Abbreviations used in the GDP Environment
Recommendation
6/7 November 2024
Temperature controlled Transports of Medicinal Products
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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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