution 29
testing frequency 184, 187
theoretical plate 130
thin-layer chromatography (TLC) 123
total organic carbon (TOC) 123
toxicology 36
uncoated tablet 44, 53, 54
United States Pharmacopeia (USP) 24
unk nown impurity 37
UPLC 126, 130
US Food and Drug Administration 68, 93
USP standard 24
UV detector 127
validated method 32, 187, 246
validation protocol 69, 71, 73, 87, 93, 115, 152,
156, 190, 192
vessel 19, 20, 43, 45, 123
vitro 36, 234
volatile 27
volumetric ask 18, 33, 34, 37, 38, 45, 47, 48
volumetric solution 29, 30
wavelength 45, 126, 127, 129, 132
weighing bottle 49, 61
weight variation 77, 80, 99, 104–106, 202, 241, 249
wet granulation 78, 101
WHO 25, 216
y-i n ter cep t 131
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