問題一覧
1
PAB
Pharmaceutical Affairs Bureau (Japan)
2
PAHO
Pan American Health Organization
3
PCR
Polymerase Chain Reaction
4
MOU
Memorandum of Understanding
5
LDE
Long Lead Delivery Equipment
6
PDA
Parenteral Drug Association
7
OSBL
Outside Battery Limit
8
PFD
Process Flow Diagram
9
NEMA
National Electrical Manufacturers Association
10
MAL
Material Air Lock
11
M/C
Mechanical Completion
12
MB
Material Balance
13
MPs
Medium Plant Steam
14
MAA
Marketing Authorization Application
15
OOF
Out of Freeze
16
NEPA
National Environmental Policy Act
17
MVM
Minute Virus of Mice
18
PCS
Process Control System
19
KFDA
Korean Food and Drug Administration
20
PAT
Process Analytical Technology
21
LIMS
Laboratory Information Management System
22
PAQ
Polyalphaolefin
23
NOAEL
No Observed Adversed Effect Level
24
MS
Mass Spectrometer
25
OOS
Out of Specification
26
MCB
Master Cell Bank
27
MSDS
Material Safe Data Sheet
28
OV(OQ)
Operational Verification (Operational Qualification)
29
OEM
Original Equipment Manufacturer
30
LOP
Local Operating Panel
31
PI System
Plant Information System
32
NDA
New Drug Application (FDA)
33
MALDI-TOF
Metrix Assisted Laser Desorption / Ionization Time of Fight
34
MKT
Mean Kinetic Temperature
35
MBR
Manufacturing Batch Record
36
MHRA
Medicines and Healthcare Products Regulatory Agency
37
MCS
Manufacturing Control System
38
NWP Test
Nomalized Water Permeability Test
39
MHLW
Ministry of Health, Labor and Welfare (Japan)
40
LC-MS
(High Performance) Liquid Chromatography - Mass Spectrometry
41
PAL
Personnel Air Lock
42
PDR
Physicians' Desk Reference
43
MAC
Master Training Coordinator
44
NIH
National Institutes of Health (DHHS)
45
PAHO
Pan American Health Organization
46
MA
Marketing Authorization
47
MTX
Methotrexate
48
P&ID
Pipping and Instrument Diagram
49
mAB
Monoclonal Antibody
50
PCD
Picogram / Cell / Day
51
OPC
OLE Process Control (OPC) Object Linking and Embedding (OLE)
52
OTC
Over - The - Counter
53
OOT
Out of Tolerance