Glossary, Acronyms and General words for Pharmaceutical Industry
Version: 00, Date: March 7, 2019
Note:
Glossary, Acronyms and General words are collected and collated from WHO, EU GMP, ISO14644, ISPE, FDA, ICH, PIC/S. And will be updated periodically by Foshan RuiTong Consulting Co.,Ltd.
Table of Contents
1. Glossary.PAGEREF _Toc2853244 \h3
2. Abbreviations & acronyms.PAGEREF _Toc2853245 \h34
3. General words for water system..PAGEREF _Toc2853246 \h39
4. General words for QC Laboratory.PAGEREF _Toc2853247 \h41
5. General words for HVAC system PAGEREF _Toc2853248 \h44
1. Glossary
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2. Abbreviations & acronyms
ACPH: Air changes per hour
ADR: Adverse drug reaction
AHU: Air-handling unit
API: Active pharmaceutical ingredient
APIMF: Active pharmaceutical ingredient master file
ATCC: American Type culture collection
ARV: Antiretroviral
BAS: Building automation system
BI: Biological indicator
BCS: Biopharmaceutics Classification System
BFS: Blow-fill-seal system
BMGF: Bill & Melinda Gates Foundation
BMS: Building management system
BSL: Biosafety level
CAPA: Corrective and preventive action
CDER: Center for drug evaluation and research
CFU: Colony forming unit
CIP: Clean in place
CMC: Chemistry, manufacturing and control
COA: Certificate of Analysis
COD: Chemical oxygen demand
CP: Compliance program
CPP: Critical process parameter
CPU: Central processing unit
CQA: Critical quality attribute
CRO: Contract research organization
CROMF: Contract research organization master file
CRS: Chemical reference substance
CTD: Common technical document
C&Q：Commissioning & qualification
DAD: Diode-Array Detector
DCS: Distributed control system
DDS: Detailed design specification
DEC: Diethylcarbamazine
DI: Deionized water
DMF: Drug master file
DNDi: Drugs for Neglected Diseases initiative
DQ: Design qualification
DS: Design specification
E.Coli: Escherichia Coli
eCTD: Electronic common technical document
EDI: Electro-deionization
EDQM: European Directorate for the Quality of Medicines
EIR: Establishment Inspection Reports
EMS: Environmental Monitoring System
EOI: Invitation to Manufacturers to Submit an Expression of Interest for Product Evaluation
EP:European pharmacopoeia
EPDM: Ethylene-propylene-diene monomer
ERP: Enterprise resource planning
EU: European Union
FAT: Factory acceptance test
FDC: Fixed-dose combination
FDA: Food and drug administration
FDS: Functional design specification
FIFO: First in First out
FMEA: Failure mode and effects analysis
FPP: Finished pharmaceutical product
FS: Functional specification
GAMP: Good automated manufacturing practice
GCP: Good clinical practices
GDP: Good distribution practice
GEP: Good engineering practice
Global Fund: Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria
GLP: Good laboratory practices
GMO: Genetically modified organism
GMP: Good manufacturing practice
GPS: Global positioning system
GXP: Acronym for the group of good practice guides governing the preclinical, clinical, manufacturing, testing, storage, distribution and post-market activities for regulated pharmaceuticals, biologicals and medical devices, such as good laboratory practices, good clinical practices, good manufacturing practices, good pharmacovigilance practices and good distribution practices.
HACCP: Hazard analysis and critical control points
HBV: Hepatitis B virus
HCV: Hepatitis C virus
HDD: Hardware disk drive
HDPE: High density polyethylene
HIV/AIDS: Human immunodeficiency virus/acquired immune deficiency syndrome
HEPA: High-efficiency particulate air
HMI: Human-Machine interface
HPLC: High pressure liquid chromatography
HSE: Health, safety and environment
HVAC: Heating, ventilation and air-conditioning
I/O: Input/output
I/O Port: Input/outpu connector
IBC: Intermediate bulk container
ICH: International conference on harmonization
ICRS: International chemical reference substance
ID: Identification/Identity
IP: International Pharmacopoeia
IQ: Installation qualification
IND: Investigational new drug
INN: International nonproprietary names
In vivo: Testing conducted in living animal and human systems
In vitro: Non-clinical testing conducted in an artificial environment such as a test tube or culture medium.
