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 |


