List of Abbreviations

μS micro-Siemens, conductivity value (1S = 1/Ohm)
AANDA Abbreviated Antibiotic New Drug Application
ABPI Association of British Pharmaceutical Industries
ADE Acceptable Daily Exposure
AHU Air handling unit
AISI American Iron and Steel Institute
ANADA Abbreviated New Animal Drug Application
ANDA Abbreviated New Drug Application
ANOVA ANOVA Analysis of Variance
ANSI American National Standards Institute
AP Applicants Part of the Active Substance Master File
API Active Pharmaceutical Ingredient
API Analytical Profile Index (quick Bacterial Identification System)
APIC Active Pharmaceutical Ingredient Council
AQL Acceptable Quality Level / also: Acceptable Quality Limit
ASHRAE American Society of Heating, Refrigeration, and Air-Conditioning Engineers
ASME American Society of Mechanical Engineers
ASME-BPE American Society for Mechanical Engineers-Bioprocessing Equipment
ASMF Active Substance Master File
ASTM American Society for Testing and Materials
ATP Analytical Target Profil
ATCC American Type Culture Collection
ATMP Advanced Therapy Medicinal Product
BCF Bead and Channel Free = Butt-welding technology by GeorgFischer for plastic parts & pipes e.g. PVDF
BFS Blow/Fill/Seal
BIER Biological Indicator Evaluation Resistometer
BLA Biologic License Application
BMS Building Management System
BP British Pharmacopoeia
BPC Bulk Pharmaceutical Chemicals
BPE Bioprocessing Equipment
BPE Bulk Pharmaceutical Excipients
BR Batch Record
BSE Bovine Spongioform Encephalopathy
BSE Bovine Serum Albumin
CANDA Computer Assisted New Drug Application
CAPA Corrective Action Preventative Action
CAT Committee for Advanced Therapies
CBER Center for Biologics Evaluation and Research
CDER Center for Drug Evaluation and Research
cEDI continuous EDI
CEFIC European Chemical Industry Council
CEP (CoS) Certificate of Suitability of the EP
CFR Code of Federal Regulations (e.g. 21 CFR)
CFR 21 part 11 Code of Federal Regulations Title 21 part 11 Electronic records, electronic signatures
CFU Colony Forming Unit (bacteria count number)
cGMP current Good Manufacturing Practices
CIA Cross Impact Analysis
CIM Computer Integrated Manufacturing
CIP Cleaning In Place
CMC Chemistry, Manufacturing and Controls
CMS Change Management System
CMS Concerned Member State
COA Certificate of Analysis
COP Cleaning off place
COTS Commercial Off The Shelf
CpK Process Capability Index
CPMP Committee for Proprietary Medicinal Products
CPP Critica Process Parameter
CPU Central Processor Unit
CPV Continuous Process Verification (ICH Q 8, Annex 15)
CPV Continued Process Verification (FDA Process Validation Guidance, 2011)
CTMP Cell Therapy Medicinal Product
CQA Critical Quality Attribute
CS Clean Steam
CS Control Strategy
CSV Computer System Validation
CTD Common Technical Document
CTX Clinical Trial Excemption
CV Computer Validation
CVM Center for Veterinary Medicine
DAMOS Drug Application Methodology with Optical Storage
DCS Distribution Control System
DEHS Diethylhexylsebacat (test substance for HVAC-Qualification)
DfSS Design for Six Sigma
DHSS Department of Health and Human Services (UK)
DIN Deutsche Industrie Norm (German Industrial Standard)
DMF Drug Master File
DoE Design of Experiments
DOH Department of Health (UK)
DOP Dioctylphthalat
DP Drug Product
DQ Design Qualification
DS Design Specifications
DS Drug Substance
DTS double tube sheet (two plates on the head of a heat exchanger with air gap for leakages)
DVGW Deutscher Verein des Gas- und Wasserfaches (German Certification Organization for Gas & Water installations)
EBR Electronic Batch Record
EC European Community
ECA European Compliance Academy
EDI ElektroDeIonisation
EDMF European Drug Master File
EDQM European Directorate for the Quality of Medicines & Healtcare
EFPIA European Federation of Pharmaceutical Industries’ Associations
EFTA European Free Trade Area
EHEDG European Hygienic Equipment Design Group
EIR Establishment Inspection Report
ELA Establishment Licence Application
ELISA Enzym linked Immunosorbent Assay
EMA European Medicines Agency (new name for EMEA since 2009)
EMEA European Agency for the Evaluation of Medicinal Products (old name for EMA)
EMS Environment Monitoring System
EN European Norm = European Industrial Standard
EP European Pharmacopoeia
EPA Environmental Protection Agency