IR: Infrared
ISO: International standards organization
ISPE: International society for pharmaceutical engineering
IT: Information technology
IUPAC: International Union of Pure and Applied Chemistry
JP: Japanese Pharmacopoeia
KPI: Key performance indicator
LAF: Laminar air flow
LC/MS: Liquid chromatography/mass spectrometer
LC50: Lethal concentration-50%
LD50: Lethal dose-50%
LDPE: Low density polyethylene
LEL: Lower explosive limit
LFL: Lower flammability level
LIF: Laboratory information file
LIMS: Laboratory information management system
LVP: Large volume parenteral (more than 100ml)
LYO: Lyophilizer (freeze dryer)
MAH: Marketing authorization holder
MCB: Master cell bank
MSDS: Material safety data sheet
MWCB: Manufacturers working cell bank
NDA: New drug application
NF: National formulary
NMRA: National medicines regulatory agency
OD: Outside diameter
OEL: Occupational exposure limits
OOS: Out of specification
OSD: Oral solid dosage
OTC: Over the counter
OQ: Operational qualification
RABS: Restricted access barrier system
RO: Reverse osmosis
PAD: Pulsed amperometric detection (in HPLC)
PAT: Process analytical technology
PDE: Permitted daily exposure
PE: Polyethlene
PFD: Process flow diagram
PIC/S: The pharmaceutical inspection co-operation scheme
PK: Pharmacokinetics
PM: Preventive maintenance
PQ: Performance qualification
PQTm: Prequalification Team (of the World Health Organization)
PIL: Patient information leaflet
PLC: Programmable logic controller
PTFE: Polytetrafluoroethylene (Teflon)
PVC: Polyvinyl chloride
PVDC: Polyvinylidene chloride
PVDF: Polyvinylidene fluoride
PW: Purified water
P&ID: Process/Piping and instrumentation diagram or drawing
QbD: Quality by design
QC: Quality control
QCL: Quality control laboratory
R&D: Research and development
RH: Relative humidity
RO: Reverse osmosis
SAT: Site acceptance test
SCADA: System control and data acquisition system
SDS: Software design specification
SEM: Scanning electron microscopy
SIP: Steam sterilize in place
SME: Subject matter expert
SMF: Site master file
SOP: Standard operating practice
SRA: Stringent regulatory authority
SVT: Small volume parenteral (less than 100ml that are terminally sterilized)
SVS: Small volume parenteral are sterilized by filtration and aseptically processed.
SVL: Small volume parenteral are sterilized by filtration, aseptically filled and lyophilized.
