0.B Abkürzungen
AL37
A
AA
Arbeitsanweisung
AAAS
American Association for the Advancement of Science
AAPS
American Association of Pharmaceutical Scientists
ABAP
Advanced Business Application Program
ABDA
Bundesvereinigung Deutscher Apothekerverbände
ABPI
Association of the British Pharmaceutical Industry
ACOS
Advisory Committee on Safety
ACPH
Air Changes Per Hour
ACS
American Chemical Society
ADE
Adverse Drug Experience
ADI
Acceptable Daily Intake
ADME
Absorption, Distribution, Metabolism and Excretion
ADR
Adverse Drug Reaction
AE
Adverse Effects (Event, Experience)
AESGP
Association Européenne des Spécialités Pharmaceutiques Grand Public (EU)
AFAQ
Association Francaise pour l´Assurance de la Qualité
AFD
Anticipatory Failure Determination
AFI
Arbeitsgemeinschaft Fachinformation
AFNOR
Association Francaise de Normalisation
AG AATB
Arbeitsgruppe für Arzneimittel-, Apotheken-, Transfusions- und Betäubungsmittelwesen der AOLG
AG TAM
Arbeitsgruppe Tierarzneimittel der LAV
AG TT
Arbeitsgruppe Tierseuchen, Tiergesundheit der LAV
AGVU
Arbeitsgemeinschaft Verpackung und Umwelt
AIBS
American Institute of Biological Science
AiF
Arbeitsgemeinschaft industrieller Forschungsvereinigungen
AIM
Active Ingredient Manufacturer
AIM
Aide-Mémoire
AIP
Application Integrity Policy
AIP
Abbreviated Inspection Program
AISI
American Iron and Steel Institute
ALARA
As Low As Reasonably Achievable
ALU
Arithmetic Logic Unit
AMA
American Medical Association
AMC
Airborne Molecular Contamination (gemäß SEMI)
AMD
Analytical Method Development
AMG
Arzneimittelgesetz
AM-HandelsV
Arzneimittelhandelsverordnung - Verordnung über den Großhandel und die Arzneimittelvermittlung
AMGVwV
Allgemeine Verwaltungsvorschrift zur Durchführung des Arzneimittelgesetzes
AMIS
Arzneimittelinformationssystem (Datenbank des DIMDI)
AMIS BL
Datenbankgestütztes Informationssystem über Arzneimittel für die Behörden der Bundesländer
AMK
Arzneimittelkommission der Deutschen Apotheker
AMPAC
Analytical Methods Post-Approval Changes
AMQ
Analytical Method Qualification
AMRadV
Verordnung über radioaktive oder mit ionisierenden Strahlen behandelte Arzneimittel
AMUST
Arzneimitteluntersuchungsstelle
AMÜSt
Arzneimittelüberwachungsstelle
AMV
Analytical Method Validation
AMWHV
Arzneimittel- und Wirkstoffherstellungsverordnung
ANADA
Abbreviated New Animal Drug Application
ANDA
Abbreviated New Drug Application
ANOVA
Analysis of Variance
ANSES
Agence nationale de sécurité sanitaire de l‘alimentation, de l‘environment et du travail
ANSI
American National Standards Institute
ANSM
Agence nationale de sécurité du médicament et des produits de santé
ANVISA
Agência Nacional de Vigilância Sanitária (Brasil)
AOAC
Association of Official Analytical Chemists
AOLG
Arbeitsgemeinschaft der Obersten Landesgesundheitsbehörden
AOQ
Average Outgoing Quality
AP
American Patent
APA
Aseptical Processing Area
APEC
Asian-Pacific Economic Cooperation
APGI
Association de Pharmacie Galénique Industrielle (F)
AphA
American Pharmaceutical Association
API
Active Pharmaceutical Ingredient
APIC
Active Pharmaceutical Ingredients Committee
APISM
API-Starting Material
ApoBetrO
Apothekenbetriebsordnung
APQP
Advanced Product Quality Planning
APR
Annual Product Review
APSTJ
Academy of Pharmaceutical Sciences and Technology, Japan
APV
Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e.V.
AQL
Acceptable Quality Level
AR
Annual Report
ASA
American Statistical Association
ASAP
Administrative Systems Automation Project
ASCII
American Standard Code for Information Interchange
ASEAN
Association of South-East Asian Nations
ASHRAE
American Society of Heating, Refrigerating and Air-Conditioning Engineers
ASME
American Society of Mechanical Engineers
ASMF
Active Substance Master File
ASQ
American Society for Quality
ASQ
Deutsche Arbeitsgemeinschaft für Statistische Qualitätskontrolle
ASQC
American Society for Quality Control
ASTM
American Society for Testing and Materials
ATCC
American Type Culture Collection
ATMP
Advanced Therapy Medicinal Products
ATP
Accord relatifs aux transports internationaux de denrées périssables et aux engins spéciaux à utiliser pour ces transports
AUC
Area under the Curve
B
BACPAC
Bulk Actives Post-Approval Changes (FDA)
BAH
Bundesfachverband der Arzneimittel-Hersteller e.V.
