GxP

Good ______ Practice or Procedure – GMP, GLP, GCP, GDP

HACCP

Hazard Analysis & Critical Control Points –┬áis 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

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