EPDM Ethylen-Propylen-Dien-(Monomer) - rubber
ERP Enterprise Resource Planning
ETO Ethylenoxid
EU Endotoxin Units (also IU = International Units = Infection Units)
EU European Union
Eucomed European Confederation of Medical Suppliers
F&F Fill and Finish
F(D)S Functional (Design) Specifications
FAT Factory Acceptance Test
FD&C Act (US) Food, Drug and Cosmetic Act
FDA Food and Drug Administration
FDAMA Food and Drug Administration Modernization Act
FDIS Final Draft International Standard
FDS Functional Design Specification
FFU Filter Fan Unit
FIFO First in, First out
FIP Fédération Internationale Pharmaceutique
FIR Failure Investigation Report
FIRA Federal Insecticide, Fungicide and Rotenticide Act
FMEA Failure Mode and Effects Analysis (System for Risk Analysis of a System)
FOI(A) Freedom of Information Act (FDA)
FR Federal Register
FS Feasibility Study
FTA Fault Tree Analysis
GAMP® Good Automated Manufacturing Practice (GAMP® is a trademark of ISPE -
GAP Good Analytical Practice
GC Gas Chromatography
GCLP Good Control Laboratory Practice
GCP Good Clinical Practice
GCVP Good Computer Validation Practices
GDP Good Distribution Practice
GEP Good Engineering Practice
GfI Guide for Inspection of
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
GSP Good Storage Practice
GTMP Cell Therapy Medicinal Product
GWP Good Warehousing Practice
HACCP Hazard Analysis and Critical Control Points (Risk Analysis)
HAT Hardware Acceptance Test
HAZOP Hazard Operability Analysis
HDS Hardware Design Specification
HEPA High Efficiency Particulate Air (Filter)
HHS Department of Health and Human Services
HIMA Health Industries Manufacturers Association
HMI Human Machine Interface
HPLC High Pressure (Performance) Liquid Chromatography
HPW Highly Purified Water (= Aqua Valde Purificata)
HSE Health, Safety and Environment
HVAC Heating, Ventilation and Air Conditioning
I/O input/output
ICH International Council for Harmonisation of Tech. Requirements for Pharmaceuticals for Human Use
IEC International Electrotechnical Commission
IEEE Institute of Electrical and Electronic Engineers, Inc.
IEST Institute of Environmental Sciences and Testing
IFPMA International Federation of Pharmaceutical Manufacturers Association
IMP Investigational Medicinal Product
INADA Investigational New Animal Drug Application
IND Investigational New Drug Application
INN International Non-proprietary Names
IPAC-RS International Pharmaceutical Aerosol Consortium on Regulation and Science
IPC In Process Control
IPEC International Pharmaceutical Excipients Council
IQ Installation Qualification
ISO International Standard Organization
ISPE International Society of Pharmaceutical Engineers
IU International Units (WHO-name since 2000 for Endotoxine Units = EU)
JP Japanese Pharmacopoeia
K Kurtosis
KPI Key Performance Indicator
LAF (LF) Laminar Airflow
LAL Limulus Amebocyte Lysate (Endotoxin-Test)
LD 50 Lethal Dose 50
LIMS Laboratory Information Management System
LOA Letter of Access (EU)
LOA Letter of Authorization (US)
LSL Lower Specificaton Limit
LVP Large Volume Parenterals
Lyo Lyophilisator
MA(H) Marketing Authorisation (Holder)
MAC Maximum Acceptable Carryover
MAL Material Air Lock
MBR Master Batch Record
MCB Master Cell Bank
MCL Maximum Contaminant Level
MDR Manufacturing Deviation Report
MES Manufacturing Execution System
MHLW Ministry of Health, Labour and Welfare (Japan)
MHRA Medicine and Healthcare Products Regulatory Agency
MIL Military Standardization Document
MMP Microbial Monitoring Programme
MMU 10E6 (US Million) International Units
MOU Memorandum of Understanding
MRA Mutual Recognition Agreement
MRP Mutual Recognition Procedere
MSA Measurement System Analysis
MSD Multi Stage Distillation
MSDS Material Safety Data Sheet
MVC Minimum Valid Concentration
MVD Maximum Valid Dilution
n.a. not applicable
NADA New Animal Drug Application
NBE New Biological Entity
NCE New Chemical Entity
NDA New Drug Application
NDE New Drug Entity
NDL No designated limit
NF National Formulary
NIH National Institute of Health (USA)
NIR Near Infrared spectroscopie
NIST National Institute of Standards and Technology, Washington, USA
NLT Not less than (time / analytical)
NME New Molecular Entities
NMR Nuclear Magnetic Resonance
NMT Not more than (as an analytical limit)