BAM
Bundesanstalt für Materialprüfung
BAN
British Approved Names
BAPI
Biological Active Pharmaceutical Ingredient
BARQA
British Association of Research Quality Assurance
BAT
Best Available Techniques
BBA
Biologische Bundesanstalt
BCC
Blind Carbon Copy
BCT
Bacterial Challenge Test
BDCS
Biopharmaceutic Drug Classification System
BDE
Betriebsdatenerfassung
BfArM
Bundesinstitut für Arzneimittel und Medizinprodukte im Geschäftsbereich des Bundesministeriums für Gesundheit
BfR
Bundesinstitut für Ernährung und Landwirtschaft
BFS
Blow-Fill-Seal
BI
Biologocial Indicator
BIO
Biotechnology Industry Organization (US)
BIPM
Bureau International des Poids et Mesures
BIRA
British Institute of Regulatory Affairs
BLA
Biologics Licence Application (FDA)
BMEL
Bundesministerium für Ernährung und Landwirtschaft
BMELV
Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz
BMF
Biologics Master File
BNF
British National Formulary
BOB
Bundesoberbehörde
BP
British Pharmacopoeia (auch BPh)
BPC
British Pharmaceutical Codex
BPC
Bulk Pharmaceutical Chemical
BPCC
Bulk Pharmaceutical Chemicals Committee
BPE
Bulk Pharmaceutical Excipients
BPE
Business Process Excellence
BPF
Bonnes Pratiques de Fabrication
BPh
British Pharmacopoeia (auch BP)
BPI
Bundesverband der Pharmazeutischen Industrie e.V.
BQF
British Quality Foundation
BR
Batch Record
BRR
Batch Record Review
BSC
Balanced Scorecard
BSC
Biological Safety Cabinet
BSI
British Standards Institute
BSI
Bundesamt für Sicherheit der Informationstechnik
BSL
Biological-Safety-Level
BUA
Beratergremium für umweltrelevante Altstoffe
BUWG
Blend Uniformity Working Group (FDA)
BVE
Bundesvereinigung der Deutschen Ernährungsindustrie
BVL
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
BVMed
Bundesverband Medizintechnologie e. V.
BWP
Biotechnology Working Party
C
CAB
Conformity Assessment Body
CAD
Computer-Aided Design
CADREAC
Collaboration Agreement between Drug Regulatory Authorities of European Union Associated Countries
CAE
Computer-Aided Engineering
CAI
Compounding Aseptic Isolator
CAM
Computer-Aided Manufacturing
CANDA
Computer-Assisted New Drug Application
CAO
Computer-Aided Office Automation
CAP
Computer-Aided Planning
CAP
Centrally Authorised Product
CAPA
Corrective Action and Preventive Action
CAPLA
Computer-Assisted Product Licence Application
CAPRA
Canadian Association of Pharmaceutical Regulatory Affairs
CAQ
Computer-Aided Quality
CAS
Chemical Abstracts Service
CAS
Change Approval System
CAT
Critical Assessment Team
CATT
Computer-Aided Test Tool
CBER
Center for Biologics Evaluation and Research
CBT
Computer-Based Training
CD
Committee Draft (ISO)
CDC
Center for Disease Control (US)
CDER
Center for Drug Evaluation and Research
CDM
Clinical Data Management
CDP
Clinical Development Plan
CDRH
Center for Devices and Radiological Health
CDSCO
Central Drugs Standard Control Organization (India)
CE
Commission Européenne
CEC
Commission of the European Communities (EC)
CEFIC
European Chemical Industries Council
CEN
Comité Européen de Normalisation (Europäisches Komitee für Normung)
CENELEC
Comité Européen de Normalisation Électrotechnique
CEO
Chief Executive Officer
CEP
Certification of Suitability of European Pharmacopeia Monographs
CETA
Controlled Environment Testing Association
CF
Compliance-Faktor
CFDA
Chinese Food and Drug Administration
CFR
Code of Federal Regulations (US)
CFSAN
Center for Food Safety and Applied Nutrition (FDA)
CFU
Colony Forming Units
CFU
Control Functional Unit
cGMP
current Good Manufacturing Practice
cGMPR
current Good Manufacturing Practice Regulation
CHMP
Committee for Medicinal Products for Human Use
CIA
Chemical Industries Association Ltd (UK)
CID
CTFA Cosmetic Ingredient Dictionary
CIM
Computer Integrated Manufacturing
CIP
Cleaning-in-Place
CIP
Continuous Improvement Process
CIPM
Comité International des Poids et Mesures
CIR
Cosmetic Ingredient Review
CISA
Committee on International Scientific Affairs (US)
CISQ
Certificazione Italiana dei Sitemi Qualita delle Aziende
CMC
Chemistry, Manufacturing and Controls (FDA)
CMCCC
CMC Coordinating Committee (CDER)
CML
Calibration Master List
CMO
Contract Manufacturing Organization
CMS
Change Management System
CMS
Content Management System
CNC
Computerized Numerical Control
COA
Certificate of Analysis
Cod Franc
Codex Français
COE
Code of Ethics
COMIS
Centerwide Oracle-based Management Information System (FDA)
COP
Cleaning-out-of-Place
COTS
Computer-off-the-Shelf
COTS
Commercial off-the-shelf
CPACT
Center for Process Analytics and Control Technology
CPD
Chemical Pharmaceutical Documentation
CPGM
Compliance Program Guidance Manual (FDA)
