*

1. : " "
(http://www.ksbb.or.kr/home/kor/word/list.asp)
2. FDA: Drugs@FDA Glossary of Terms ( FDA, http://www.fda.gov/cder/drugsatfda/glossary.htm)
3. SureGMP GMP : www.suregmp.com
4. GMP(, , sureGMP, 2005)
5. SureGMP Validaiton : www.suregmp.com
6. EGA Glossary: European General Medicines Association (EGA, , http://www.egagenerics.com/) glossary
7. : ( , 1999) (www.kfda.go.kr)
8. IVT: The Validation Dictionay, Institute of Validation Technology (IVT, http://www.ivtconferences.com/)
9. ISPE: International Society for Pharmaceutical Engineering, http://www.ispe.org/
10. ICH: The International Conference on Harmonisation, http://www.ich.org/
11. (http://www.labcompliance.com; http://www.emea.eu.int )

No.

, ,
1 acceptance criteria EU GMP Glossary
. .
. , 99.0%
, 1 98.5%, 2 97.0% , 1
2 accuracy
2 . (precison)
(linearity) .
(consistency) .
3 action limits sureGMP GMP
.
, , , ,
4 active ingredient . ,
.
.
5 active moiety FDA
, , .
6 actual yield , .
adequate directions
7 . FDA
for use
.
ADI (acceptable daily sureGMP validation
8 (maximum no effect level, MNEL)
intake)
.
No.

ADME (absorption,
/// . , , , ,
distribution, ///
9
metabolism, and
.
excretion)
ADR (adverse drug .
10 sureGMP GMP
reaction) AE/ADE (adverse drug event/adverse drug effect) .
adverse drug .
11
experience .
FDA . FDA " "
AERS (adverse event
12 FDA
reporting system)
.
affinity
13
chromatography .
, ,
. , / , ,
14 air handling systems (, , HEPA) . 1 sureGMP GMP
, (, )
2 .
DOP(dioctyl phthalate) .
15 air-generated DOP DOP sureGMP GMP
. DOP PAO (Poly Alpha Olefin)

16 air-lock sureGMP GMP
. .
.
17 amorphous form
.
ANADA (abbreviated
FDA . sureGMP validation
18 new animal drug
.
application)
, . , sureGMP validation
19 analytical procedure
, , , , .
ANDA (abbreviated FDA . sureGMP validation
20
new drug application) .

ANOVA (analysis of .
21 sureGMP GMP
variances) . .
.
No.

.
22 ANSI sureGMP GMP
.
.
23 antibody
(Ig) .
. 1000 , ,
24 antigen
. .
AOAC (association of
.
25 official analytical AOAC sureGMP GMP
.
chemists)
API (active , , , . .
26 pharmaceutical , , , , . EU GMP Glossary
ingredient) (drug substance) .
.
27 API starting material API EU GMP Glossary
,
FDA , ,
28 applicant sureGMP GMP
.
.
29 application () sureGMP GMP
. .
FDA . ,
30 approvable letter FDA QnA
.
, , . OC(operating
AQL (acceptance sureGMP validation
31 characteristic curve) 4 ((AQL), (LTPD),
quality level)
(), ()) .
. , , ,
32 asbestos , ,
.
33 aseptic sampling
ASME (American
. ASME ,
34 society of mechanical sureGMP GMP
.
engineers)
ASQ (American . ,
35 FDA QnA
Society for Quality) .
ASQC (American
()
36 Society for Quality ASQ (American Society for Quality) . FDA QnA

Control)
No.

, . sureGMP validation
37 at-rest facility
as-built operational
. 121 , 2
38 autoclaving
.

39 background carbon , , , sureGMP GMP

(cyanobacteria) .
40 bacteria . .
.
,
41 batch (or lot) . , , sureGMP GMP
. (lot) .
42 batch culture .
. .
43 batch number FDA
. (lot number) .
44 bioaccumulation . sureGMP GMP
.
45 bioassay
, .
(active ingredient) (active moiety)
46 bioavailability sureGMP GMP
.
, API , , API . sureGMP GMP,
47 bioburden
, EU GMP Glossary
48 bioconcentration . sureGMP GMP
49 bioefficacy .
, (mole) ,
50 bioequivalence sureGMP GMP
.

