<\/p>\n
AADA: Abbreviated antibiotic drug application
\nADE: Adverse drug event
\nADME: Absorption, distribution, metabolism, and excretion
\nAHU: Air Handling Unit
\nANDA: Abbreviated new drug application
\nANVISA: Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (National Health
\nSurveillance Agency Brazil)
\nAP: Applicants Part (of EDMF)
\nAPI: Active pharmaceutical ingredient
\nAPR: Annual product review (APQR \u2013 Annual product quality
\nreview)
\nAQL: Acceptable quality level
\nAR: Analytical Reagent
\nASHRAE: American Society of heating, Refrigeration and
\nAir Conditioning Engineers
\nASM: Active Substance Manufacturer
\nASMF: Active Substance Master File
\nAST: Accelerated stability testing
\nASTM: American Society for Testing and Materials
\nBA\/BE: Bioavailability\/bioequivalence
\nBCS: Biopharmaceutical classification system
\nBET: Bacterial Endotoxins Test
\nBFS: Blow Fill Seal
\nBI: Biological Indicator
\nBMR: Batch Manufacturing\/Processing Record<\/p>\n
BOD: Biological Oxygen Demand
\nBOM: Bill of Materials
\nBOPP: Biaxilary Oriented Polypropylene
\nBP: British Pharmacopoeia
\nBPR: Batch Packaging Record
\nBRMS: Biologics Regulatory Management System
\nBSE: Bovine spongiform encephalopathy (mad cow disease)
\nCAPA: Corrective and preventive action
\nCBE: Changes being effected
\nCBER: Center for Biologics Evaluation and Research (FDA)
\nCCIT: Container closure integrity test
\nCDER: Center for Drug Evaluation and Research (FDA)
\nCDSCO: Central drug standard control organization (India)
\nCEP: Certification of suitability of European Pharmacopoeia monographs
\nCFR: Code of Federal Regulations
\nCFU: Colony Forming Unit
\ncGMP: Current Good Manufacturing Practices
\nCIP: Clean in place
\nCMC: Chemistry, manufacturing and controls
\nCMS: Continuous monitoring system
\nCOA: Certificate of analysis
\nCOS: Certificate of suitability
\nCOPP: Certificate of Pharmaceutical Products
\nCPP: Critical Process Parameter
\nCQA: Critical Quality Attribute
\nCTD: Common technical document
\nDMF: Drug master file
\nDOP: Dioctyl Phthalate
\nDQ: Design Qualification
\nEDMF: European drug master file
\nEDQM: European Directorate for the Quality of Medicines
\nEH&S: Environmental health and safety
\nEIR: establishment inspection report (FDA)
\nEMEA: European Medicines Agency (formerly European Medicines Evaluation Agency)
\nEP: European Pharmacopoeia
\nEPS: Expanded polystyrene
\nETP: Effluent Treatment Plant
\nEU: Endotoxins unit<\/p>\n
EU: European Union
\nFAT: Factory Acceptance Testing
\nFBD: Fluid-bed dryer
\nFDA: Food and Drug Administration, United States
\nFDC: Fixed Dose Combination
\nFEFO: First expiry first out
\nFG: Finished Goods
\nFIFO: First in first out
\nFMEA: Failure modes and effect analysis
\nFOI: Freedom of information
\nGAMP: Good automated manufacturing practice
\nGC: Gas Chromatography
\nGCLP: Good clinical laboratory practice
\nGCP: Good clinical practice
\nGDP: Good distribution practice
\nGEP: Good engineering practice
\nGGP: good guidance practice
\nGIT: Gastrointestinal Tract
\nGLP: Good laboratory practice
\nGMO: Genetically modified organism
\nGMP: Good manufacturing practice
\nGPT: Growth Promotion Test
\nGRAS\/E: Generally recognized as safe and effective<\/p>\n
GRP: Good review practice
\nHACCP: Hazard analysis critical control point
\nHDPE: High Density Polyethylene
\nHEPA: High efficiency particulate air (filter)
\nHPLC: High performance liquid chromatography
\nHSA: Health Sciences Authority, Singapore
\nHVAC: Heating, ventilating, and air conditioning
\nICAH: International Conference on Harmonization
\nIH: In house
\nIM: Intramuscular
\nIND: Investigational new drug
\nINDA: Investigational new drug application
\nIP: Indian Pharmacopeia
\nIPA: Isopropyl Alcohol
\nIPS: In process control
\nIQ: Installation qualification<\/p>\n
IR: Immediate release
\nISO: International Organization for Standardization
\nISPE: International Society for Pharmaceutical Engineering
\nIV: Intravenous
\nJP: Japanese Pharmacopoeia
\nKOS: Knowledge organization system
\nLAF: Laminar air flow
\nLAL: Limulus Amoebocyte Lysate
