Abbreviations used in the GDP Environment
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 | |
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 |
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