Destin A. LeBlanc

Cleaning Validation Technologies

Technical Consulting Services

Acronyms

Acronyms that you might find used in cleaning validation

 

AA

 atomic absorption
ADI acceptable daily intake

API

 active pharmaceutical ingredient
ARL acceptable residue limit
BPC bulk pharmaceutical compound (or chemical)

BPE

 bulk pharmaceutical excipient

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

FDA

 Food & Drug Administration

FR

 Federal Register

GCP

 good clinical practices

GLP

 good laboratory practices

GMP

 good manufacturing practices

HPLC

 high performance liquid chromatography

IC

 ion chromatography

IPEC

International Pharmaceutical Excipients Council

ISO

 International Standards Organization

ISPE

International Society for Pharmaceutical Engineering

IVD

 in vitro diagnostic

LD50

 lethal dose fifty percent

MAC

 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

OOS

 out of specification

P&ID

 piping and instrument diagram

PDA

 Parental Drug Association (original meaning; no longer used except as acronym)

PLC

 programmable logic controller
PW purified water
SAL sterility assurance level

SIP

 steam in place, sterilize in place
TLC thin layer chromatography
TOC total organic carbon
USP United States Pharmacopoeia
UV ultraviolet
VOC volatile organic compound
WFI water for injection

Destin A. LeBlanc

Cleaning Validation Technologies

1128 Eagle View Drive

Kodak, TN  37764

Phone:  865-932-6927

Fax:  865-932-6849

click here to contact Destin by email

Hit Counter:  Hit Counter

This page updated:  01/03/08 12:28 PM

Web updated: 7?11?2005

 

Web Master:  Belinda Caylor