51 biogenerator . . , , sureGMP GMP
.
biological (biologic) . , sureGMP validation
52
product , , .
. (potency)
53 biological activity FDA
.
, , ,
54 biological agents
.
No.

, , sureGMP validation
55 biomass
. , .
. , , ,
56 biopharmaceutical
, .

57 CA (corrective action) sureGMP GMP
.
(reference standard) sureGMP GMP,
58 calibration
(traceable standard) EU GMP Glossary
, , ,
CBER (Center for
FDA . , , ,
59 Biologics Evaluation sureGMP GMP
. , ,
and Research)
, , AIDS .
CDER (Center for FDA .

60 Drug Evaluation and , , , sureGMP GMP

Research) .

CDRH (Center for
FDA . ,
61 Devices and sureGMP GMP
,
Radiological Health)
(Performance Standard) GMP , ,

. (master cell bank) (working cell bank)
62 cell bank system sureGMP GMP
. (passage level) (number of
population doublings) .
63 cell culture . sureGMP GMP
64 centrifugation .
CFR (Code of Federal (Federal Register) .
65 sureGMP GMP
Regulation) .
CFSAN (Center for
FDA .
66 Food Safety and sureGMP GMP
.
Applied Nutrition)
CFU (colony forming ,
67
unit) .
cGCP (current good , , ,
68 sureGMP GMP
clinical practice) .
No.

CGMP (current good

, , , FDA ()
69 manufacturing

practice)
.
70 chirality . .
(chiral).
, , . sureGMP validation
71 clean area
Supplementary Guidelines for the Manufacture of Sterile Medicinal Products .
72 clean bench . .
. (GMP),
73 clean room
(GLP) .
,
74 clinical Investigation .
(clinical trial) .

75 clinical trial . 3(1/2/3) .
.
76 clinically superior (orphan drug) . sureGMP GMP
CMC (chemistry,
, , . IND (investigational new drug)
77 manufacturing and sureGMP GMP
.
controls)
78 color additive 21 CFR 70.3: FDCA 201(t) , . FDA
79 combination product . sureGMP GMP
. ,
80 complement .
, .
. (molasses), (malt extract),
81 complex medium
(yeast extract), (peptone), (meat extract), (corn steep liquor)
82 component , . . sureGMP GMP
, , sureGMP validation
83 compressed gas
.
, , ,
84 computer system sureGMP GMP
.
concurrent / ongoing , sureGMP validation
85
validation .
No.

. sureGMP validation
86 confinement
,
.
sureGMP validation
87 contained area .

. 1
(primary containment)
sureGMP validation
88 containment (safety cabinet) . 2 (secondary

containment) ,
(air-lock), . Confinement .
, , sureGMP validation
89 contaminants
.
, , , , , , , (API) sureGMP validation
90 contamination
, , .
sureGMP validation
91 contract manufacturer .
, EU GMP Glossary
sureGMP validation
92 contraindications
.

93 controlled area . (organism) . FDA
.
94 cross contamination . sureGMP GMP
95 crude drug , , , . GMP
96 crude plant . sureGMP GMP
sureGMP validation
97 cryogenic gas 1000 , 150 .

sureGMP validation
98 cryogenic vessel . Cryogenic container .

, , .
99 cryopreservation
.
.
100 crystalline form
.
. ,
101 crystallization
(polishing) . , (nonsolvent)
102 culture broth , , .
No.

CVM (Center for , ,

103 sureGMP GMP
Veterinary Medicine) FDA .
, , pH, ,
104 degradation product . , sureGMP GMP
. Decomposition product .
105 detail specification .
. sureGMP validation
106 detection limit
. . LOD(Limit of Detection) .

107 deviation . EU GMP Glossary

DMF (drug master , , , , US FDA

file) FDA .
108 . DMF IND, NDA, ANDA, DMF,

. DMF IND, NDA, ANDA .
DOP (dioctyl DOP HEPA filter (integrity) .
109 phthalate) test DOP HEPA filter (3.0) filter . DOP
PAO (polyalphaolefin) .
DQ (design , ISPE
110
qualification)
, , , , .
111 drug sureGMP GMP
.
, , ,
112 drug evaluation
.
, ,
113 drug interference
.
(dosage form) . , ,
114 drug product sureGMP GMP
(placebo) .
115 drug substance (API: active pharmaceutical ingredient) . EU GMP Glossary
.
116 efficacy
potency() .
EIR (establishment , FDA
117 sureGMP GMP
inspection report) .
No.

