ANSI

American National Standards Institute

API

Active Pharmaceutical Ingredient

ASTM

American Society for Testing and Materials

CANDA

Computer Assisted New Drug Application

CBER

Center for Biologics Evaluation and Research

CDER

Center for Drug Evaluation and Research

CDRH

Center for Devices and Radiological Health

CDS

Chromatography Data System

CFR

Code of Federal Regulations ( e.g. 21 CFR 11)

CPG

Compliance Policy Guide

CRO

Contract Research Organization

cGMP

Current Good Manufacturing Practice

COA

Certificate of Analysis

COTS

Commercial Off The Shelf

CSV

Computer System Validation

DHHS

Department of Health and Human Services (US)

DQ

Design Qualification

DS

Design Specification

EC

European Community

EDMS

Electronic Document Management System

EIR

Establishment Inspection Report

EMEA

European Agency for the Evaluation of Medical Products

EP

European Pharmacopoeia (Ph.Eur.)

EU

European Union

FDA

Food and Drug Administration

FMEA

Failure Mode and Effects Analysis

FOI (A)

Freedom of Information (Act)

FR

Federal Register

F(D)S

Functional (Design) Specifications

GAMP

Good Automated Manufacturing Practice guidelines

GC

Gas Chromatography

GERM

Good Electronic Record Management

GLP

Good Laboratory Practice

GXP

Good X Practices (clinical, laboratory or manufacturing)

GMP

Good Manufacturing Practice

HACCP

Hazard Analysis Critical Control Point

HPLC

High Pressure Performance Liquid Chromatography

ICH

International Conference on Harmonisation

IND

Investigational New Drug Application

IEEE

Institute of Electrical and Electronic Engineers, Inc.

IQ

Installation Qualification

ISO

International Organization for Standardization

ISPE

International Society of Pharmaceutical Engineers

LAN

Local Area Network

LIMS

Laboratory Information Management System

MHRA

Medicines and Healthcare products Regulatory Agency (UK)

MHLW

Ministry of Health, Labour and Welfare...