CpK
Process Capability-Konstante
CPMP
Committee for Proprietary Medicinal Products (EMA)
CPP
Certificate of Pharmaceutical Product
CPSC
Consumer Product Safety Commission (US)
CPU
Central Processing Unit
CQA
Critical Quality Attribute
CRA
Clinical Research Associate
CRADA
Cooperative Research and Development Agreement (with NIH)
CRC
Child Resistant Closure
CRF
Case Report Form
CRM
Clinical Research Monitor
CRM
Customer Relationship Management
CRO
Contract Research Organization
CRO
Clinical Research Organisation
CRS
Controlled Release Society (US)
CS
Clean Steam
CS
Computergestütztes System
CSA
Canadian Standards Association
CSDD
Center for the Study of Drug Development
CSO
Consumer Safety Officer (FDA)
CSP
Compounded Sterile Preparation
CSV
Computer System Validation
CSVC
Computer System Validation Committee (PhRMA)
CTA
Clinical Trial Application
CTD
Common Technical Document
CTFA
The Cosmetic, Toiletry and Fragrance Association
CTX
Clinical Trial Exemption
CoCP
Compilation of Community Procedures on Inspections and Exchange of Information
CPV
Continous Process Verification
CUA
Chemisches Untersuchungsamt
CV
Computer Validation
CVM
Center of Veterinary Medicine (FDA)
CVMP
Committee for Veterinary Medicinal Products (EC)
CWQC
Company-Wide Quality Control
CxMP
Ausschuss für Humanarzneimittel oder Ausschuss für Tierarzneimittel (EMA)
D
DAB
Deutsches Arzneibuch
DAC
Deutscher Arzneimittel Codex
DAkkS
Deutsche Akkreditierungsstelle
DAMA
Deutsche Arzneimittelagentur
DAS
Deutsche Auslegeschrift
DAV
Deutscher Apotheker Verlag
DBP
Deutsches Bundespatent
DCS
Distributed Control Systems
DDMAC
Division of Drug Marketing, Advertising and Communications (FDA)
DEMOC
Determining and Managing of Conditions
DFÜ
Datenfernübertragung
DGHM
Deutsche Gesellschaft für Hygiene und Mikrobiologie
DGQ
Deutsche Gesellschaft für Qualität
DGRA
Deutsche Gesellschaft für Regulatorische Angelegenheiten
DHHS
Department of Health and Human Services (US)
DHSS
Department of Health and Social Security
DIA
Drug Information Association
DIMDI
Deutsches Institut für Medizinische Dokumentation und Information
DIN
Deutsches Institut für Normung
DIP
Drying in Place
DIS
Draft International Standard (ISO)
DIW
Deionisiertes Wasser
DKD
Deutscher Kalibrierdienst
DMAIC
Define Measure Analyze Improve Control
DMF
Drug Master File
DMPQ
Division of Manufacturing and Product Quality (FDA)
DMS
Dokumentenmanagementsystem
DOC
Dissolved Organic Carbon
DOE
Design of Experiments
DOS
Deutsche Offenlegungsschrift
DP
Deutsches (DDR) Patent
DPhG
Deutsche Pharmazeutische Gesellschaft
DQ
Design Qualification
DQS
Deutsche Gesellschaft zur Zertifizierung von Qualitätsmanagementsystemen
DRA
Drug Regulatory Authorities
DRF
Darreichungsform
DS
Drug Substance
DS
Design Specification
DSI
Division of Scientific Investigation (FDA)
DSMZ
Deutsche Sammlung von Mikroorganismen und Zellkulturen
DSNP
Development of Standardized Nomenclature Project (FDA)
DTC
Direct to Consumer
DTD
Document Type Definition
DV
Datenverarbeitung
DVG
Deutsche Veterinärmedizinische Gesellschaft
DVGW
Deutscher Verein des Gas- und Wasserfaches e.V.
DVS
Dokumentenverwaltungssystem
DVV
Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e.V.
E
EA
Environmental Assessment
EA
European Cooperation for Accreditation
EAL
European Cooperation for Accreditation of Laboratories
EAPB
European Association of Pharma Biotechnology
EBR
Electronic Batch Record
EBRS
Electronic Batch Recording System
EBSA
European Biosafety Association
EC
European Commission
EC
European Communities
ECA
European Compliance Academy
ECCC
European Community Chemistry Committee (EC)
ECCLS
European Committee for Clinical Laboratory Standards
ECETOC
European Centre for Ecotoxicology and Toxicology of Chemicals
ECL
Exposure Control Limit
ECPHIN
European Community Pharmaceutical Products Information Network
EDI
Electronic Data Interchange
EDI
Elektrodeionisation
EDM
Engineering Data Management
EDMF
European Drug Master File
EDMS
Eletronic Data Management System
EDQM
European Directorate for the Quality of Medicines and HealthCare
EEA
European Economic Association
EEC
European Economic Community (EC)
EFA
European Food Authority
EFCG
European Fine Chemical Group
EFG
Expertenfachgruppe
EFPIA
European Federation of Pharmaceutical Industries and Associations
EFQM
European Foundation for Quality Management
EFTA
European Free Trade Area
EGA
European Generic Medicines Association
EHC
Environmental Health Criteria
EHEDG
European Hygienic Equipment Design Group
EHPM
European Federation of Health Product Manufacturers‘ Association
EINECS
