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API Active Pharmaceutical Ingredient Arzneimittelwirkstoff
BI Biological indicator Biologische Indikatoren
CAPA Corrective and preventive action Korrigierende und präventative Maßnahmen
CFR Code of Federal Registration  
cGMP Current Good Manufacturing Practice  
CIP Cleaning in Place  
CSV Computer System Validation Computersystem Validierung
DQ Design Qualification Design Qualifizierung
EC European Community Europäische Gemeinschaft
EMA European Medicines Agency  
EP European Pharmacopoeia Europäisches Arzneibuch
ER Electronic Records Elektronische Aufzeichnungen
ES Electronic Signatures Elektronische Unterschriften
FAT Factory Acceptance Test  
FDA Food and Drug Administration  
FDS Functional Design Specification  
FMEA Failure Mode and Effects Analysis Fehlermöglichkeits- und -einflussanalyse
FS Functional Specification Funktionelle Spezifikation
GAMP Good Automated Manufacturing Practice  
GMP Good Manufacturing Practice  
HACCP Hazard Analysis and Critical Control Points  
HDS Hardware Design Specification  
ICH International Conference on Harmonisation  
IPC In Process Control In-Prozesskontrolle
IQ Installation Qualification Installationsqualifizierung
ISO International Organization for Standardization  
MV Method Validation  
OQ Operational Qualification Funktionsqualifizierung
PIC/S Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme  
PQ Performance Qualification Leistungsqualifizierung
PV Process Validation Prozessvalidierung
QM Quality Management Qualitätsmanagement
RA Risk Analysis Risikoanalyse
RV Cleaning Validation Reinigungsvalidierung
RP Regional Comission Regierungspräsidium
RTM Requirement-Traceability-Matrix  
SAT Site Acceptance Test  
SDS Software Design Specification  
SOP Standard Operating Procedure Standardvorgehensweise, Arbeitsanweisung
URS User Requirement Specification Benutzeranforderung
USP United States Pharmacopei  
VPHP Vapor Phase Hydrogen Peroxide  
VMP Validation Master Plan