NOEL NO Observable Effect Level
NOR Normal Operating Range
OECD Organization for Economic Cooperation and Development
OMCL Official Medicines Control Laboratory
OOE Out of Expectation
OOL Out of Limits
OOS Out-of-Specification (test results)
OOT Out of Trend
OPV Ongoing Process Verification (Annex 15)
OQ Operation Qualification
OQ Operational Qualification
ORA Office of Regulatory Affairs (FDA)
ORO (US FDA’s) Office of Regional Operations
OTC Over-the-Counter (medications)
PAI Pre-Approval-Inspection
PAL Personnel Air Lock
PAR Proven Acceptable Ranges
PAT Process Analytical Technology
PBR Production Batch Record
PC Personal Computer
PC-Agar Plate Count Agar
PCR Polymerase Chain Reaction
PCS Process Control System
PDA Parenteral Drug Association (USA)
PDE Permitted Daily Exposure
PES Peressigsäure
Ph.Eur. European Pharmacopeaia
PhD Doctor of Philosophy
PhRMA Pharmceutical Research and Manufacturer Associations (USA)
PIC Pharmaceutical Inspection Convention
PIC/S Pharmaceutical Inspection Cooperation Scheme
PID or P&ID Pipe and Instrumentation Drawing or Piping & Installation Diagram
PID or P&ID Piping and Installation Drawing
PKI Public Key Infrastructure
PL Product Licence
PLA Product Licence Application
PLC Programmable Logic Controller
PMA Pharmaceutical Manufacturers Association
PMAC Pharmaceutical Manaufacturer’s Association of Canada
PMDA Pharmaceuticals and Medical Devices Agency (Japan)
PMF Plant Master File
PMS Post Marketing Surveillance
PoU Point of Use
ppb parts per billion
PPE Personal Protection Equipment
PPQ Process Performance Qualification
PQ Performance Qualification (Annex 15, PIC/S PI 006)
PQ Process Qualification (FDA Process Validation Guidance, 2011)
PQR Product Quality Review
PQRI Product Quality Research Institute
PS Pure Steam
PSF Product Specification File
PSG PS-Generator
PTFE Poly-Tetra-Fluor-Ethyleen (vulgo „Teflon“)
PV Process Validation
PVDF Polyvinylidenfluorid
PW Purified Water (= Aqua Purificata)
QA Quality Assurance
QAU Quality Assurance Unit
QbD Quality by Design
QC Quality Control
QCU Quality Control Unit
QFD Quality Function Deployment
QHD Qualified Hygienic Design
QM Quality Management
QMS Quality Management-System
QOS Quality Overall Summary of the Active Substance Master File
QP Qualified Person
QRM Quality Risk Management (ICH Q9)
QTPP Quality Target Product Profile
R&R-Analysis Repeatability & Reproducibility Analysis
R+D Research and Development
RA Risk Analysis
RAS Rapid Alert System
RABS Restricted Access Barrier System
RCS Reuter Centrifugal Sampler
RH Relative Humidity
RMS Reference Member State
RO Reverse Osmosis
RODAC Replicate Organism Detection and Counting
RP Restricted Part of the Active Substance Master File
rpm revolutions per minute
RTR Real Time Release
RTRT Real Time Release Testing
SAL Sterility Assurance Level
SAT Site Acceptance Test
SCADA Supervisory, Control and Data Acquisition
SCS Swiss Calibration Service
SDI Silt Density Index (= Membrane Blocking Index, typically measured over 15min = then SDI15)
SDS Software Design Specification
SIP Sterilisation (Steaming) in Place
SK Skewness
SLA Service Level Agreement
SMF Site Master File
SOP Standard Operation Procedure
SPC Statistical Process-Control
SPC Summary of Product Characteristics
SS Stainless Steel
SUPAC Scale Up and Post Approval Changes
SVP Small Volume Parenterals
TAMC total (viable) aerobic microbial count
tbd to be defined
TEP Tissue Engineered Product
TH Technische Hochschule (Technical University)
TLC Thin Layer Chromatograpghy
TOC Total Organic Carbon
TPV Traditional Process Validation
TQM Total Quality Management
TSCA Toxic Substances Control Act
TYMC Total combined (viable) yeast/moulds count (KBE/ml-Test)
UCL Upper confidence limit (for particle statistics)
UF Ultrafiltration
ULPA Ultra Low Penetrating Filter
URS User Requirement Specification
USL Upper Specification Limit
USP United States Pharmacopoeia
VDMA Verband Deutscher Maschinen- und Anlagenbau (Society of German Machine and Plant Construction)
VHP Vaporized Hydrogen Peroxide (H2O2-gas for sanitisation clean rooms)
VMP Validation Master Plan
VPN Virtual Private Network
WCB Working Cell Bank
WCF Water conversion factor (ratio out to in qty water)
WFI Water for Injection
WHO World Health Organization
WIP Washing In Place