European Inventory of Existing Chemical Substances
EIR
Establishment Inspection Report (FDA)
EKK
Ethikkommission
ELA
Establishment License Application (FDA)
ELV
Exposure Limit Value
EMA
Europäische Arzneimittel-Agentur
EMAS
European Eco Management and Audit Scheme
EMR
Elektronische Mess- und Regeltechnik
EMS
Enviromental Management System
EN
Europäische Norm
EOL
Exchange of Letters (FDA)
EOQ
European Organization for Quality
EOTC
European Organization for Testing and Certification
EP
European Parliament
EP
European Pharmacopoeia
EPA
Environmental Protection Agency (US)
EPAR
European Public Assessment Report
EPK
Ereignisgesteuerte Prozesskette
EPROM
Erasable Programmable Read-Only Memory
EQA
European Quality Award
EQS
Environmental Quality Standards
ER
Electronic Record
ERES
Electronic Records, Electronic Signature
ErgB
Ergänzungsbuch zum Deutschen Arzneibuch
ERP
Enterprise Resource Planning
ES
Electronic Signature
ESCOP
European Scientific Cooperative for Phytotherapy
ESRA
European Society of Regulatory Affairs
ESTRI
Electronic Standards for Transmission of Regulatory Information
ETA
Event Tree Analysis
EU
European Union
EuAB
Europäisches Arzneibuch
EUCOMED
European Confederation of Medical Device Manufacturers Associations
EudraGMDP
Community database on manufacturing, import and wholesale-distribution authorisations, and good manufacturing-practice (GMP) and good-distribution-practice (GDP) certificates
EUFEPS
European Federation for Pharmaceutical Sciences
EUGMP
European Union Good Manufacturing Practice
EUROPAMA
European Packaging Machinery Manufacturers Association
EWG
Expert Working Group (ICH)
EWP
Efficacy working party
F
FA
Funktionsanalyse
FAO
Food and Agriculture Organization (UN)
FAQ
Frequently Asked Questions
FAT
Factory Acceptance Test
FBD
Funktionsblockdiagramm
FCA
Field Corrective Action
FCC
Food and Chemical Codex
FCCSET
Federal Coordinating Council for Science, Engineering and Technology
FCI
Food and Chemical Index
FCIO
Fachverband der chemischen Industrie Österreich
FD&C Act
Food, Drug and Cosmetic Act (US)
FDA
Food and Drug Administration (US)
FDIS
Final Draft International Standard (ISO)
FDS
Functional Design Specification
FEFO
First Expired-First Out
FEM
Fédération Européenne de la Manutention
FFDCA
Federal Food, Drug and Cosmetic Act (FDA)
FI
Failure Investigation
FIC
Fédération des Industries Chimiques de Belgique
FICI
Federation of Irish Chemical Industries
FIFO
First In-First Out
FIP
Fédération Internationale Pharmaceutique
FIR
Forschungsinstitut für Rationalisierung e.V.
FIR
Failure Investigation Report
FMEA
Failure Mode and Effect Analysis
FMECA
Failure Mode Effects and Criticality Analysis
FOI
Freedom of Information
FOIA
Freedom of Information Act (US)
FPAP
First Party Audit Program (FDA)
FPMAJ
Federation of Pharmaceutical Manufacturers‘ Association of Japan
FPV
Fertigpackungsverordnung
FPVO
Füll- und Pack-Verordnung
FR
Federal Register
FS
Functional Specification
FS
Feasibility Study
FTA
Fault Tree Analysis
FTC
Federal Trade Commission (US)
FU
Farmacopea Ufficiale della Republica Italiana
G
GACP
Good Agriculturing and Collection Practice
GALP
Good Automated Laboratory Practices (EPA)
GAMP
Good Automated Manufacturing Practice (ISPE)
GAP-ML
Gute Analytische Praxis im Medizinischen Laboratorium
GATT
General Agreement on Tariffs and Trade
GCLP
Good Control Laboratory Practice
GCP
Good Clinical Practice
GCS
Good Common Sense
GCVP
Good Computer Validation Practice
GDP
Good Distribution Practice
GEP
Good Engineering Practice
GERM
Good Electronic Records Management
GFP
Gute Fachliche Praxis
GGP
Good Guidance Practice (FDA)
GLP
Good Laboratory Practice
GMA
Gesellschaft für Mess- und Automatisierungstechnik (VDI/VDE)
GMK
Gesundheitsministerkonferenz
GMO
Genetically Modified Organisms
GMP
Good Manufacturing Practice
GPG
Good Practice Guide
GPHF
German Pharma Health Fund
GPIA
Generic Pharmaceutical Industry Association (US)
GRAS
Generally Recognized as Safe
GRASE
Generally Recognized as Safe and Effective
GRP
Good Review Practice
GSIA
Gesellschaft der Schweizerischen Industrie-Apotheker(innen)
GSP
Good Storage Practice
GSP
Good Scientific Practice
GTDP
Good Trade and Distribution Practice
GTP
Good Transportation Practice
GUM
Guide to the Expression of Uncertainty in Measurement
GVM
Gesellschaft für Verpackungsmarktforschung
GVO
Gentechnisch veränderter Organismus
GWQAP
Government-Wide Quality Assurance Program
GxP
Good „x“ Practice, wobei „x“ stehen kann für Clinical, Distribution,
Engineering, Guidance, Laboratory, Manufacturing, Review, Scientific,
Storage, Transportation
H
HA
Herstellungsanweisung