\nLD: Lethal dose
\nLD50: Lethal dose where 50% of the animal population die
\nLDPE: Low Density Polyethylene
\nLIMS: Laboratory Information Management System
\nLIR: Laboratory Investigation Report
\nLOD: Loss on drying
\nLOD: Limit of detection
\nLOQ: Limit of quantification
\nLR: Laboratory Reagent
\nLVPs: Large Volume Parenteral
\nMA: Marketing Authorization
\nMAA: Marketing Authorization Application
\nMAC: Maximum Allowable Carryover
\nMCC: Medicines control council (South Africa)<\/p>\n
MFR: Master Formula Record
\nMEDSAFE: Medicines and medicinal devices safety authority (New Zealand)
\nMHRA: Medicines and Healthcare products Regulatory Agency (UK)
\nMOA: Method Of Analysis
\nMSDS: Material Safety Data Sheets
\nNCE: New chemical entity
\nNDA: New Drug Application
\nNF: National Formulary
\nNIR: Near Infra Red Spectroscopy
\nNON: Notice of non-compliance (Canada)
\nODI: Orally Disintegrating Tablet
\nOQ: Operation Qualification
\nOSD: Oral Solid Dosage
\nOSHA: Occupational Safety And Health Administration
\nOTC: Over-the-counter<\/p>\n
OOS: Out of specification
\nOOT: Out of trend
\nPAC: Post-approval changes
\nPAO: Poly alpha olefin
\nPAT: Process Analytical technology
\nPET: Preservative efficacy test
\nPET: Polyethylene
\nPIC\/S: Pharmaceutical Inspection Co-operation Scheme
\nPLC: Programmable Logic Control
\nPQ: Performance Qualification
\nPVC: Polyvinyl Chloride
\nPVDC: Polyvinylidene Chloride
\nPW: Purified Water
\nQA : Quality Assurance
\nQC: Quality Control
\nQBD: Quality by design
\nQM: Quality Manual
\nQSD: Quality System Dossier
\nQSM : Quality System Management
\nQMS: Quality Management System
\nRH: Relative humidity
\nRLAF: Reverse laminar air flow<\/p>\n
RLD: Reference listed drug
\nRM: Raw material
\nRO: Reverse Osmosis
\nROPP: Roll On Pilfer Proof
\nRS: Related Substance
\nSAL: Sterility Assurance Level
\nSAT: Site Acceptance Testing
\nSDN: Screening Deficiency Notice (Canada)
\nSIP: Sterilization in place\/Steam in place
\nSLS: Sodium Lauryl Sulphate
\nSMF: Site master file
\nSOP: Standard operating procedure
\nSPE: Society for Pharmaceutical Engineering
\nSUPAC: Scale-up and post approval changes
\nSVP: Small Volume Parenteral
\nTC: Thermocouple
\nTDS: Total Dissolved Solids<\/p>\n
TGA: Therapeutics goods administration (Australia)
\nTOC: Total organic carbon
\nTSE: Transmissible spongiform encephalopathy
\nUSFDA: United states foods and drugs administration
\nUSP: United States Pharmacopeia
\nUSP-NF: United States Pharmacopeia-National Formulary
\nURS: User Requirement Specification
\nVAI: Voluntary action indicated
\nVMP: Validation Master Plan
\nWFI: Water for injection
\nWHO: World Health Organization
\nWL: Warning letter<\/p>\n
<\/p>\n
<\/p>\n","protected":false},"excerpt":{"rendered":"
PHARMA ABBREVIATIONS AADA: Abbreviated antibiotic drug application ADE: Adverse drug event ADME: Absorption, distribution, metabolism, and excretion AHU: Air Handling Unit ANDA: Abbreviated new drug application ANVISA: Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (National Health Surveillance Agency Brazil) AP: Applicants Part (of EDMF) API: Active pharmaceutical ingredient APR: Annual product review (APQR \u2013 Annual product […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[38],"tags":[],"class_list":["post-1951","post","type-post","status-publish","format-standard","hentry","category-pharma-definition-abbreviation"],"_links":{"self":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/1951","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1951"}],"version-history":[{"count":2,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/1951\/revisions"}],"predecessor-version":[{"id":1953,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=\/wp\/v2\/posts\/1951\/revisions\/1953"}],"wp:attachment":[{"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1951"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1951"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmacoguide.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1951"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}