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ABBREVIATION: Abbreviation
is an shortened form of an word, the most commonly used abbreviations in pharmaceutical company
AADA:
Abbreviated antibiotic drug application
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ADE:
Adverse drug event
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ADME:
Absorption, distribution, metabolism, and excretion
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AHU: Air
Handling Unit
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ANDA:
Abbreviated new drug application
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ANVISA: Agência
Nacional de Vigilância Sanitária (National Health Surveillance
Agency Brazil)
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AP:
Applicants Part (of EDMF)
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API:
Active pharmaceutical ingredient
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APR:
Annual product review (APQR – Annual product quality
review)
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AQL:
Acceptable quality level
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AR:
Analytical Reagent
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ASHRAE:
American Society of heating, Refrgeration and
Air
Conditioning Engineers
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ASM:
Active Substance Manufacturer
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ASMF:
Active Substance Master File
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AST:
Accelerated stability testing
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ASTM: American
Society for Testing and Materials
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BA/BE:
Bioavailability/bioequivalence
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BCS:
Biopharmaceutical classification system
BDR: Batch
Distribution Record
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BET:
Bacterial Endotoxin Test
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BFS:
Blow Fill Seal
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BI: Biological
Indicator
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BMR: Batch
Manufacturing/Processing Record
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BOD:
Biological Oxygen Demand
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BOM: Bill of
Materials
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BOPP:
Biaxially Oriented Polypropylene
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BP:
British Pharmacopoeia
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BPR: Batch Packaging Record
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BRMS:
Biologics Regulatory Management System
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BSE:
Bovine spongiform encephalopathy (mad cow disease)
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CAPA:
Corrective and preventive action
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CBE:
Changes being effected
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CBER:
Center for Biologics Evaluation and Research (FDA)
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CCIT:
Container closure integrity test
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CDER:
Center for Drug Evaluation and Research (FDA)
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CDSCO: Central drug standard control organization (India)
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CEP:
Certification of suitability of European Pharmacopoeia monographs
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CFR:
Code of Federal Regulations
CFM: Cubic
Feet Per Minute
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CFU: Colony
Forming Unit
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cGMP: Current
Good Manufacturing Practices
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CIP:
Clean in place
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CMC: Chemistry,
manufacturing and controls
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CMS:
Continuous monitoring system
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COA:
Certificate of analysis
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COS:
Certificate of suitability
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COPP:
Certificate of Pharmaceutical Products
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CPP: Critical Process Parameter
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CQA: Critical Quality Attribute
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CTD:
Common technical document
DCP: Di-Basic
Calcium Phosphate
DHA: Decosahexanoic
Acid
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DMF:
Drug master file
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DOP: Dioctyl
Phthalate
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DQ: Design
Qualification
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EDMF:
European drug master file
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EDQM:
European Directorate for the Quality of Medicines
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EH&S: Environmental health and safety
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EIR:
establishment inspection report (FDA)
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EMEA:
European Medicines Agency (formerly European Medicines Evaluation Agency)
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EP:
European Pharmacopoeia
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EPS:
Expanded polystyrene
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ETP:
Effluent Treatment Plant
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EU:
Endotoxin unit
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EU:
European Union
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FAT: Factory
Acceptance Testing
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FBD:
Fluid-bed dryer
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FDA: Food
and Drug Administration, United States
FDAP: Food
and Drugs Administration, Philippines
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FDC:
Fixed Dose Combination
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FEFO:
First expiry first out
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FG:
Finished Goods
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FIFO:
First in first out
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FMEA:
Failure modes and effect analysis
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FOI:
Freedom of information
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GAMP:
Good automated manufacturing practice
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GC:
Gas Chromatography
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GCLP:
Good clinical laboratory practice
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GCP:
Good clinical practice
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GDP:
Good distribution practice
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GEP:
Good engineering practice
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GGP:
good guidance practice
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GIT:
Gastrointestinal Tract
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GLP:
Good laboratory practice
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GMO:
Genetically modified organism
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GMP:
Good manufacturing practice
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GPT: Growth
Promotion Test
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GRAS/E: Generally recognized as safe and effective
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GRP:
Good review practice
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HACCP:
Hazard analysis critical control point
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HDPE: High
Density Polyethylene
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HEPA:
High efficiency particulate air (filter)
HLV:
Hand Level Valve
HMI: Human
Machine Interface
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HPLC:
High performance liquid chromatography
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HSA: Health
Sciences Authority, Singapore
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HVAC:
Heating, ventilating, and air conditioning
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ICH:
