| Abbreviations |
|
[Last updated: 16-Jan-2021]
This page contains a collection of abbreviations that I have come across during my working life; more recently in the pharmaceutical industry. I have used the acronymfinder.com web site for some abbreviations, but for some of them, the number of listed possibilities is excessive! Many non-pharmaceutical abbreviations were first encountered while working within the I.T. group at KPMG. Where stated, the Pharmaceutical Company column shows the company where the abbreviation seemed to be used the most.
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
| Abbreviation | Pharmaceutical Company | Meaning |
|---|---|---|
| 3SE | GlaxoSmithKline | Sécurité - Santé - Süreté - Environnement |
| 5S | Sort, Shine, Set, Standardise, Sustain | |
| A | ||
| AA | GlaxoSmithKline | Approbation d'Aire (Air Approval) |
| AAA | GlaxoSmithKline | Anomalie d'Approbation d'Aire |
| AAALAC | GlaxoSmithKline | Association for Assessment and Accreditation of Laboratory Animal Care |
| AAP | American Academy of Pediatrics | |
| AAR | GlaxoSmithKline | After Action Review |
| AAT | GlaxoSmithKline | Alarm Acceptance Test Automated Alarm Test(ing) |
| AAUCMB | GlaxoSmithKline | Average Area Under the Curve Minus Baseline |
| AB | GlaxoSmithKline | AntiBody |
| AB-CABS | Rescue Diver Accident Management Acronym: Airway Open Breathing Normally Chest Compressions Airway Open Breathing for the Patient Serious Bleeding, Shock and Spinal Injury/td> | |
| ABPI | Association of the British Pharmaceutical Industry | |
| AC/H | GlaxoSmithKline | Air Changes per Hour (also known as Ventilation Rate per Hour) |
| ACCV | GlaxoSmithKline | Advisory Commission on Childhood Vaccines |
| ACI | GlaxoSmithKline | Air Comprime Instrumentation (pression de 7 bars) |
| ACL | Active Control List | |
| ACM | Accelerated Change Management Accelerated Change Methodology |
|
| ADMIMO | Sanofi | Assess, Design, Model, Implement, Monitor and Optimise (from Lean/Six Sigma BPM Methodology) |
| ADMS | Astellas | Astellas Document Management System |
| ADR | Adverse Drug Reaction(s) | |
| AE | Adverse Event | |
| AED | Sanofi |
Automated External Defibrillator Authorisations d'Engagement de Dépenses (Expenditure Commitment Authorisation) |
| AFI | Area For Improvement | |
| AHU | Air Handling Unit | |
| ALMS | Asset Lifecycle Management Solution | |
| AMM | Astellas | Autorisation de Mise sur le Marché |
| AMS | GlaxoSmithKline | Alarms Management System |
| ANSM | Astellas | Agence Nationale de Sécurité du Médicament et des Produits de Santé |
| APEL | Astellas | Astellas Pharma Europe Limited |
| APGD | Astellas | Astellas Pharma Global Development |
| API | Active Pharmaceutical Ingredient | |
| AOC | Astellas | Assistantes Opérations Chimiques |
| APR | Annual Product Review | |
| AQL | Acceptable Quality Level | |
| AR | Sanofi | Annual Report |
| ASL | Astellas | Affiliate Study Lead |
| ASMA | Astellas | Astellas Scientific and Medical Affaires |
| ASP | Agreed Supply Plan | |
| ASR | Annual Safety Report | |
| ASTM | American Society for Testing and Materials | |
| ATD | GlaxoSmithKline | Automated Trial Design |
| ATTP | Seqirus | Advanced Track and Trace Pharmaceuticals |
| ATU | Astellas | Autorisation Temporaire d’Utilisation |
| AWS | Analytical Working Standards | |
| B | ||
| BAC | Business Acceptance Criteria | |
| BAM | Sanofi | Business Activity Monitoring |
| BB | Black Belt (OE) | |