HACCP
Hazard Analysis Critical Control Point
HAT
Hardware Acceptance Testing
HAZOP
Hazard and Operability
HCFA
Health Care Financing Administration (US)
HDGMP
Human Drug GMP Notes (FDA)
HDS
Hardware Design Specification
HEPA-Filter
High Efficency Particulate Air Filter
HIMA
Health Industry Manufacturers Association
HLK
Heizung, Lüftung und Klima(tisierung) (auch HVAC)
HMA-WGEO
Heads of Medicines Agencies - Working Group of Envorcement Officers
HPAPI
Highly Potent Active Pharmaceutical Ingredient
HPB
Health Protection Bureau (Canada)
HPRA
Health Products Regulatory Authority
HPW
Highly Purified Water
HTML
Hypertext Markup Language
HTS
High-Throughput Screening
HUB
Hauptumschlagsplatz
HV
Herstellungsvorschrift
HVAC
Heating, Ventilation and Air-Conditioning
HWG
Heilmittelwerbegesetz (Schweiz)
I
IAAR
Independent Association of Accredited Registrars (US)
IAMS
Instrument Asset Management Team
IAQ
International Academy for Quality
IASG
International Automotive Sector Group
IB
Investigator‘s Brochure
IC
Informed Consent
IC
Integrated Circuit
ICC
International Chamber of Commerce
ICDRA
International Conference of Drug Regulatory Authorities
ICH
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
ICSC
International Chemical Safety Cards
IDE
Investigational Device Exemption (FDA)
IEC
International Electrotechnical Commission
IEEE
Institute for Electrical and Electronics Engineers
IFPMA
International Federation of Pharmaceutical Manufacturers Association
IGPA
International Generic Pharmaceutical Alliance
IGR
Interessengemeinschaft Regelwerke Technik
IIT
Investigator Initiated Trials
IKS
Interkantonale Kontrollstelle (für Heilmittel) (Schweiz)
IKW
Industrieverband Körperpflege- und Waschmittel
ILAC
International Laboratory Accreditation Cooperation
IMP
Investigational Medicinal Product
IMPD
Investigational Medicinal Product Dossier
IMS
Integriertes Managementsystem
INA
Information Not Available
IND
Investigational New Drug
INDA
Investigational New Drug Application (FDA)
INDC
Investigational New Drug Committee (FDA)
INN
International Nonproprietary Names
IOM
Inspections Operations Manual
IP
Intellectual Property
IPC
In-Process-Control
IPCS
International Programme on Chemical Safety
IPEC
International Pharmaceutical Excipients Council
IPK
Inprozesskontrolle
IPRD
International Product Registration Document
IPRO
Independent Pharmaceutical Research Organization
IPS
Instandhaltungsplanung und -steuerung
IQ
Installation Qualification
IQA
International Quality Assurance
IRB
Institutional Review Board (FDA)
IRD
International Registration Document
IRIS
Integrated Risk Information System
IRS
Identical, Related or Similar
ISA
Instrumentation, Systems and Automation Society
ISE
Integrated Summaries of Efficacy
ISDN
Integrated Services Digital Network
ISO
International Organization for Standardization
ISPE
International Society for Pharmaceutical Engineering
ISSS
Information Society Standardization System
IT
Information Technology
ITCC
Information Technology Coordinating Committee (CDER)
ITIL
Information Technology Infrastructure Library
IVD
In Vitro Diagnostics
IVF
In-vitro-Fertilisation
IVIVC
In Vitro In Vivo Correlation
IV(R)S
Interactive Voice (Response) System
IWG
Inspectors Working Group
IW(R)S
Interactive Web (Response) System
J
JAN
Japanese Accepted Names
JAP
Joint Audit Programme
JCGM
Joint Committee for Guides in Metrology
JETT
Joint Equipment Transition Team
JIT
Just in Time
JNIH
Japanese National Institute of Health
JP
Japanese Pharmacopoeia
JPMA
Japan Pharmaceutical Manufacturers Association
JSG
Joint Sectoral Group
JUSE
Japanese Union of Scientists and Engineers
K
KBE
Koloniebildende Einheit
KOF
Körperoberfläche
KPI
Key Performance Indicator
KVP
Kontinuierlicher Verbesserungsprozess
L
 
LAFW
Laminar Airflow Workbench
LAL-Test
Limulus-Amöbocyten-Lysat-Test
LAN
Local Area Network
LÄP
Leitende ärztliche Person
LAV
Länderarbeitsgemeinschaft Verbraucherschutz
LF
Laminar Flow
LH
Leiter der Herstellung
LFBG
Lebensmittel-, Futtermittel- und Bedarfgegenstände-Gesetz
LIMS
Laboratory Information Management System
LIR
Laboratory Investigation Report
LKP
Leiter der klinischen Prüfung
LMBG
Lebensmittel- und Bedarfsgegenständegesetz
LOC
Level of Concern
LOD
Limit of Detection (Nachweisgrenze)
LOEL
Lowest-Observerd Effect Level
LOQ
Limit of Quantitation
LQ
Leiter der Qualitätskontrolle
LRV
Logarithmic Reduction Value
LSP
Logistics Service Provider
LVP
Large Volume Parenteral
LW
Luftwechsel
LZA
Luftzerlegungsanlage
M
MA
Marketing Authorization
MAA
Marketing Authorization Application
MACO
Maximum Acceptable Carry-Over