SLQ: Sterile liquid (other than suspensions and emulsions)
SON: Sterile ointment
SPW: Sterile powder
CSN: Non sterile API by chemical synthesis
CSS: Sterile bulk drugs that are made by chemical synthesis
CFS: Sterile crude drugs (API) made by fermentation
TB: Tuberculosis
TGA: Therapeutic Goods Administration (Australia)
TLC: Thin-Layer Chromatography
TOC: Total organic carbon
TSE: Transmissible spongiform encephalopathy
UDAF: Unidirectional airflow
UF: Ultra filtration
UPS: Uninterruptible power supply
UPW: Ultrapure water
USP: United states pharmacopoeia
USAN: United states adopted names
URS: User requirements specification
US: United states
USB: Universal serial bus
UV: Ultraviolet Light
VMP: Validation master plan
VOC: Volatile organic compound
WCB: Working cell bank
WFI: Water for injection
WHO: World Health Organization
WHOPAR: WHO Public Assessment Report
WHOPIR: WHO Public Inspection Report
WO: Work Order
WPU: Water for pharmaceutical use
XRPD: X-Ray Powder Diffraction
3. General words for water system
- Drinking water
- Feed water
- Raw water
- Purified water (PW)
- Water for injection (WFI)
- Reverse osmosis (RO)
- Electro-deionization (EDI)
- Vapour compression (VC)
- Ultrafiltration
- Deionization
- Heating steam
- Chilled water
- Compressed air
- Sewage system
- Exhaust air
- Sanitization strategy
- Water-treatment equipment
- Water purification equipment, storage and distribution systems
- Hygienic or sanitary design
- Corrosion resistance
- Freedom from leakage
- Configuration
- Proliferation
- Desalinization
- Ion exchange
- Filtration
- Softening
- Disinfection
- Sanitization
- Iron removal
- Precipitation
- Downstream treatment stages
- Upstream treatment stages
- Distribution pipework
- Flush
- Sanitize
- Prevented vents
- Microbiological contamination
- Ultraviolet disinfection
- Thermal sanitization
- Stainless steel (at least grade 316)
- Roughness (average surface roughness, not greater than 0.8 micrometre (RA)
- Crevices
- Electro-polishing techniques
- Proportion of welds (e.g.: 100% hand welds, 10% automatic welds)
- Flange, union and valves
- Diaphragms
- Material certificates
- Polypropylene
- Polyvinylidene-difluoride
- Perfluoroalkoxy
- Spray ball
- Headspace
- Droplets
- Nozzles
- Vent filter
- Storage tank
- Distribution loop
- Stand-by pump (avoid dead zones)
- Stagnant water
- Turbulent flow circulation
- Biofilm
- Deadlegs (not exceed 3times the branch diameter, 3D)
- Pressure gauges
- Membrane
- Hygienic pattern diaphragm valves
- Slope
- Drainable
- PQ Phase 1, 2weeks, phase 2, 2 weeks, phase 3, one year.
- Continuous system monitoring
- Log books
- P&ID: piping and instrumentation diagram or drawing
4. General words for QC Laboratory
- Characteristics
- Accuracy
- Precision
n Repeatability (precision under the same operating conditions over a short period of time)
n Intermediate precision (within one laboratory, different dates, different analyst or different instruments)
n Reproducibility (precision between laboratories)
- Specificity
- Detection limit
- Quantitation limit
- Linearity
- Range
- Pharmacopoeia methods
- Garment
- Top-loading balance
- Analytical balance (5 digits)
- Melting-point apparatus
- pH meter (with assorted electrodes)
- microscope
- polarimeter
- high-performance liquid chromatograph with ultraviolet detector
- ultraviolet/visible spectrophotometer
- infrared spectrophotometer with pellet press
- Karl Fischer titrator (semi-micro determination of water)
- Agate mortar with pestle
- Equipment for thin-layer chromatography
- Thin-layer chromatography spotter
- Developing chambers
- Atomizers
- Ultraviolet viewing lamp
- Potentiometric titrimeter
- Micro-Kjeldahl equipment (including fume flasks)
- Disintegration test equipment (1 basket for 6 tablets)
- Dissolution apparatus
- Soxhlet extraction apparatus (60ml)
- Micrometer calipers
- Pycnometer
- Burette /pipettes (10ml and 25ml/1,2,5,10,20, 25, 50ml)
- Heating mantles for flasks (assorted sizes: 50, 200 and 2000ml)
- Sieves (assorted sizes)
- Desiccator
- Centrifuge (table-top model, 4-place swing rotor)
