Abbreviations used in the pharmaceutical industry.
| AISI |
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 |
| PQ |
Performance Qualification |
| PV |
Process Validation |
| 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 |