MAH
Marketing Authorisation Holder
MAIL
Medicines Act Information Letter
MAL
Medicines Act Leaflets
MaPPs
Manual of Policies and Procedures (FDA)
MBC
Minimum Bactericidal Concentration
MBO
Management by Objectives
MBR
Master Batch Record
MCB
Master Cell Bank
MDD
Medical Device Directives (EU)
MDE
Maschinendatenerfassung
MDR
Medical Device Report
Med DRA
Medical Dictionary for Regulatory Activities
MEP
Member of the European Parliament
MES
Manufacturing Execution System
MF
Microfiltration or Microfilter
MHLW
Ministry of Health, Labour and Welfare (Japan)
MHRA
Medicines and Healthcare products Regulatory Agency
MIC
Minimum Inhibitory Concentration
MJA
Mutual Joint Audit (EU)
MJV
Mutual Joint Visit (EU)
MMP
Microbiological Monitoring Programme
MOA
Memoranda of Agreement (FDA)
MOC
Memoranda of Cooperation (FDA)
MOH
Ministry of Health
MOU
Memoranda of Unterstanding (FDA)
MPA
Medical Product Agency (Schweden)
MPG
Medizinproduktegesetz
MPI
Master Production Instruction
MPK
Medizinprodukte-Klassifizierung
MRA
Mutual Recognition Agreement
MRFG
Mutual Recognition Facilitation Group
MSC
Manufacturing Scorecard
MSDS
Material Safety Data Sheet
MSL
Master Seed Lot
MSR
Messen, Steuern, Regeln
MSSO
Management Support and Services Organization (ICH)
MTB
Master Transgenic Bank
MTBF
Mean Time Between Failure
MTD
Maximum Tolerated Dose
MTMG
Menschlich, tierisch, mikrobiell oder gentechnisch hergestellter Wirkstoff
MTTF
Mean Time to Failure
MVP
Master-Validierungs-Plan
MVS
Master Virus Seed
N
NACCB
National Accreditation Council for Certification Bodies
NADA
New Animal Drug Application
NAI
No Action Indicated (FDA)
NAMAS
National Measurement Accreditation Service
NAMUR
Normen-Arbeitsgemeinschaft für Mess- und Regeltechnik in der Chemischen Industrie
NAPM
National Association of Pharmaceutical Manufacturers (US)
NAS
New Active Substance
NATRIC
National Reporting and Investigation Centre
NBE
New Biological Entity
NBS
National Bureau of Standards
NCE
New Chemical Entity
NCTC
National Collection of Type Cultures (UK)
NDA
New Drug Application
NDE
New Drug Evaluation (FDA)
NDMA
Nonprescription Drug Manufacturers Association
NDS
New Drug Study
NEL
No Effect Level
NF
National Formulary
NF
Nanofiltration or Nanofilter
NFG
Note for Guidance (CPMP)
NHS
National Health Service
NHW
National Health and Welfare Department (Canada)
NIBSC
National Institute for Biological Standards and Control (UK)
NIH
National Institute of Health
NIOSH
National Institute for Occupational Safety and Health (US)
NIST
National Institute for Standards and Technology (US)
NME
New Molecular Entity
NND
New and Non-official Drugs
NNR
New and Non-official Remedies
NOEL
No-Observed-Effect Level
NPA
National Pharmaceutical Alliance (US)
NQSZ
Normenausschuss Qualitätsmanagement, Statistik und Zertifizierungsgrundlagen
NRC
National Research Council (US)
NSF
National Sanitation Foundation (US)
NSR
Non-significant Risk
NTIS
National Technical Information Service (US)
O
ÖAB
Österreichisches Arzneibuch
OAI
Official Action Indicated
ODE
Office of Drug Evaluation (FDA)
OECD
Organization for Economic Cooperation and Development
OEE
Overall Equipment Efficiency
OEG
Obere Eingriffsgrenze
OEL
Occupational Exposure Limit
OEM
Original Equipment Manufacturer
OIML
Organisation Internationale de Métrologie Légale
OLB
Oberste Landesbehörde
OLE
Object Linking and Embedding
OLGB
Oberste Landesgesundheitsbehörden
OMCL
Official Medicinal Control Laboratories
OMO
Office of Management and Operations (FDA)
ONDC
Office of New Drug Chemistry (CDER)
ONDQA
Office of New Drug Quality Assessment (FDA)
OOS
Out of Specification
OPC
OLE for Process Control
OPCD
Optimized Preclinical Development
OPEX
Operative Exzellenz
ÖPhG
Österreichische Pharmazeutische Gesellschaft
OPS
Office of Pharmaceutical Science (CDER)
OQ
Operational Qualification
ORA
Office of Regulatory Affairs (FDA)
OS
Operating System
OSAT
On-Site Acceptance Test
OSHA
Occupational Safety and Health Administration (US)
OSHA
On-Site Hazard Analysis
OTC
Over-the-Counter
OTG
Obere Toleranzgrenze
OWG
Obere Warngrenze
OWiG
Ordnungswidrigkeitengesetz
P
P & ID
Piping and Instrument Diagram
PA
Pre-Approval (FDA)
PA
Prüfungsanweisung
PAA
Premarket Approval Application
PAB
Pharmaceutical Affairs Bureau
PAC-ATLS
Post-Approval Changes Analytical Testing Laboratory Sites (FDA)
PACPAC
Packaging Post Approval Changes (FDA)
PAC-SAS
Post-Approval Changes for Sterile Aqueous Solutions (FDA)
PAD
Pharmacological Active Dose
PAI
Pre-Approval Inspection
PAITS
Pre-Approval Inspection Tracking System (FDA)
PAR
Proven Acceptable Range, Prozessvalidierung
PAS
