Good ______ Practice or Procedure – GMP, GLP, GCP, GDP
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
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.
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
Laboratory Information Management System
Maximum Allowable Carryover
National Center for Toxicological Research
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
Out-of-Specification – An event that is not acceptable according to the manufacturing document or other acceptance criteria.
Programmable Logic Controller – manages computer controlled biotech processes