| BCD | Bouyancy Control Device; as used in SCUBA equipment | |
| BDC | Sanofi | Business Decision Committee |
| BGDT | GlaxoSmithKline | Biologicals Global Documentation Team |
| BI | Biological Indicator | |
| BL | Business Lead | |
| BLA | GlaxoSmithKline | Biologics Licensing Application |
| BMI | Batch Manufacturing Instructions Body Mass Index |
|
| BO | Business Objects | |
| BOD | Basis of Design | |
| BOG | Astellas | Business Operating Guideline |
| BOM | Bill of Materials | |
| BP | British Pharmacopoeia | |
| BPCS | Business Planning and Control System (MRPII) | |
| BPM | Business Process Management | |
| BPMN | Business Process Management Notation | |
| BPMS | Sanofi | Business Process Management System |
| BPR | Business Performance Report | |
| BQR | Sanofi | Business Quality Representative |
| BRD | Sanofi | Business Requirements Document |
| BRP | Business Rediness Process | |
| BSC | Bio Safety Cabinet | |
| BSL | Bio Safety Level | |
| BSTL | Astellas | Business Supportive Tool |
| BTD | Sanofi | Business Technical Document |
| BUL | Business Acceptance Criteria | |
| C | ||
| CofA | Certificate of Analysis | |
| C&E | Cause and Effect | |
| C&M | GlaxoSmithKline | Calibration and Measurements |
| C&MQO | Sanofi | Clinical and Medical Quality Operations |
| CA | Competent Authority | |
| CAG | Compliance Audit Group | |
| CAI | Compressed Air for Instrumentation and Control | |
| CAP | Compendium of Analytical Procedures Compressed Air Process |
|
| CAPA | Corrective Action and Preventative Action | |
| CAPEX | Capital Expenses/Expenditure | |
| CAPH | ||
| CAR | Sanofi | Capital Appropriation Request Clinical Alignment Review |
| CAT | Computer Acceptance Test | |
| CBE-0/30/60 | Changes Being Effective (within 0/30/60 days respectively) | |
| CBT | Computer Based Training | |
| CCIT | Container Closure Integrity Test | |
| CCP | Critical Control Point | |
| CCPP | Comité Consultatif pour la Protection des Personnes | |
| CCTIRS | Comité Consultatif sur le Traitement de l'Information en Matière de Recherche dans le Domaine de la Santé | |
| CCR | Sanofi | Communication and Customer Relation |
| CDA | Confidentiality Disclosure Agreement | |
| CDI | Contrat à Durée Indéterminée | |
| CDLC | Clinical Data Life Cycle | |
| CDMS | Clinical Data Management System | |
| CDP | Clinical Development Plan | |
| CDPI | Capsule Dry Powder Inhaler | |
| CE | Seqirus | Central Entrepreneur |
| CEC | Coordinateur des Essais Cliniques | |
| CEHS | Corporate Environment Health and Safety | |
| CEO | Chief Executive Officer | |
| CEP | Sanofi | Clinical and Exploratory Pharmacology |
| CET | Corporate Executive Team | |
| CFU | Colony Forming Units | |
| CFR | Code of Federal Regulations | |
| cGCP | Current Good Clinical Practice | |
| cGDP | Current Good Distribution Practice Current Good Documentation Practice |
|
| cGLP | Current Good Laboratory Practice | |
| cGMP | Current Good Manufacturing Practice | |
| CI | Continuous Improvement | |
| CIH | Sanofi | Clinical Information Hub |
| CIOMS | Astellas | Council for International Organizations of Medical Sciences |
| CIP | Cleaning In Place; see also SIP. It refers to the process of internally cleaning and sanitizing processing equipment in its assembled position, without the need for dismantling and cleaning of individual parts. | |
| CLAS | Clinical Application and Services | |
| ClinCIT | Sanofi | Clinical Compliance Innovation and Training |
| CLT | GlaxoSmithKline | Crawley Leadership Team |
