A
AAMI – Association for the Advancement of Medical Instruments
AAPS – American Association of Pharmaceutical Scientists
ADE – Adverse Drug Event
AE – Adverse Event
AESGP – Association Européenne des Specialités Grand Public
AHU – Air Handling Unit
ANDA – Abbreviated New Drug Application
ANSM – Agence nationale de sécurité du médicament et des produits de santé (formerly AFSSAPS)
AOAC – Association of Analytical Communities
AP – Accredited Person
APEC – Asia-Pasific Economic Cooperation
API – Active Pharmaceutical Ingredient
API – Application Programming Interface
APR – Annual Product Review
APIC – Active Pharmaceutical Ingredients Committee
AQL – Acceptable Quality Level
ATMP – Advanced Therapy Medicinal Products
B Up ↑
BI – Biological Indicator
BET – Bacterial Endotoxin Test
BFS – Blow Fill Seal
BLA – Biological Licence Application
BP – British Pharmacopoeia
BPC – Bulk Pharmaceutical Chemicals
BPTF – Bulk Pharmaceutical Task Force
BSE – Bovine Spongiform Encephalopathy
C Up ↑
CAM – Computer-aided manufacturing
CAPA -Corrective and Preventive Actions
CBE – Change Being Effected
CBER – Center for Biologics Evaluation and Research (FDA)
CC – Change Control
CDER – Center for Drug Evaluation and Research (FDA)
CDRH – Center for Devices and Radiological Health (FDA)
CE – Communaute Européene
CEO – Chief/Corporate Executive Officer
CEFIC – European Chemical Industry Council
CFR – Code of Federal Regulation
CFU – Colony Forming Unit
CGMP – Current Good Manufacturing Practises
CIP – Cleaning In Place
CMO – Contract Manufacturing Organisation
COA – Certificates of Analysis
COTS – Commersially Off The Shelf
CPG – Compliance Policy Guide
CpK – Process Capability Index
CPMP – Committee of Proprietary Medicinal Products (EU)
CPP – Critical Process Parameter
CPV – Continued Process Verification
CPV – Continuous Process Verification
CQA – Critical Quality Attribute
CV – Coefficient of Variation
CVM – Center for Veterinary Medicin (FDA)
CVMP – Committee of Proprietary Veterinary Products (EU)
CRO – Contract Research Organization
CTD – Common Technical Document (Register ICH)
D Up ↑
DHF – Design History File
DHR – Device History Record
DIA – Drug Information Association (USA)
DICE – Division of Industry and Consumer Education (FDA)
DMF – Drug Master File
DMR – Device Master Record
DOE – Design of Experiments
DOP – Dioctylphtalate
DP – Drug Product
DQ – Design Qualification
DS – Drug Substance
DSHEA – Dietary Suplement Health and Education Act (USA)
E Up ↑
EBR – Electronic Batch Record
EDR – Enhanced Design Review
EDQM – European Directorate for the Quality of Medicines
EFCG – European Fine Chemicals Group
EFPIA – European Federation of Pharmaceutical Industries Associations
EGA – European Generics Association
EIR – Establishment Inspection Report
EM – Environmental Monitoring
EMA – European Medicines Agency
EMEA – European Medicines Evaluation Agency (Now EMA)
EO – Ethylene Oxide
EU – European Union
EUR PH (EP) – European Pharmacopoeia (Commission)
F Up ↑
FAT – Factory Acceptance Testing
FDA – Food and Drug Administration (USA)
FD&C – Food, Drug and Cosmetic (Act)
FDIS – Final Draft International Standard
FEDESA – Federation Européenne de la Santé Animale
FEFO – First expired First out
FIFO – First in First out
FMD – Falsified Medicines Directive
FMEA – Failure Mode Effects Analysis
FMECA – Failure Mode Effects and Criticality Analysis
FOIA – Freedom of Information Act
FR – Federal Register
FP – Finished Product
G Up ↑
GAMP – Good Audomated Manufacturing Practice
GCLP – Good Control Laboratory Practices
GCP – Good Clinical Practice
GDP – Good Distribution Practice
GDUFA – Generic Drug User Free Act
GEP – Good Engineering Practice
GHTF – Global Harmonisation Task Force
GMO – Genetically Modified Organisms
GMP – Good Manufacturing Practice
GLP – Good Laboratory Practice (For Safety Evaluation)
GPIA – Generic Pharmaceutical Industry Association
GRAS – Generally Recognized As Safe
GTP – Good Tissue Practice
GUDID – Global Unique Device Identification Database
GXP – Good X Practice, X= L (Laboratory), C (Clinical), M (Manufacturing), D (Distribution) etc.
