Abbreviations in the GDP Environment - Extended List

During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. The overview first published a few months ago has now been extended.

General Abbreviations

3PL Third Party Logistics
API Active Pharmaceutical Ingredient
CAPA Corrective and Preventive Actions
CC Change Control
CCP Critical Control Point
CFR Code of Federal Regulations
CGMP Current Good Manufacturing Practices
CMO Contract Manufacturing Organization
COA Certificate of Analysis
CRT Controlled Room Temperature
CSV Computer System Validation
DQ Design Qualification
DSCSA Drug Supply Chain Security Act
EEA European Economic Area
EP European Pharmacopoeia
ERP Enterprise Resource Planning
EU European Union
FD&C Act (U.S.) Food, Drug and Cosmetic Act
FEFO First Expiry First Out
FIFO First In First Out
FMEA Failure Mode and Effects Analysis
GDP Good Distribution Practice
GMP Good Manufacturing Practices
GSP Good Storage Practice
HACCP Hazard Analysis and Critical Control Points
IMP Investigational Medicinal Product


Installation Qualification
KPI Key Performance Indicator
LIFO Last In First Out
MAA Marketing Authorisation Application
MAH Marketing Authorisation Holder
MIA Manufacture and Import Authorisation
OOS  Out-of-Specification (test results)
OQ Operational Qualification
OTC Over-the-Counter (medications)
Ph. Eur. European Pharmacopeaia
PQ Performance Qualification
QA Quality Agreement
QA Quality Assurance
QC Quality Control
QM Quality Management
QMS Quality Management System
QP Qualified Person
QRMS Quality and Risk Management System
RA Risk Analysis
RP Responsible Person
SMF Site Master File
SOP Standard Operating Procedure
TTSPP Time and Temperature Sensitive Pharmaceutical Products
WDA Wholesale Distribution Authorisation
WMS Warehouse Management System

Authorities and Organisations

ANVISA Agência Nacional de Vigilância Sanitária (Brazil)
APIC Active Pharmaceutical Ingredients Committee
DIN Deutsches Institut für Normung
ECA European Compliance Academy
EDQM European Directorate for the Quality of Medicines & HealthCare
EMA European Medicines Agency
FDA U.S. Food and Drug Administration
GDPA  European GDP Association
HSA Health Sciences Authority (Singapore)
IATA International Air Transport Association
ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
IPEC International Pharmaceutical Excipients Council
ISO International Organization for Standardization
ISPE International Society for Pharmaceutical Engineering
MFDS Ministry of Food and Drug Safety (Korea)
MHRA Medicines and Healthcare products Regulatory Agency (United Kingdom)
PDA Parenteral Drug Association
PIC/S Pharmaceutical Inspection Co-operation Scheme
SFDA Saudi Food and Drug Authority
Swissmedic Swiss Agency for Therapeutic Products
TITCK Turkish Medicines and Medical Devices Agency
USP United States Pharmacopeia
WHO World Health Organization

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