Abbreviations in the GDP Environment

Recommendation
Monday, 29 September 2025 14.00 - 17.00 h
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 |
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