emergency use IND 21CFR 312.23 312.34 IND FDA US FDA

118 .
.
(lipopolysaccharide).
119 endotoxin
(pyrogen)
120 exotoxin . (endotoxin)
expiration dating () . Expiry date
121 sureGMP GMP
period .
FDA . FDA
122 FDA form 483 FDA 483 sureGMP GMP
. CGMP .
123 fermentation .
. , , , , , pH
124 fermenter / fermentor
. .
125 filtration .
126 finished product . sureGMP GMP
. ,
. . ,
127 formulation
(solution), (tablet), (capsule) (powder) (aerosol)
.
functional . , ,
128
specification .
GCP (good clinical ICH , . ICH
practice) , . GCP
129
, ,
.
generic medicine , .
130
.
,
GLP (good laboratory
131 , , , ,
practice)
. .
. , ,
GMP (good

132 manufacturing
, ,
practices)
. .
No.

0.3 m 99.97 % .
133 HEPA filter
, .
.
high performance ,
134
liquid chromatography . 1015 m 1003001 psi.
(high pressure liquid chromatography) .
. ,
135 homogenizer
, .
HVAC (heating .
136 ventilation and air (AHU; air handling unit), heating coil/cooling coil, /, ,
conditioning) system (primary filter, medium filter, HEPA filter) .
IB (investigator's . 21 CFR 312.23 , US FDA
brochure) . 1
137
,
.
ICH (International , , ,
138 Conference on . ICH
Harmonisation) .
139 impurity API EU GMP Glossary
140 inactive ingredient (active ingredient) (21 CFR US FDA
IND (Investigational
141
New Drug) Application .
in-house reference 1
142
material . 1 .
1) , , (inoculum) . 2)
143 inoculation
.
144 inoculum , .
145 in-process material .
146 intermediate API . API . EU GMP Glossary
IQ (installation , ISPE
147 qualification) . GMP , ,
.
LIMS (laboratory

148 information IT .

management system)
No.

, . (seed culture)
149 main culture
.
manufacturing , , ,,,,,, API
150 EU GMP Glossary
process

151 master cell bank
.
. (, , ), (process aids),
152 material EU GMP Glossary
, API, , .
media fill test BDS (bulk drug substance) (fill & finish)
153
.
154 medicament .
, , ,
155 medium
.
.
156 minimal medium
. , .
MPR (master .
157
production record) . MBR (master batch record) .
NCE (new chemical , (salt) (complex, chelate, clathrate),
158
entity) (salt ester) . NME (new molecular entity) , wikipedia
NDA (new drug
159 . .
application)
160 new indication EGA Glossary

161 non-conformity IVT
.
non-fiber-releasing .
162 sureGMP GMP
filter fiber-releasing filter .
OOS (out of , , .
163
specification)

OQ (operational
164 . (specification) IVT
qualification)
.
originator medicinal . EU
165 EGA Glossary
product 15 .
166 orphan drug .
OTC (over the
167 . GMP
counter) Drug ()
No.

. , , ,
168 pathogenicity . (virulence)
.
, GMP .
.
169 PDA PDA Parenteral Drug Association (PDA) An International Association IVT, sureGMP
for Pharmaceutical Science and Technology . "PDA"
.
, , ,
PQ (performance
170 . (specification) IVT,
qualification)
.
.
171 precision

()
172 preclinical phase
. , .
primary reference 1 . . (1) ICH Q7A
173 standard , (2) , (3)
, (4) .
API . ,
174 process aid EU GMP Glossary
. , .
,
175 process validation , IVT
.
, , , .
176 product contact area IVT
.
.
. , ,
177 protocol IVT
. (Validation Final Report)
.
, ,
178 qualification EU GMP Glossary, IVT
. .
179 retention time .

180 RO (reverse osmosis) . () .
.

181 safety cabinet
.
No.

.
182 solvent extraction
, .

,
. () , , .
SOP (standard
183 . , , ,
operating procedure)
.
.
.
184 standard
.
185 sterilization , .
(accelerated testing)
186 stress testing
. .
treatment IND FDA US FDA
187 (investigational new .
drug)
, ,
188 validation . (state of control) IVT, EU GMP Glossary
.
. -70
189 working cell bank
.

190 working standard
. .