GxP
Good ______ Practice or Procedure – GMP, GLP, GCP, GDP
Category: Acronyms
Acronyms that are found in careers working for a pharmaceutical or biotech company.
HACCP
Hazard Analysis & Critical Control Points – is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. -From FDA.gov
IND
Interim New Drug – A submission to the FDA that discloses the manufacturing procedure and all required testing. FDA reviews IND’s in 30-60 days.
ISO
International Organization for Standardization ISO 9000 Quality management ISO 14000 Environmental management ISO 3166 Country codes ISO 26000 Social responsibility ISO 50001 Energy management ISO 31000 Risk management ISO 22000 Food safety management ISO 4217 Currency codes ISO 639 Language codes
LIMS
Laboratory Information Management System
MAC or MACO
Maximum Allowable Carryover
NCTR
National Center for Toxicological Research
NDA or ANDA
New Drug Application – Required prior to offering a new drug to market Abbreviated New Drug Application – Used for the submission of a generic drug application to the FDA
OOS
Out-of-Specification – An event that is not acceptable according to the manufacturing document or other acceptance criteria.
PLC
Programmable Logic Controller – manages computer controlled biotech processes