H Up ↑
HACCP – Hazard Analysis and Critical Control Point
HAZOP – Hazard Operability Analysis
HEPA-FILTER – High Efficiency Particulate Air filter
HPA – Health Products Act
HPLC – High Pressure Liquid Chromatogrphy
HSA – Health Sciences Authority
HVAC – Heat, Ventilation, Air Conditioning
I Up ↑
ICH – International Council of Harmonization
IDE – Investigational Device Exemption
IFPMA – International Federation of Pharmaceutical Manufacturers Associations
IGPA – International Generic Pharmaceutical Association
IMDRF – International Medical Device Regulators Forum
IND – Investigational New Drug
IOM – Investigations Operations Manual
IP – Intellectual Property
IPC – In-Process Controls
IPEC – International Pharmaceutical Excipients Council
IQ – Installation Qualification
IRB – Institutional Review Board
ISO – International Standardisation Organisation
ISPE – International Society for Pharmaceutical Engineering
IVD – In Vitro Diagnostics
IVDD – In Vitro Diagnostics Directive
IVDR – In Vitro Diagnostics Regulation
L Up ↑
LAF – Laminar Air Flow
LIMS – Laboratory Information Management System
LMS – Learning Management System
LOD – Loss-on-drying, Limit of Detection
LOQ – Limit of Quantification
M Up ↑
MAH – Market Authorization Holder
MCA – Medicines Control Agency (UK)
MCB – MasterCell Bank
MDD – Medical Device Directive
MDR – Medical Device Regulation
MDR – Medical Device Reporting
MDSAP – Medical Device Single Audit Program
MHRA – Medicines and Healthcare products Regulatory Agency (UK)
MOU – Memorandum of Understanding
MPCR – Master Production and Control Record
MRA – Mutual Recognition Agreement
N Up ↑
NAFTA – North American Free Trade Agreement
NAI – No Action Indicated
NAPM – National Association of Pharmaceutical Manufacturers
NAS – National Academy of Sciences (USA)
NCE – New Chemical Entity
NDA – New Drug Application
NIR – Near-Infrared (spectroscopy)
NIST – National Institute of Science and Technology (USA)
NOR – Normal Operating Range
NPA – National Pharmaceutical Alliance
O Up ↑
OAI – Official Action Indicated
OC – Oral Contraceptive
OEM – Original Equipment Manufacturer
OOS – Out of Specification
OOT – Out of Trend
OQ – Operational Qualification
OTC – Over-the-counter
OTS – Off-the-shelf
P Up ↑
PA – Participating Authority
PAHO – Pan American Health Organization
PAI – Pre-Approval Inspection
PAR – Proven Acceptable Range
PAS – Prior Approval Supplement
PAT – Process Analytical Technology
PCR – Polymerase Chain Reaction
PET – Positron Emission Tomography
PDA – Parenteral Drug Association
PDUFA – Prescription Drug User Fee Act (USA, 1992)
PEFRAS – Pan European Federation of Regulatory Affairs Society
PERT – Program Evaluation and Review Technique
PhARMA – Pharmaceutical Association of Research-based Manufacturers (PMA, USA)
PIC – Pharmaceutical Inspection Convention (EFTA)
PIC/S – Pharmaceutical Inspection Cooperation Scheme
PID (P&ID) – Process (piping) and Instrumentation Diagrams (drawings)
PLC – Programmable Logic Controller
PM – Preventive Maintenance
PMA – Pre Market Approval
POM – Prescription-Only-Medicine
PPQ – Process Performance Qualification
PQ – Performance Qualification
PQ – Process Qualification
PQR – Product Quality Review
PQRI – Product Quality Research Institute
PRRC – Person Responsible for Regulatory Compliance
PTO – Patent and Trademark Office (USA)
PV – Process validation
PW – Purified Water
Q Up ↑
QA – Quality Assurance
QbD – Quality by Design
QC – Quality Control
QCU – Quality Control Unit
QMS – Quality Management System
QP – Qualified Person
QRM – Quality Risk Management
QSIT – Quality System Inspection Techniques
QS – Quality Systems
QSR – Quality System Record
QSReg – Quality System Regulation
R Up ↑
R&D – Research & Development
RA – Regulatory Affairs
RAs – Regulatory Authorities
RFID – Radiofrequency Identification
RO – Reverse Osmosis
RPM – Revolutions per Minute, varvtal
RSD – Relative Standard Deviation
S Up ↑
SAT – Site Acceptance Testing
SAL – Sterility Assurance Level
SD – Standard Deviation
SIP – Steaming In Place
SME – Subject Matter Expert
SMO – Site Management Organization
SNI – Standardized Numerical Identification
SOP – Standard Operating Procedure
SPC – Summary of Product Characteristics (EU, DMF per Mutual Recognition Procedure)
SPC – Statistical Process Control
SRM – Specified Risk Material (EU)
SS – Stainless Steel
SUD – Single Use Devices
T Up ↑
TC – Technical Committee
TC – Third Country
TOC – Total Organic Carbon
TPN – Total Parenteral Nutrition
TQM – Total Quality Management
TSE – Transmissible Spongiform Encephalopathies (Veure BSE)
U Up ↑
URS – User Requirement Specification
UPS – Uninterrupted Power Supply
USP-NF – United States Pharmacopoeia and the National Formulary
UV – Ultra Violet
V Up ↑
VAI – Voluntary action indication
VFA – Verband der Forschender Artzneitmittelherstellern
VMP – Validation Master Plan
VOC – Volatile Organic Compound
W Up ↑
WFI – Water For Injection
WG – Working Group
WHO – World Health Organization (OMS)
WL – Warning Letter
