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Honeyman Group  |  Terminology and Abbreviations

 

API

Active Pharmaceutical Ingredient

CCA

Continuous Compliance Assurance

Code of Federal Regulations

cGMP

Current Good Manufacturing Practice

DQ

Design Qualification

Food and Drug Administration

European Medicines Agency

FMEA

Failure Modes and Effects Analysis

GAMP

Good Automated Manufacturing Practice

GCLP

Good Control Laboratory Practice

GMP

Good Manufacturing Practice

HACCP

Hazard Analysis and Critical Control Points

HTM

Health Technical Memorandum

International Conference on Harmonisation

IQ

Installation Qualification

Irish Medicines Board

LAL

Limulus Amoebocyte Lysate

Medicines and Healthcare products Regulatory Agency (formerly the MCA)

OQ

Operational Qualification

Ph Eur

European Pharmacopoeia

PLC

Programmable Logic Controller

PQ

Performance Qualification

QA

Quality Assurance

QC

Quality Control

SOP

Standard Operating Procedure

TOC

Total Organic Carbon

URS

User Requirements Specification

USP

United States Pharmacopoeia

VMP

Validation Master Plan

WFI

Water For Injections

World Health Organisation

Pharmaceutical Water Systems   Sterilisation and Depyrogenation   Analytical Services and Testing 
Pharmaceutical Training Courses   Pharmaceutical Process Consultancy   GMP Regulatory Compliance

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