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 |