| CM | Change Management | |
| CMC | Chemistry, Manufacturing and Controls | |
| CMCL | Chemistry, Manufacturing and Control Lead | |
| CMCM | Chemistry, Manufacturing and Control Manager | |
| CMG | Complaints Management Group | |
| CMI | Customer Managed Inventory | |
| CMM | Sanofi | Clinical Monitoring Manager |
| CMMS | Computerised Maintenance Management System | |
| CMO | Contract Manufacturing Organisation | |
| CMR | Customer Managed Replenishment | |
| CMT | Clinical Matrix Team | |
| CMTL | Core Medical Team Lead | |
| CNOM | Astellas | Conseil National de l’Ordre des Médecins |
| CNDM | Comité Nationale de l'Ordre des Médecins | |
| CNIL | Commission Nationale de l'Informatique et des Libertés | |
| CNS | Central Nervous System | |
| CO | Change Over | |
| COA | Certificate Of Analysis | |
| COE | Centre of Excellence | |
| COM | Ono Pharma | Clinical Operations Manager |
| COP | Clean Out of Place. This is an automated or semi-automated procedure in which the process equipment is disassembled and its components are placed into an agitated fluid bath of cleaning solutions. | |
| COPL | Astellas | Clinical Operations Program Lead |
| COPM | Sanofi | Clinical Operational Planning Manager |
| COSHH | Control of Substances Hazardous to Health | |
| CPA | Sanofi | Clinical Project Assistant |
| CPL | Sanofi | Clinical Project Leader |
| CPM | Sanofi | Clinical Program Manager |
| CPMP | Committee On Proprietary Medicinal Products | |
| CPP | Astellas |
Comité de Protection des Personnes Critical Process Parameter |
| CPR | Cardiopulmonary Resuscitation | |
| CPS | Corporate Product Standard | |
| CQA | Critical Quality Attribute | |
| CQG | Clinical Quality and Compliance | |
| CQI | Criticality Quality Index | |
| CQP | Commissioning and Qualification Plan | |
| CR | Controlled Release | |
| CRA | Sanofi | Clinical Research Assistant/Associate Corporate Regulatory Affairs |
| CRF | Case Report/Request Form Change Request Form |
|
| CRO | Contract Research Organisation | |
| CRPV | Astellas | Centre Régional de Pharmacovigilance |
| CRU | Sanofi | Clinical Research Unit |
| CS&L | Seqirus | Customer Services and Logistics |
| CSA | Customer Service Agreement | |
| CSAM | Clinical Systems Access Management | |
| CSD | Clinical Study Director | |
| CSF | Clinical Study File | |
| CSL | Seqirus | Commonwealth Serum Laboratories, Melbourne, Australia |
| CSM | Clinical Study Manager Customer Supply Management |
|
| CSO | Sanofi Astellas |
Clinical Sciences and Operations Contract Sales Organisation |
| CSOP | Sanofi | Clinical Sciences and Operations Platform |
| CSP | Sanofi | Clinical Study Protocol |
| CSR | Clinical Study Report Customer Services Revenue |
|
| CSU | Sanofi | Clinical Study Unit |
| CSV | Computerised System Validation: A professional group aimed at the promotion and facilitation of effective computer systems validation | |
| CTA | Sanofi | Clinical Trial Application (to health authorities;
similar to IND to FDA) Clinical Trial Assistant Clinical Trial Authorisation |
| CTC | Sanofi | Clinical Technology Convergence; renamed as UNIFY |
| CTD | Common Technical Document | |
| CTI | Clinical Trial Information | |
| CTL | Sanofi | Clinical Trial Leader |
| CTM | Sanofi | Clinical Trial Manager/ment |
| CTMS | Clinical Trial Management System | |
| CTOM | Sanofi | Clinical Trial Operations Manager |
| CTP | Clinical Trial Portal | |
| CTQ | Critical to Quality (Lean Six Sigma abbreviation) | |
| CTS | Ono Pharma | Clinical Trials Supplies |
| CTSM | Ono Pharma | Clinical Trials Supplies Manager |
| CTSP | Ono Pharma | Clinical Trials Supplies Plan |
| CTT | Clinical Trial Team Configuration Transfer Tool |
|
| CV | Continuous Validation | |
| CVP | Continuous Validation Plan | |
| CVR | GlaxoSmithKline | Crawley Validation Report |
| CVSMP | Computerised System Validation Master Plan | |
| D | ||
| DBL | Database Lock | |
| DCI | Data Collection Instrument Dénomination Commune Internationale |
|
| DCRF | Data Change Request Form | |
| DCW | Data Collection Workbook | |
| DDD | Ono Pharma | Drug Development Division |
| DfS | Drive for Safety | |
| DGCCRF | Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes (English: Directorate General for Competition, Consumer Affairs and Repression of Fraud) | |
| DIAMOND | Novartis | Data Intelligent Advancement: Management of Novartis Demand |
| DIB | Development Investment Board | |
| DIN | Deutsche Industrie-Norm: a German national standards organization, as used in SCUBA equipment | |
| DITA | Darwin Information Typing Architecture | |
| DM | Data Manager/ment Directeur Médicale |
|
| DMC | Data Monitoring Committee | |
| DMG | Data Management Group | |
| DMO | Data Management Organisation | |
| DMP | Data Management Plan | |
| DnCM | Sanofi | Document and Content Management |
| DO | Dangerous Occurrence | |
| DOA | Dead On Arrival | |
| DOE | Design Of Experiments | |
| DOM-TOM | Départements-Territoires d'Outre-Mer | |
| DOMASYS | Sanofi | Document Management System |
| DPC | Discrete Particle Counter | |
| DPCF | Sanofi | Data Protection Consent Form |
| DPE | Dedicated Project Expert | |
| DPM | Distribution Project Manager | |
| DPTE | GlaxoSmithKline | Direct Port Transfer Equipment Double Porte de Transfert Etanche |
| DQ | Design Qualification | |
| DRC | Direction de Recherche Clinique | |
| DS | Design Specification | |
| DSAR | Sanofi | Disposition, Safety and Animal Research |
| DSC | Delivery System Compendia | |
| DSE | Display Screen Equipment | |
| DSM | Ono Pharma | Drug Safety Manager |
| DSMB | Data and Safety Monitoring Board | |
| DSO | Astellas | Drug Safety Officer |
| DSP | Astellas | Drug Safety and Pharmacovigilance |
| DSUR | Development Safety Update Report | |
| DTS | Seqirus | Demand to Supply |
| DTS-L DTS-M DTS-P |
Seqirus | Demand to Supply - Logistics Demand to Supply Management Demand to Supply - Procurement |
| DSUR | Ono Pharma | Development SafetyUpdate Report |
| DVP | Sanofi | Data Validation Plan |
| E | ||
| E&S | Environment and Safety Group | |
| E&T | Engineering & Technology | |
| EA | Enterprise Architecture | |
| EAP | Employee Assistance Programme | |
| EAT | Electronic Art Transfer | |
| EC | Ethics Committee | |
| ECC | Engineering Change Control Error Checking Control |
|
| ECG | Electrocardiogram | |
| ECRF | Electronic Case Report Form | |
| ECTD | Electronic Common Technical Document | |
| EDC | Electronic Data Capture | |
| EDI | Eau Deionisé (De-ionised water) | |
| EDL | Electronic Data Library | |
| EDMS | Electronic Document Management System | |
| EDS | Electronic Document Specialist | |
| EFES | Engineering Facilities Environment and Safety | |
| EFR | Emergency First Response | |
| EHM | Employee Health Management | |
| EHS | Environment Health and Safety | |
| EIG | GlaxoSmithKline | Évènements Indésirables Graves |
| EIGIs | Effets Indésirables Graves Inattendus | |
| EMA | European Medicines Agency | |
