Abbreviations used in the GDP Environment

The GDP Audit - Live Online Training<br><br>

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3/4 December 2024

The GDP Audit - Live Online Training

How to conduct and pass GDP Audits and Inspections

During several GDP events organized by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. The overview, initially published a few months ago, has now been further expanded.

General Abbreviations

3PL	Third Party Logistics
ALCOA	Attributable, Legible, Contemporaneous, Original, Accurate
ALCOA+	Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available
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
GDocP	Good Documentation Practice
GMP	Good Manufacturing Practices
GSP	Good Storage Practice
HACCP	Hazard Analysis and Critical Control Points
IMP	Investigational Medicinal Product
IQ	Installation Qualification
IoT	Internet of Things
KPI	Key Performance Indicator
LIFO	Last In First Out
MAA	Marketing Authorisation Application
MAH	Marketing Authorisation Holder
MIA	Manufacture and Import Authorisation
MKT	Mean Kinetic Temperature
OOS	Out-of-Specification (test results)
OQ	Operational Qualification
OTC	Over-the-Counter (medications)
Ph. Eur.	European Pharmacopoeia
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
RFID	Radio Frequency Identification
RP	Responsible Person
SDP	Service delivery point
SMF	Site Master File
SOP	Standard Operating Procedure
TCU	Temperature-controlled unit
TOS	Time out of storage
TOR	Time out of refrigeration
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)	www.gov.br/anvisa/pt-br
APIC	Active Pharmaceutical Ingredients Committee	www.apic.cefic.org
DIN	Deutsches Institut für Normung	www.din.de
ECA	European Compliance Academy	www.gmp-compliance.org
EDQM	European Directorate for the Quality of Medicines & HealthCare	www.edqm.eu/en
EMA	European Medicines Agency	www.ema.europa.eu
FDA	U.S. Food and Drug Administration	www.fda.gov
GDPA	European GDP Association	www.good-distribution-practice-group.org
HSA	Health Sciences Authority (Singapore)	www.hsa.gov.sg
IATA	International Air Transport Association	www.iata.org
ICH	International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use	www.ich.org
IPEC	International Pharmaceutical Excipients Council	www.ipec-europe.org
ISO	International Organization for Standardization	www.iso.org
ISPE	International Society for Pharmaceutical Engineering	www.ispe.org
MFDS	Ministry of Food and Drug Safety (Korea)	www.mfds.go.kr
MHRA	Medicines and Healthcare products Regulatory Agency (United Kingdom)	www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
PDA	Parenteral Drug Association	www.pda.org
PIC/S	Pharmaceutical Inspection Co-operation Scheme	www.picscheme.org
SFDA	Saudi Food and Drug Authority	www.sfda.gov.sa
Swissmedic	Swiss Agency for Therapeutic Products	www.swissmedic.ch
TITCK	Turkish Medicines and Medical Devices Agency	www.titck.gov.tr
USP	United States Pharmacopeia	www.usp.org
WHO	World Health Organization	www.who.int