Prior Approval Supplement (SUPAC)
PAT
Preliminary Acceptance Test
PAT
Process Analytical Technology (FDA)
PBR
Production Batch Record
PC
Programming Committee (ISO)
PCA
Principal Component Analysis
PCIDs
Physical-chemical-identifiers
PCS
Process Control System
PDA
Parenteral Drug Association (US)
PDE
Permitted Daily Exposure
PDF
Portable Document Format
PDG
Pharmacopeial Discussion Group
PDR
Physicians‘ Desk Reference
PDUFA
Prescription Drug User Fee Act (US)
PEI
Paul Ehrlich-Institut (Bundesamt für Sera und Impfstoffe)
PERF
Pan European Regulatory Forum
PET
Positronen-Emissions-Tomographie
PF
Pharmacopée Française
PFD
Process Flow Diagram
Ph Belg
Pharmacopée Belge
Ph Dan
Pharmacopoea Danica
Ph Eur
Pharmacopoea Europaea
Ph F
Pharmacopoea Fennica
Ph Helv
Pharmacopoea Helvetica
Ph Ned
Pharmacopoea Nederladica
Ph Nord
Pharmacopoea Nordica
Ph Norv
Pharmacopoea Norvegica
Ph Svec
Pharmacopoea Svecica
Pharm.Net.- Bund
Arzneimittel-Informationssystem des Bundes und der Länder
PhRMA
Pharmaceutical Research and Manufacturing Association (US)
PHS
Public Health Service (US)
PHSA
Public Health Service Act (FDA)
PhVWP
Pharmacovigilance Working Party
PIC
Pharmaceutical Inspection Convention
PIC/S
Pharmaceutical Inspection Cooperation Scheme
PICSVF
Pharmaceutical Industry Computer Systems Validation Forum (UK)
PID
Process and Instrument Diagram
PIP
Product Improvement Program
PL
Product License
PLA
Produktlinienanalyse
PLA
Product License Application
PLC
Programmable Logic Controller
PLI
Pre-License Inspection (FDA)
PLM
Product Lifecycle Management
PLS
Prozess-Leit-System
PM
Project Manager
PMA
Premarket Approval Application
PMDA
Pharmaceuticals and Medical Devices Agency (Japan)
PMF
Plant Master File
PMS
Postmarketing Surveillance
PMS
Projektmanagementsystem
PNDS
Preclinical New Drug Submission
PoR
Point of Recognition
PPI
Patient Package Insert
PPS
Production Planning System
PQ
Performance Qualification
PQG
Pharmaceutical Quality Group (UK)
PQLI
Product-Quality-Liefecycle-Implementation
PQR
Product Quality Review
PQRI
Product Quality Research Institute (US)
PQS
Pharmaceutical Quality System
PR
Public Relations
PRAC
Pharmacovigilance Risk Assessment Commitee
PSF
Product Specification File
PSJ
Pharmaceutical Society of Japan
PSUR
Periodic Safety Update Report
PTB
Physikalisch-Technische Bundesanstalt
PTO
Patent and Trademark Office (US)
PTPP
Pharmaceutical Target Product Profile
PV
Pharmacovigilance
PV
Process Validation
PV
Prüfungsvorschrift
PVI
Prozess-Vitalitäts-Index
PW
Purified Water
Q
QA
Quality Assurance
QA/RA
Quality Assurance and Regulatory Affairs
QAC
Quality Acceptance Criteria
QAM
Quality Assurance Manual
QAU
Quality Assurance Unit
QbD
Quality by Design
QC
Quality Control
QC
Quality Circle
QCA
Quality Correlation Analysis
QCU
Quality Control Unit
QE
Quality Engineering
QFD
Quality Function Deployment
QHD
Qualified Hygienic Design
QK
Qualitätskontrolle
QKZ
Qualitätskennziffer
QM
Quality Management, Qualitätsmanagement
QMH
Qualitätsmanagementhandbuch
QMP
Qualification Master Plan
QMS
Quality Management System
QP
Qualified Person
QP
Qualitätspolitik
QRD
Quality Review of Documents (EMA)
QRM
Quality Risk Management
QS
Qualitätssicherung
QSB
Qualitätssicherungsbeauftragter
QSH
Qualitätssicherungshandbuch
QSIT
Quality System Inspection Technique (FDA)
QSR
Quality Systems Regulation (FDA)
QSS
Qualitätssicherungssystem
QTPP
Quality Target Product Profile
QU
Quality Unit
QUAL
Qualification
QWBA
Quantitative whole-body autoradiography
QWP
Quality Working Party (CPMP)
R
R & D
Research and Development
R & I-Schema
Rohrleitungs- & Instrumentenschema
RA
Regulatory Affairs
RABC
Risk Analysis and Biocontamination Control
RABS
Restricted Access Barrier System
RAM
Random Access Memory
RAPS
Regulatory Affairs Professionals Society (US)
RARM
Risk Assessment Risk Management
RAS
Rapid Alert System (EU)
RBA
Risk Based Approach
RC
Responsible Care
RCM
Reliability Centered Maintenance
REACH
Registration, Evaluation, Authorisation and Restriction of Chemicals
rDNA
ribosomale DNA
RFID
Radio Frequency Identification
RH
Relative Humidity
Risk MAP
Risk Minimization Action Plan (FDA)
RKI
Robert-Koch-Institut
RL
Regulatory Letter (FDA)
RLT
Raumlufttechnik
RLU
Relative Light Units
RM
Risk Management
RMM
Rapid Microbiological Methods
RMS
Reference Member States
RMS
Regulatory Management System (FDA)
RMS
Risk Management System
ROM
Read-Only Memory
RPN
Risk Priority Number
RPZ
Risikoprioritätszahl
RTP
Rapid Transfer Port
RTRT
Real-Time Release Testing
RTU
Ready to Use
S
SAE
Serious Adverse Events
SAG.E
Senior Advisory Group – Environment (CEFIC)
