| AA |
atomic absorption |
| ADI |
acceptable daily intake |
| ADE |
acceptable daily exposure |
| API |
active pharmaceutical ingredient |
| ARL |
acceptable residue limit |
| BPC |
bulk pharmaceutical compound (or chemical) |
| BPE |
bulk pharmaceutical excipient |
| CAPA |
corrective and preventive actions |
| CFR |
Code of Federal Regulations |
| CFU |
colony forming unit |
| CGMP |
current good manufacturing practices |
| CIP |
clean in place |
| COP |
clean out of place |
| CTM |
clinical trial material |
| ELSD |
evaporative light scattering detection |
| EP |
European Pharmacopoeia |
| EU |
European Union |
| EU |
endotoxin units |
| FDA |
Food & Drug Administration |
| FR |
Federal Register |
| GCP |
good linical practices |
| GLP |
good laboratory practices |
| GMP |
good manufacturing practices |
| HPLC |
high performance liquid chromatography |
| IC |
ion chromatography |
| ICH |
International Conference on Harmonisation |
| IPEC |
International Pharmaceutical Excipients Council |
| ISO |
International Standards Organization |
| ISPE |
International Society for Pharmaceutical Engineering |
| IVD |
in vitro diagnostic |
| LD50 |
lethal dose fifty percent |
| LOD |
limit of detection |
| LOQ |
limit of quantitation |
| MAC |
maximum allowable carryover |
| MACO |
maximum allowable carryover |
| MOU |
memorandum of understanding |
| MPY |
mils per year |
| MRA |
mutual recognition agreement |
| MSDS |
material safety data sheet |
| NOEL |
no observable effect level |
| NOAEL |
no observable adverse effect level |
| NPOC |
Non-Purgeable Organic Carbon |
| OOS |
out of specification |
| PAT |
process analytical technology |
| PDA |
Parental Drug Association (original meaning; no longer used except as acronym) |
| PDE |
permitted daily exposure |
| PIC/S |
pharmaceutical inspection cooperation scheme |
| P&ID |
piping and instrument diagram |
| PLC |
programmable logic controller |
| PPQ |
process performance qualification |
| PQ |
process qualification |
| PW |
purified water |
| SAL |
sterility assurance level |
| SIP |
steam in place, sterilize in place |
| SOP |
standard operating procedure |
| SUPAC |
scale up and post approval changes |
| TLC |
thin layer chromatography |
| TNTC |
too numerous to count |
| TOC |
total organic carbon |
| TTC |
threshold of toxicological concern |
| USP |
United States Pharmacopoeia |
| UV |
ultraviolet |
| VOC |
volatile organic compound |
| WFI |
water for injection |
