20.02.2024

Abbreviations in the GDP Environment - Extended List

Pharma Supply Chain - GDP Requirements and Certification for Logistics Vendors - Live Online Training

Recommendation

Tuesday, 30 April 2024 9 .30 - 16.45 h

Pharma Supply Chain - GDP Requirements and Certification for Logistics Vendors - Live Online Training

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
IQ	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)	https://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)	https://www.hsa.gov.sg/
IATA	International Air Transport Association	https://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)	https://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	https://www.sfda.gov.sa
Swissmedic	Swiss Agency for Therapeutic Products	https://www.swissmedic.ch
TITCK	Turkish Medicines and Medical Devices Agency	https://www.titck.gov.tr/
USP	United States Pharmacopeia	www.usp.org
WHO	World Health Organization	www.who.int