IMG_2224-2AISI American Iron and Steel Institute
API Active Pharmaceutical Ingredient
ASME American Society Of Mechanical Engineers
ASTM American Society for Testing and Materials
CBER Center for Biologics Evaluation and Research
CDER Center for Drug Evaluation and Research
CDRH Center for Devices and Radiological Health
CIP Clean In Place
COP Clean Out of Place
DQ Design Qualification
EMEA The European Medicines Agency
FAT Factory Acceptance Testing
FDA U. S. Food and Drug Administration
FDS Funtional Design Specification
GAMP Good Automated Manufacturing Practice
GEP Good Engineering Practice
GMP Good Manufacturing Practice
HACCP Hazard Analysis and Critical Control Point
HEPA High Efficiency Particulate Air
HPLC High Pressure Liquid Chromatography
HVAC Heating, Ventilation and Air Conditioning
IQ Installation Qualification
ISPE International Society for Pharmaceutical Engineering
NVOC Non-Volatile Organic Carbon
OOS Out Of Specification
OQ Operational Qualification
P&ID Piping and Instrumentation Diagram
PAT Process Analytical Technology
PDA Parenteral Drug Association
PLC Programmable Logic Controller
PPQ Process Performance Qualification
PQ Performance Qualification
QA Quality Assurance
QC Quality Control
SAT Site Acceptance Testing
SIP Steam/Sterilization In Place
SOP Steam/Sterilization Out of Place
TOC Total Organic Carbon
URS User Requirement Specification
USP United States Pharmacopeia
VMP Validation Master Plan
VP Validation Plan
WFI Water For Injection