SAG.T
Senior Advisory Group – Trade (CEFIC)
SAGE
Strategic Advisory Group on Environment
SAL
Sterility Assurance Level
SANCO
Generaldirektion der Europäischen Kommission für Gesundheit und Verbraucher
SAQ
Schweizerische Arbeitsgemeinschaft für Qualitätsförderung
SAT
Site Acceptance Test
SAWG
Scientific Advice Working Group (EMA)
SBA
Summary Basis of Approval
SCA
Supplier Corrective Action
SCADA
Supervisory, Control and Data Acquisition
SCM
Supply Chain Management
SCS
Supply Chain Security
SD
Standard Deviation
SDLC
Systems Development Life Cycle
SDLC
Software Development Life Cycle
SDS
Safety Data Sheet
SDS
Software Design Specification
SE
Standard Error
SELS
Surface Evaluation of Living Skin
SEMI
Semiconductor Equipment and Materials International
SFSTP
Société Francaise des Sciences et Techniques Pharmaceutiques
SG
Sector Group (CEFIC)
SGCI
Schweizerische Gesellschaft für Chemische Industrie
SIL
Safety Integrity Levels
SIP
Sterilization-In-Place
SLA
Service Level Agreement
SMART
Submission Management and Review Tracking (FDA)
SMART
Selfmonitoring and Report Technology
SMF
Site Master File
SMO
Site Management Organization
SmPC
Summary of Product Characteristics
SNDA
Supplemental New Drug Application (FDA)
SNIP
Syndicat National de I’Industrie Pharmaceutique (F)
SOA
Serviceorientierte Architektur
SOP
Standard Operating Procedure
SP
Sachkundige Person
SPC
Statistical Process Control
SPC
Summary of Product Characteristics
SPS
Speicher-programmierbare Steuerung
SQ
Specification Qualification
SQL
Structured Query Language
SRM
Standard Reference Material
SST
System Suitability Test
STT
Short Term Tests
SUPAC
Scale-Up and Post-Approval Changes (FDA)
SVP
Small Volume Parenteral
SWOT
Strengths, Weaknesses, Opportunities, Threats
SWP
Safety Working Party
T
TABD
Trans-Atlantic Business Dialogue
TÄHAV
Verordnung über tierärztliche Hausapotheken
TASC
Technical Affairs Steering Committee (ISO)
TC
Technical Committee (ISO)
TCO
Total-Cost-of-Ownership
TCP/IP
Transmission Control Protocol / Internet Protocol
TDI
Tolerable Daily Intake
TDS
Total Dissolved Solids
TEP
Tender Evaluation Panel (ICH)
TFG
Transfusionsgesetz
TGA
Trägergemeinschaft für Akkreditierung
TGA
Therapeutic Goods Administration (Australia)
TGA
Technische Gebäudeausrüstung
TIA
Totally Integrated Automation
TierImpfStV
Tierimpfstoff-Verordnung
TierSG
Tierseuchengesetz
TM
Test Method
TOC
Total Organic Carbon
TPG
Transplantationsgesetz
TPM
Total Productive Maintenance
TPM
Third Party Manufacturer
TQD
Total Quality Deployment
TQM
Total Quality Management
TSE
Transmissible Spongiforme Enzephalopathy
TTSPP
Time- and Temperature -sensitive Pharmaceutical Product
TVO
Trinkwasserverordnung
TWA
Time Weighted Average
U
UAW
Unerwünschte Arzneimittelwirkungen
UBA
Umweltbundesamt
UEG
Untere Eingriffsgrenze
UF
Ultrafiltration
UIC
Union des Industries Chimiques (F)
UMDNS
Universal Medical Device Nomenclature System
UN
United Nations
UNESCO
United Nations Educational Science and Cultural Organization
UNICE
Union of Industries of the European Community
URS
User Requirement Specification
USC
United States Code (book of laws)
USDA
United States Department of Agriculture
USEPA
United States Environmental Protection Agency
USN
U.S. Adopted Names
USP
Unique Selling Proposition
USP
United States Pharmacopeia
USP-DI
United States Pharmacopoeia-Drug Information
USP-NF
United States Pharmacopoeia-National Formulary
UTG
Untere Toleranzgrenze
UWG
Untere Warngrenze
V
VAI
Voluntary Action Indicated (FDA)
VAL
Validation
VAW
Verfahrensanweisung
VBG
Vorschriftenwerk der Berufsgenossenschaften
VC
Visibly Clean
VC
Visually Clean
VCH
Verlag Chemie
VCI
Verband der Chemischen Industrie e. V.
VDGH
Verband der Diagnostica Industrie e.V.
VDI
Verband Deutscher Ingenieure
VDMA
Verband Deutscher Maschinen- und Anlagenbau e.V.
VFA
Verband Forschender Arzneimittelhersteller e.V.
VHP
Vaporised Hydrogen Peroxide
VMP
Validation Master Plan
VOC
Volatile Organic Compounds
VP
Validation Plan
VR
Validation Report
VwVfG
Verwaltungsverfahrensgesetz
W
WA
Wertanalyse
WAN
Wide Area Network
WBT
Web Based Training
WCB
Working Cell Bank
WDI
Water Distilled
WELMEC
Western European Legal Metrology Cooperation
WFI
Wasser für Injektionszwecke
WHG
Wasserhaushaltsgesetz
WHO
World Health Organization
WIP
Washing-in-Place
WL
Warning Letter (FDA)
WNL
Within Normal Limits
WSD
Working Virus Seed
WSH
Wasser Standardisierter Härte
WSL
Working Seed Lot
WTB
Working Transgenic Bank
WTO
World Trade Organization
WVG
Wissenschaftliche Verlagsgesellschaft Stuttgart
Z
 
ZLG
Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten