Acronym | Meaning |
2016/161/EU | EU Directive on Falsified Medicines |
2D | Two-dimensional |
6σ | Six Sigma |
AAA | Asian Anti-Counterfeit Association |
ABPI | Association of British Pharmaceutical Industries |
AI | Application Identifier |
AIDC | Automatic Identification and Data Capture |
ANVISA | The National Agency of Sanitary Surveillance in Brazil |
API | Active Pharmaceitical Industries |
APR | Annual Product Review |
APS | Advanced Planning and Scheduling |
BPC | Bulk Pharmaceutical Chemicals |
CAPA | Corrective And Preventive Action |
CDRH | Center for Device Evaluation and Radiological Health |
CEN | European Committee for Standardization |
CFDA | China Food and Drug Administration |
CFR | Code of Federal Regulations |
CFR 21 part 11 | CFR Titel 21 part 11 Electronic records, electronic signatures |
CGMP | Current Good Manufacturing Practice |
CIP | Cleaning in Place |
CIS | Clinical Information System |
CMO | Contract Manufacturing Organization |
CoC | Chain of Custody |
CoO | Chain of Ownership |
COP | Cleaning off place |
CPSI | Canadian Patient Safety Institute |
CR | Change Request |
CRO | Contract (Clinical) Research Organisation |
CSV | Computer System Validation |
DCS | Distributed Control System |
DIP | Drying in Place |
DMC | Data Matrix Code |
DSCSA | Drug Supply Chain Security Act |
EBR | Electronic Batch Record |
EDI | Electronic Data Interchange |
EDL | Essential Drug List |
EFPIA | Europ. Federation of Pharmaceutical Industries & Associations |
EHR | Electronic Health Record |
EMA | European Medicines Agency |
eMAR | electronic Medicine Administration Record |
EMVO | European Medicines Verification Organisation |
EMVS | European Medicines Verification System |
EPC | Electronic Product Code |
EPCIS | Electronic Product Code Information Services |
ePedigree | Electronic Pedigree |
ERP | Enterprise Resource Planning |
FAT | Factory Acceptance Test |
FDA | Food and Drug Administration |
FDS | Functional Design Specification |
FMD | Falsified Medicines Directive |
FSD | Functional Specifications Document |
GAMP | Good Automated Manufacturing Practice |
GCP | Good Clinical Practice |
GDSN | Global Data Synchronization Network |
GDTI | Global Document Type Identifier |
GIAI | Global Individual Asset Identifier |
GLN | Global Location Number |
GLP | Good Laboratory Practice |
GMDN | Global Medical Device Nomenclature |
GMP | Good Manufacturing Practice |
GS1 | Organization that develops and maintains widely used codes |
GSM | Global Standard Management Process |
GSRN | Global Service Relationship Number |
GTIN | Global Trade Item Number |
GTSH | Global Traceability Standard for Healthcare |
HDMA | Healthcare Distribution Management Association |
HIT | Healthcare Information Technology |
HMI | Human Machine Interface |
IACC | International Anti-Counterfeiting Coalition |
ICCBBA | International Council for Commonality in Blood Banking Automation, Inc. |
IEC | International Electronical Commission |
IHTSDO | International Health Terminology Standards Development Organization |
IMDRF | International Medical Device Regulators Forum (formerly named GHTF) |
IPC | In Process Control |
ISA | International Society of Automation |
ISO | International Standards Organization |
ISPE | International Society for Pharmaceuticals Engineering |
KPI | Key Performance Indicator |
MAH | Marketing Authorization Holder |
MBR | Master Batch Record |
MES | Manufacturing Execution System |
MRP | Manufacturing Resource Planning |
NCeP | Network Centric ePedigree |
NDA | New Drug Application |
NHRN | National Healthcare Reimbursement Number |
NMVO | National Medicines Verification Organization |
NTIN | National Trade Item Number |
NVS | National Verification System |
OBP | Onboarding Partner |
OCR | Optical Character Recognition |
OCV | Optical Character Verification |
OEE | Overall Equipment Effectiveness |
OEM | Original Equipment Manufacturers |
ONS | Object Name Service |
OPE | Overall Process Effectiveness |
OTC | Over-The-Counter |
PAT | Process Analytical Technology |
PCS | Process Control System |
PIA | Product Identifier Authentication |
PLM | Product Lifecycle Management |
PQR | Product Quality Review |
PRM | Product Requirements Documents |
QA | Quality Assurance |
QFD | Quality Function Deployment |
QP | Qualified Person |
RbE | Review by Exception |
RFC | Remote Function Call |
RFID | Radio Frequency Identification |
ROI | Return on Investment |
RTM | Requirement Traceability Matrix |
Rx Drugs | Prescription Drugs |
SAT | Site Acceptance Test |
SCADA | Supervisory Control and Data Acquisition |
SCM | Supply Chain Management |
SDS | Software Design Specification |
SFC | Sequential Function Chart |
SLA | Service Level Agreement |
SOP | Standard Operating Procedure |
SPC | Statistical Process Control |
SRIN | Service Relation Instance Number |
SSCC | Serial Shipping Container Code |
TCO | Total Cost of Ownership |
TDS | Tag Data Standard |
TPM | Total Productive Maintenance |
TQC | Total Quality Control |
TQM | Total Quality Management |
Traxeed | Serialization Solutions from Level 1 to Level 5 |
UC | Unit Cost |
UDI | Unique Device Identification |
UDID | Unique Device Identification Database |
URS | User Requirement Specification |
WHO | World Health Organization |
WIP | Work in Process |
WR | Work Request |