Abbreviations data base is the best available abbreviation collection which extensively lists out common and useful acronyms and abbreviations related to the pharmaceutical industry.
This collection includes, abbreviations connected with Regulatory affairs, Pharmacovigilance (PV), Clinical trials, cGMP, Quality Assurance, Quality Control etc.
This data base is updated on regular basis (last updated on 10th March 2020) to catch up new terminologies.
AADA: | Abbreviated Antibiotic Drug Application |
AAO: | American Academy of Ophthalmology |
ADE: | Adverse Drug Event |
ADME: | Absorption, Distribution, Metabolism, and Excretion |
ADI: | Acceptable Daily Intake |
ADR: | Adverse Drug Reaction |
ADRS: | Adverse Drug Reporting System |
AGDUFA: | Animal Generic Drug User Fee Act |
AHU: | Air Handling Unit |
ALCOA: | Acronym referring to Attributable, Legible, Contemporaneous, Original and Accurate. |
ALCOA PLUS: | Acronym referring to Attributable, Legible, Contemporaneous, Original and Accurate ‘plus’ Complete, Consistent, Enduring, and Available. |
AME: | Absorption, Metabolism, Excretion |
ANDA: | Abbreviated New Drug Application |
ANOVA: | Analysis of Variance |
ANVISA: | Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil) |
AP: | Applicants Part (of EDMF) |
API: | Active Pharmaceutical Ingredient |
APIC: | Active Pharmaceutical Ingredients Committee |
APR: | Annual product review (APQR – Annual product quality review) |
AQL: | Acceptable Quality Level |
AR: | Analytical Reagent |
ARB: | Angiotensin Receptor Blocker |
ASHRAE: | American Society of heating, Refrgeration and Air Conditioning Engineers |
ASM: | Active Substance Manufacturer |
ASME: | American Society of Mechanical Engineers |
ASMF: | Active Substance Master File |
ASQ: | American Society for Quality |
AST: | Accelerated Stability Testing |
ASTM: | American Society for Testing and Materials |
BA/BE: | Bioavailability/Bioequivalence |
BCS: | Biopharmaceutical Classification System |
BET: | Bacterial Endotoxin Test |
BFS: | Blow Fill Seal |
BI: | Biological Indicator |
BIND: | Biological Investigational New Drug |
BLA: | Biologics License Application (CBER) |
BMI: | Body Mass Index |
BMR: | Batch Manufacturing/Processing Record |
BOD: | Biological Oxygen Demand |
BOM: | Bill of Materials |
BOPP: | Biaxially Oriented Polypropylene |
BP: | British Pharmacopoeia |
BPC: | Bulk Pharmaceutical Chemical |
BPR: | Batch Packaging Record |
BRMS: | Biologics Regulatory Management System |
BSA: | Body Surface Area |
BSE: | Bovine Spongiform Encephalopathy (Mad Cow Disease) |
BSI: | British Standards Institute |
BST: | Bovine Somatotropin |
BsUFA: | Biosimilar User Fee Act |
BTD: | Breakthrough Therapy Designation |
BVC: | British Veterinary Codex |
CA: | Chemical Abstracts |
CAPA: | Corrective and preventive action |
CANDA: | Computer Assisted New Drug Application |
CAPLA: | Computer Assisted Product License Application |
CAS: | Chemical Abstracts Service |
CBE: | Changes Being Effected |
CBER: | Center for Biologics Evaluation and Research (FDA) |
CCIT: | Container Closure Integrity Test |
CDER: | Center for Drug Evaluation and Research (FDA) |
CDRH: | Center for Devices and Radiological Health (FDA) |
CDSCO: | Central Drug Standard Control Organization (India) |
CEP: | Certification of Suitability of European Pharmacopoeia Monographs |
CFR: | Code of Federal Regulations |
CFU: | Colony Forming Unit |
CJD: | Creutzfeldt Jakob Disease |
cGMP: | Current Good Manufacturing Practices |
CIP: | Clean in Place |
CMC: | Chemistry, Manufacturing and Controls |
CMO: | Contract Manufacturing Organization |
CMS: | Continuous Monitoring System |
CNS: | Central Nervous System |
COA: | Certificate of Analysis |
COI: | Conflict of Interest |
COMSTAT: | Compliance Status Information System |
COP: | Clean out of Place |
COPP: | Certificate of Pharmaceutical Products |
CoS: | Certificate of Suitability |
CPI: | Consumer Price Index |
CPP: | Critical Process Parameter |
CQA: | Critical Quality Attribute |
CR: | Complete Response (Letter) |
CRO: | Contract Research Organization |
CRS: | Contamination Response System |
CSA: | Controlled Substances Act |
CSV: | Computer System Validation |
CT: | Clinical Trial |
CTD: | Common Technical Document |
CVMP: | Committee on Veterinary Medical Products (EMA) |
DI: | Deionized Water |
DIN: | Drug Identification Number (Canada) |
DMF: | Drug Master File |
DOA: | Drugs of Abuse |
DOE: | Design of Experiment |
DOP: | Dioctyl Phthalate |
DQ: | Design Qualification |
DP: | Drug Product |
DPC-PTR Act: | Drug Price Competition and Patent Trade Restoration Act of 1984 |
DPI: | Dry Powder Inhaler |
DS: | Drug Substance |
DUNS: | Data Universal Numbering System |
EC: | European Community |
ED: | Effective Dose |
EDMF: | European Drug Master File |
EDQM: | European Directorate for the Quality of Medicines |
EFOIA: | Electronic Freedom of Information Act |
EFPIA: | European Federation of Pharmaceutical Industries and Associations |
EFTA: | European Free Trade Association |
EH&S: | Environmental Health and Safety |
EIA: | Enzyme Immunoassay |
EIR: | Establishment Inspection Report (FDA) |
EMA: | European Medicines Agency (Formerly European Medicines Evaluation Agency -EMEA) |
EP: | European Pharmacopoeia |
EPAR: | European Public Assessment Reports (EMEA) |
EPS: | Expanded Polystyrene |
ERP: | Emergency Response Plan |
ERS: | Electronic Regulatory Submission |
ERSR: | Electronic Regulatory Submissions and Review |
ESG: | Electronic Submissions Gateway |
ETP: | Effluent Treatment Plant |
EU: | Endotoxin Unit |
EU: | European Union (EU 27) |
FAI: | Further Action Indicated (FDA) |
FAR: | Field Alert Report (FDA) |
FAT: | Factory Acceptance Testing |
FBD: | Fluid-Bed Dryer |
FDA: | Food and Drug Administration, United States |
FDA Form 482: | FDA form for Notice of Inspection |
FDA-483: | FDA form Used as a Written Notice of Deficiencies Found in Inspections |
FDA-SRS: | Spontaneous Reporting System of the Food and Drug Administration |
FDC: | Food, Drug, & Cosmetic |
FDC: | Fixed Dose Combination |
FDCA: | Federal Food, Drug, and Cosmetic Act of 1938 |
FFDCA: | Federal Food, Drug, and Cosmetic Act of 1938 |
FEI: | Facility Establishment Identifier |
FEFO: | First Expiry First Out |
FG: | Finished Goods |
FIFO: | First in First Out |
FMEA: | Failure Modes and Effect Analysis |
FMECA: | Failure Modes Effects and Criticality Analysis |
FOI: | Freedom of Information |
FOIA: | Freedom of Information Act |
FR: | Federal Register |
FTA: | Fault Tree Analysis |
GAMP: | Good Automated Manufacturing Practice |
GARR: | Grants Application Review Request |
GC: | Gas Chromatography |
GCLP: | Good Clinical Laboratory Practice |
GCLP: | Good Clinical laboratory practice |
GCP: | Good Clinical practice |
GDP: | Good Distribution practice |
GEO: | Genetically Engineered Organism |
GEP: | Good Engineering Practice |
GGP: | Good Guidance practice |
GIT: | Gastrointestinal Tract |
GLP: | Good Laboratory Practice |
GMO: | Genetically Modified Organism |
GMP: | Good Manufacturing Practice |
GPT: | Growth Promotion Test |
GRAS: | Generally Recognized as Safe |
GRAS/E: | Generally Recognized as Safe and Effective |
GRP: | Good Review Practice |
GUDUFA: | Generic Drug User Fee Amendments |
GxP: | "Good x"" Practices |
HACCP: | Hazard Analysis Critical Control Point |
HCI: | Human-Computer Interaction |
HDPE: | High Density Polyethylene |
HEPA: | High Efficiency Particulate Air (filter) |
HMI: | Human Machine Interface |
HPLC: | High Performance Liquid Chromatography |
HSA: | Health Sciences Authority, Singapore |
HVAC: | Heating, Ventilating, and Air Conditioning |
ICAH: | International Council on Harmonisation (Formally known as International Conference on Harmonisation) |
IH: | In House |
IM: | Intramuscular |
IND: | Investigational New Drug |
INDA: | Investigational New Drug Application |
INN: | International Nonproprietary Name |
IP: | Indian Pharmacopeia |
IPA: | Isopropyl Alcohol |
IPC: | In process Control |
IPCS: | International Programme on Chemical Safety (WHO) |
IPEC: | International Pharmaceutical Excipients Council |
IQ: | Installation Qualification |
IR: | Immediate Release |
IR: | Information Request (Letter) |
ISO: | International Organization for Standardization |
ISPE: | International Society for Pharmaceutical Engineering |
IUPAC: | International Union of Pure and Applied Chemistry |
IV: | Intravenous |
JP: | Japanese Pharmacopoeia |
KOS: | Knowledge Organization System |
LAF: | Laminar air flow |
LAL: | Limulus Amoebocyte Lysate |
LAN: | Local Area Network |
LD: | Lethal Dose |
LD50: | Lethal Dose where 50% of the Animal Population Die |
LDPE: | Low Density Polyethylene |
LIMS: | Laboratory Information Management System |
LIR: | Laboratory Investigation Report |
LOA: | Letter of Agreement |
LOA: | Letter of Authorization |
LOD: | Loss on Drying |
LOD: | Limit of Detection |
LOQ: | Limit of Quantification |
LR: | Laboratory Reagent |
LVPs: | Large Volume Parenterals |
MA: | Marketing Authorisation |
MAA: | Marketing Authorisation Application |
mAb: | Monoclonal Antibody |
MAC: | Maximum Allowable Carryover |
MAH: | Marketing Authorisation Holder (EC) |
MDA: | Medical Devices Agency (UK) |
MDD: | Maximum Daily Dose |
MDI: | Metered Dose Inhaler |
MDR: | Medical Device Reporting |
MDUFMA: | Medical Device User Fee and Modernization Act of 2002 |
MDUFSA: | Medical Device User Fee Stabilization Act of 2005 |
MFR: | Master Formula Record |
MEDSAFE: | Medicines and Medicinal Devices Safety Authority (New Zealand) |
MHRA: | Medicines and Healthcare Products Regulatory Agency (UK) |
MLD: | Minimum Lethal Dose |
MOA: | Method Of Analysis |
MRA: | Mutual Recognition Agreement |
MS: | Mass Spectroscopy |
MSDS: | Material Safety Data Sheets |
MTD: | Maximum Tolerated Dose |
NCE: | New Chemical Entity |
NAI: | No Action Indicated(FDA) |
NCR: | Non-Conformance Report |
NDA: | New Drug Application |
NDC: | National Drug Code (FDA) |
NF: | National Formulary |
NIR: | Near Infra Red Spectroscopy |
NME: | New Molecular Entity |
NMR: | Nuclear Magnetic Resonance Spectroscopy |
NMT: | Not More Than |
NOAEL: | No Observable Adverse Effect Level |
NOC: | Notice of Compliance (Canada) |
NOD: | Notice of Deficiency (Canada |
NON: | Notice of Non-compliance (Canada) |
NSAID: | Non-Steroidal Anti-Inflammatory Drug |
OAI: | Official Action Indicated(FDA) |
ODI: | Orally Disintegrating Tablet |
OEL: | Occupational Exposure Level |
OQ: | Operation Qualification |
OSD: | Oral Solid Dosage |
OSHA: | Occupational Safety And Health Administration |
OOS: | Out of Specification |
OOT: | Out of Trend |
OTC: | Over-the-counter |
PAC: | Post-approval changes |
PACT: | Post-Approval Commitment Tracking |
PAI: | Pre-Approval Inspection(FDA) |
PAO: | Poly alpha olefin |
PAS: | Prior Approval Supplement(FDA) |
PAT: | Process Analytical technology |
PD: | Pharmacodynamics |
PDA: | Parenteral Drug Association |
PDE: | Permitted Daily Exposure |
PDUFA: | Prescription Drug User Fee Act |
PEPFAR: | Presidential Emergency Plan for AIDS Relief |
PET: | Preservative Efficacy Test |
PET: | Polyethylene |
Ph.Eur.: | Pharmacopeia Europa |
PIC/S: | Pharmaceutical Inspection Co-operation Scheme |
PK: | Pharmacokinetics |
PLA: | Product License Application (CBER) |
PLAIR: | Pre-Launch Activities Importation Request (USFDA) |
PLC: | Programmable Logic Control |
PMA: | Premarket Approval |
PMF: | Public Master File |
PMS: | Postmarketing Surveillance |
POM: | Prescription-only medicine (UK) |
ppb: | Parts per Billion |
PPE: | Personal protective equipment |
Ppm: | Parts per Million |
PPM: | Planned Preventive Maintenance |
PQ: | Performance Qualification |
PQG: | Pharmaceutical Quality Group |
PUDUFA: | Prescription Drug User Fee Act (FDA) |
PV: | Process Validation |
PVC: | Polyvinyl Chloride |
PVDC: | Polyvinylidene Chloride |
PW: | Purified Water |
QA : | Quality Assurance |
QC: | Quality Control |
QbD: | Quality by design |
QbR: | Question-based Review |
QD: | Once Daily |
QID: | Four Times a Day |
QM: | Quality Manual |
QMS: | Quality Management System |
QOD: | Every Other Day |
QP: | Qualified Person (EU) |
QRM: | Quality Risk Management |
QSD: | Quality System Dossier |
QSM: | Quality System Management |
QU: | Quality Unit |
RCR: | Risk Control Review |
R&D: | Research and Development |
REMS: | Risk Evaluation and Mitigation Strategy |
RH: | Relative Humidity |
RLAF: | Reverse Laminar Air Flow |
RLD: | Reference listed drug |
RM: | Raw Material |
RMS: | Reference Member State (Europe) |
RO: | Reverse Osmosis |
ROPP: | Roll On Pilfer Proof |
RS: | Related Substance |
RTR: | Refuse to Receive |
Rx: | Prescription |
SAL: | Sterility Assurance Level |
SAT: | Site Acceptance Test |
SDN: | Screening Deficiency Notice (Canada) |
SHPRA | South African Health Products Authority [formally known as Medicines Control Council (MCC)] |
SIP: | Sterilization in lace/Steam in place |
SLS: | Sodium Lauryl Sulphate |
SME: | Subject Matter Expert |
SMF: | Site Master File |
SOP: | Standard Operating Procedure |
SPE: | Society for Pharmaceutical Engineering |
STD: | Sexually Transmitted Disease |
SUPAC: | Scale-up and Post Approval Changes |
SVP: | Small Volume Parenteral |
TC: | Thermocouple |
TDI: | Tolerable Daily Intake |
TDS: | Total Dissolved Solids |
TGA: | Therapeutics Goods Administration (Australia) |
TLC: | Thin Layer Chromatography |
TID: | Three Times a Day |
TOC: | Total Organic Carbon |
TSE: | Transmissible Spongiform Encephalopathy |
UDI: | Unique Device Identification |
UNII: | Unique Ingredient Identifier |
USFDA: | United States Foods and Drugs Administration |
USP: | United States Pharmacopeia |
USPC: | U.S. Pharmacopeial Convention |
USP-NF: | United States Pharmacopeia-National Formulary |
URS: | User Requirement Specification |
UTI: | Urinary tract infection |
VAI: | Voluntary Action Indicated |
VMP: | Validation Master Plan |
WFI: | Water for Injection |
WHO: | World Health Organisation |
WL: | Warning letter |
No comments:
Post a Comment