International Conference on Harmonization
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IH: In
house
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IM:
Intramuscular
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IND:
Investigational new drug
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INDA:
Investigational new drug application
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IP: Indian
Pharmacopeia
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IPA:
Isopropyl Alcohol
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IPS:
In process control
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IQ:
Installation qualification
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IR:
Immediate release
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ISO:
International Organization for Standardization
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ISPE:
International Society for Pharmaceutical Engineering
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IV:
Intravenous
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JP:
Japanese Pharmacopoeia
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KOS:
Knowledge organization system
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LAF:
Laminar air flow
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LAL: Limulus Amoebocyte Lysate
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LD:
Lethal dose
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LD50:
Lethal dose where 50% of the animal population die
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LDPE: Low
Density Polyethylene
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LIMS:
Laboratory Information Management System
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LIR: Laboratory Investigation Report
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LOD:
Loss on drying
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LOD:
Limit of detection
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LOQ:
Limit of quantification
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LR:
Laboratory Reagent
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LVPs: Large
Volume Parenterals
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MA:
Marketing Authorisation
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MAA:
Marketing Authorisation Application
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MAC: Maximum
Allowable Carryover
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MCC: Medicines
control council (South Africa)
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MDD:
Maximum daily dose
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MFR: Master
Formula Record
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MEDSAFE: Medicines
and medicinal devices safety authority (New zealand)
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MHRA:
Medicines and Healthcare products Regulatory Agency (UK)
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MOA: Method
Of Analysis
MRP: Maximum
Retail Price
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MSDS:
Material Safety Data Sheets
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NCE:
New chemical entity
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NDA:
New Drug Application
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NF:
National Formulary
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NIR: Near
Infra Red Spectroscopy NSF: National sanitation foundation |
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NON:
Notice of non-compliance (Canada)
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ODI: Orally
Disintegrating Tablet
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OQ:
Operation Qualification
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OSD: Oral
Solid Dosage
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OSHA:
Occupational Safety And Health Administration
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OTC:
Over-the-counter
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OOS:
Out of specification
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OOT:
Out of trend
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PAC:
Post-approval changes
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PAO: Poly
alpha olefin
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PAT: Process
Analytical technology
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PET:
Preservative efficacy test
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PET:
Polyethylene
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PIC/S: Pharmaceutical Inspection Co-operation
Scheme
PIS: Product
Information Sheet
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PLC: Programmable Logic Control
PLM: Planetary
Mixer
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PQ:
Performance Qualification
PSI: Pound per Square Inch
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PVC:
Polyvinyl Chloride
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PVDC: Polyvinylidene
Chloride
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PW:
Purified Water
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QA : Quality Assurance
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QC: Quality Control
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QbD:
Quality by design
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QM: Quality
Manual
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QSD: Quality System Dossier
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QSM : Quality
System Management
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QMS: Quality
Management System
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RH:
Relative humidity
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RLAF:
Reverse laminar air flow
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RLD:
Reference listed drug
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RM:
Raw material
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RO: Reverse
Osmosis
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ROPP: Roll On
Pilfer Proof
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RS: Related
Substance
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SAL:
Sterility Assurance Level
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SAT: Site
Acceptance Testing
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SDN:
Screening Deficiency Notice (Canada)
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SIP:
Sterilization in place/Steam in place
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SLS: Sodium
Lauryl Sulphate
SPP: Sodium
Propyl Paraben
SSG: Sodium
Starch Glycolate
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SMF:
Site master file
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SOP:
Standard operating procedure
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SPE: Society for Pharmaceutical Engineering
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SUPAC:
Scale-up and post approval changes
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SVP: Small Volume Parenteral
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TC:
Thermocouple
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TDS: Total
Dissolved Solids
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TGA: Therapeutics
goods administration (Australia)
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TOC:
Total organic carbon
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TSE:
Transmissible spongiform encephalopathy
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USFDA: United states foods and
drugs administration
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USP: United
States Pharmacopeia
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USP-NF: United States Pharmacopeia-National Formulary
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URS: User
Requirement Specification
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VAI:
Voluntary action indicated
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VMP: Validation
Master Plan
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WFI:
Water for injection
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WHO:
World Health Organisation
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WL:
Warning letter
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