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: Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil)

AP: Applicants Part (of EDMF)

API: Active pharmaceutical ingredient

APR: Annual product review (APQR – Annual product quality

         review)

AQL: Acceptable quality level

AR: Analytical Reagent

ASHRAE: American Society of heating, Refrgeration and

 Air Conditioning Engineers

ASM: Active Substance Manufacturer

ASMF: Active Substance Master File

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

BMR: Batch Manufacturing/Processing Record

BOD: Biological Oxygen Demand

BOM: Bill of Materials

BOPP: Biaxially Oriented Polypropylene

BP: British Pharmacopoeia

BPR:  Batch Packaging Record

BRMS: Biologics Regulatory Management System

BSE: Bovine spongiform encephalopathy (mad cow disease)

CAPA: Corrective and preventive action

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)

CDSCO: Central drug standard control organization (India)

CEP: Certification of suitability of European Pharmacopoeia monographs

CFR: Code of Federal Regulations

CFU: Colony Forming Unit

cGMP: Current Good Manufacturing Practices

CIP: Clean in place

CMC: Chemistry, manufacturing and controls

CMS: Continuous monitoring system

COA: Certificate of analysis

COS: Certificate of suitability

COPP: Certificate of Pharmaceutical Products

CPP: Critical Process Parameter

CQA: Critical Quality Attribute

CTD: Common technical document

DMF: Drug master file

DOP: Dioctyl Phthalate

DQ: Design Qualification

EDMF: European drug master file

EDQM: European Directorate for the Quality of Medicines

EH&S: Environmental health and safety

EIR: establishment inspection report (FDA)

EMEA: European Medicines Agency (formerly European Medicines Evaluation Agency)

EP: European Pharmacopoeia

EPS: Expanded polystyrene

ETP: Effluent Treatment Plant

EU: Endotoxin unit

EU: European Union

FAT: Factory Acceptance Testing

FBD: Fluid-bed dryer

FDA: Food and Drug Administration, United States

FDC: Fixed Dose Combination

FEFO: First expiry first out

FG: Finished Goods

FIFO: First in first out

FMEA: Failure modes and effect analysis

FOI: Freedom of information

GAMP: Good automated manufacturing practice

GC: Gas Chromatography

GCLP: Good clinical laboratory practice

GCP: Good clinical practice

GDP: Good distribution practice

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/E: Generally recognized as safe and effective

GRP: Good review practice

HACCP: Hazard analysis critical control point

HDPE: High Density Polyethylene

HEPA: High efficiency particulate air (filter)

HPLC: High performance liquid chromatography 

HSA: Health Sciences Authority, Singapore

HVAC: Heating, ventilating, and air conditioning

ICAH: International Conference on Harmonisation

IH: In house

IM: Intramuscular

IND: Investigational new drug

INDA: Investigational new drug application

IP: Indian Pharmacopeia

IPA: Isopropyl Alcohol

IPS: In process control

IQ: Installation qualification

IR: Immediate release

ISO: International Organization for Standardization

ISPE: International Society for Pharmaceutical Engineering

IV: Intravenous

JP: Japanese Pharmacopoeia

KOS: Knowledge organization system

LAF: Laminar air flow

LAL:  Limulus Amoebocyte  Lysate

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

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

MAC: Maximum Allowable Carryover

MCC: Medicines control council (South Africa)

MDD: Maximum daily dose

MFR: Master Formula Record

MEDSAFE: Medicines and medicinal devices safety authority (New zealand)  

MHRA: Medicines and Healthcare products Regulatory Agency (UK)

MOA: Method Of Analysis

MSDS: Material Safety Data Sheets

NCE: New chemical entity

NDA: New Drug Application

NF: National Formulary

NIR: Near Infra Red Spectroscopy

NON: Notice of non-compliance (Canada)

ODI: Orally Disintegrating Tablet

OQ: Operation Qualification

OSD: Oral Solid Dosage

OSHA: Occupational Safety And Health Administration

OTC: Over-the-counter

OOS: Out of specification

OOT: Out of trend

PAC: Post-approval changes

PAO: Poly alpha olefin

PAT: Process Analytical technology

PET: Preservative efficacy test

PET: Polyethylene

PIC/S:  Pharmaceutical Inspection Co-operation Scheme

PLC:  Programmable Logic Control

PQ: Performance Qualification

PVC: Polyvinyl Chloride

PVDC: Polyvinylidene Chloride

PW: Purified Water

QA :  Quality Assurance

QC:  Quality Control

QbD: Quality by design

QM: Quality Manual

QSD:  Quality System Dossier

QSM : Quality System Management

QMS: Quality Management System

RH: Relative humidity

RLAF: Reverse laminar air flow

RLD: Reference listed drug

RM: Raw material

RO: Reverse Osmosis

ROPP: Roll On Pilfer Proof

RS: Related Substance

SAL: Sterility Assurance Level

SAT: Site Acceptance Testing

SDN: Screening Deficiency Notice (Canada)

SIP: Sterilization in place/Steam in place

SLS: Sodium Lauryl Sulphate

SMF: Site master file

SOP: Standard operating procedure

SPE:  Society for Pharmaceutical Engineering

SUPAC: Scale-up and post approval changes

SVP:  Small Volume Parenteral

TC: Thermocouple

TDS: Total Dissolved Solids

TGA: Therapeutics goods administration (Australia)

TOC: Total organic carbon

TSE: Transmissible spongiform encephalopathy

USFDA: United states foods and drugs administration

USP: United States Pharmacopeia

USP-NF: United States Pharmacopeia-National Formulary

URS: User Requirement Specification

VAI: Voluntary action indicated

VMP: Validation Master Plan

WFI: Water for injection

WHO: World Health Organisation

WL: Warning letter