- Centrifuge (floor model)
- Water-batch (20 litres)
- Hot plates with magnetic stirrers
- Vacuum pump (rotary, oil)
- Vacuum rotary evaporator
- Drying oven (60 litres)
- Vacuum oven (17 litres)
- Muffle furnace (23 litres)
- Refrigerator (explosion-proof)
- Freezer
- Water distilling apparatus (8 litres/hour)
- Water deionizer (10 litres/hour)
- Dehumidifier (where needed)
- Fume hood
- Analytical microbalance
- Flame photometer (including air compressor)
- Refractometer
- Viscometer
- Vortex mixer
- Shaker (wrist-action)
- Pipette rinser
- Constant temperature water-bath
- Ultrasonic cleaner (5 litres)
- Laboratory glassware washing machine
- Gas chromatograph (flame ionization, direct and static head space injection)
- Oxygen flask combustion apparatus
- Atomic absorption spectrophotometer
- Spectrofluorometer
- High-performance liquid chromatograph detectors:
n Fluorescence
n Diode-array
n Refractive index
n Evaporative light scattering (ELSD)
n Charged aerosol (CAD)
n Mass spectrometric (MS)
- Gas chromatograph detectors:
n Conductivity
n Nitrogen/phosphorous (NPD)
n Mass spectrometric (MS)
- Capillary electrophoresis equipment
- Thin-layer chromatography scanner
- Crushing strength tester
- Friability tester
- Ice machine
- Solvent-recovery apparatus
Equipment for microbiology unit
- pH meter
- ultraviolet/visible spectrophotometer, single-beam
- microscope（for bacteriology）
- membrane filter assembly for sterility tests
- colony counter with magnifier
- laminar air flow unit
- hot-air sterilizer
- incubators, 60 litres
- Anaerobic jar
- Zone reader
- Centrifuge
- Water-bath (thermostatically controlled)
- Autoclaves (100 litres, top-loading)
- Refrigerators (340 litres)
- Deep freeze
- Laboratory glassware washing machine
- Garment
- Settle (exposure) plates
- Surface contact
- Swabs
- Flexible film
- Volumetric equipment (automatic dispensers, dispenser/diluter, mechanical hand pipettes, disposable pipettes)
- Reference thermometers
- Reference thermocouples
- Timers
5. General words for HVAC system
- Airborne particles
- Occupancy states (as-build, at-rest, operational)
- Particle size
- Minimum number of sampling locations to be tested (NL)
- LSAPC, light scattering particle counter
- Level 1, general area, e.g.: warehouse; Primary filter, G4 filters
- Level 2, protected area, e.g.: secondary packaging, first stage change rooms, Primary plus secondary filters, G4 plus F8 or F9 filters
- Level 3, controlled area, e.g.: area of product exposed to room environment., Primary plus secondary plus tertiary filters, G4 plus F8 or F9 plus H13 filters.
- Horizontal and vertical unidirectional flow
- Ceilings
- Walls
- Building management system (BMS)
- Building automation system (BAS)
- System control and data acquisition (SCADA) system
- Interlocking system
- Warning system
- Airlock
- Air break
- Backflow
- Sink
- drains
- Fresh air
- Return air
- Frost coil
- Reheater
- Automatic air volume control devices
- Sound attenuators
- Snow eliminator
- Dust eliminator
- Air inlet
- Moisture eliminator
- User requirement specifications (URS)
- Relative humidity
- Supply air quantities for all diffusers
- Return air or exhaust air quantities
- Room air change rates
- Room pressures （pressure differentials）
- Room airflow patterns
- Unidirectional flow velocities
- Containment system velocities
- HEPA filter penetration tests
- Room particles counts
- Room clean-up rates
- Particle count test
- Cleanliness
- Filter leakage tests
- Containment leakage
- Recovery
- Operating and maintenance
- Headgear
- Beard
- Moustache
- Neck
- Face mark
- Shedding
- Droplets
- Footwear
- Garment
- Plastic gloves
- Working session
- Fiber
- Exposed surfaces
- Accumulation of particles or micro-organisms
- Cleaning agents
- Disinfectant
- Uncleanable recesses
- Projecting ledges
- Shelves
- Cupboards
- Changing rooms
- Hand washing facilities
- Simultaneously
- Positive pressure
- Flush
- Adjacent rooms
- Pressure differential of 10-15 pascals
- Air-flow patterns
- Conveyor belt
- Pass through
- Fumigation
- Validated loading patterns
- Biological indicators
- Tray