Abbreviations in the GDP Environment

Reference Standards - Live Online Training

Recommendation

Tuesday, 4 February 2025 9 .00 - 17.00 h

Reference Standards - Live Online Training
Establishment, Use and Maintenance of Analytical Reference Substances

During GDP events organised by the ECA, the wish came up to compile a list of relevant abbreviations used in the GDP environment. We have prepared such an overview.

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
COA	Certificate of Analysis
CSV	Computer System Validation
DQ	Design Qualification
DSCSA	Drug Supply Chain Security Act
EEA	European Economic Area
EP	European Pharmacopoeia
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
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
WDA	Wholesale Distribution Authorisation

Authorities and Organisations

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/
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
MHRA	Medicines and Healthcare products Regulatory Agency	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
USP	United States Pharmacopeia	www.usp.org
WHO	World Health Organization	www.who.int