Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services


Acronyms that you might find used in cleaning validation

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