| EMEA | Europe, Middle East and Africa European Medicines Evaluation Agency |
|
| EMS | Emergency Medical Service Environment Monitoring System |
|
| EMT | Emergency Medical Team/Technician | |
| EP | European Pharmacopoeia | |
| ERA | Excellence Recognition Awards | |
| ERES | Electronic Records and Electronic Signatures. This has been superceeded by RERS | |
| ERP | Enterprise Resource Planning | |
| ES | Sanofi | Extended Synopsis |
| ESN | External Supply Network | |
| ESUB | Electronic Submission | |
| ETCM | Engineering Technology and Capital Management | |
| ETEG | Education and Training Export Group | |
| ETL | Sanofi | Extract, Transform and Load; a type of database e.g., Informatica |
| ETO | Engineering Technical Operator | |
| Eur. Ph. | European Pharmacopoeia | |
| EVD | Evidence and Value Development | |
| F | ||
| FAQ | Frequently Asked Question | |
| FAST | Stroke Symptoms: Face - Does one side of face drop? Arms - Does one arm drift downward? Speech - Is speech slurred or strange? Time - If any of these signs are observed, call the EMS |
|
| FAT | Factory Acceptance Tests | |
| FC | Fine Chemicals | |
| FDA | Food and Drug Administration (US regulatory body) | |
| FDS | Functional Design Specification | |
| FED | Front End Design | |
| FES | Fire and Evacuation System | |
| FIP | Finance Improvement Programme | |
| FIT | Finance and Information Technology | |
| FMEA | Failure Modes Effects Analysis | |
| FPAC | Finished Pack | |
| FPFT | Sanofi | First Patient, First Treatment |
| FPFV | Sanofi | First Patient, First Visit |
| FPG | Facility and Process Guide | |
| FPI | Sanofi | First Patient In |
| FRM | Astellas | Form |
| FS | Functional Specification | |
| FTC | Federal Trade Commission | |
| FTE | Full Time Employee | |
| FTM | Seqirus | Finance to Manage |
| FVFS | Sanofi | First Visit, First Sight/Subject |
| G | ||
| GAP | Good Archiving Practice(s) | |
| GAMP | Good Automated Manufacturing Practice(s) | |
| GB | Green Belt | |
| GBP | Global Business Process | |
| GC | Gas Chromatography | |
| GCP | Good Clinical Practice(s) | |
| GCPED | Astellas | Global Clinical Pharmacology and Exploratory |
| GCPL | Global Clinical Pharmacology Lead | |
| GCRQA | Astellas | Global Clinical and Research Quality Assurance |
| GD | Astellas | Global Development |
| GDN | General Despatch Note | |
| GDOL | Global Development Operations Lead | |
| GDP | Good Destruction Practice(s) Good Documentation Practice(s) |
|
| GDPL | Global Development Project Lead | |
| GDRS | Seqirus | General Document Routing System |
| GDS | Astellas | Global Data Science |
| GEP | Good Engineering Practice(s) | |
| GIS | Novartis | Global IT Infrastructure (GITI) Services |
| GLP | Good Laboratory Practice(s) | |
| GMA | Sanofi | Global Medical Affairs |
| GMC | General Medical Council (United Kingdom) | |
| GMD | Astellas | Global Medical and Development |
| GMG | Global Manufacturing Guide | |
| GML | Global Medical Lead | |
| GMO | General Medical Organisation | |
| GMP | Good Manufacturing Practice(s) | |
| GMS | Global Manufacturing and Supply Global Manufacturing Strategy |
|
| GMSCS | Global Manufacturing and Supply Chain Systems | |
| GMWrL | Astellas | Global Medical Writing Lead |
| GPE | Global Pharmacovigilence and Epidemiology | |
| GPLC | Global Project Life Cycle | |
| GPM | Global Pack Management | |
| GPML | Global Project Management Lead | |
| GPSTL | Astellas | Global Product Strategy Lead |
| GPV | Astellas | Global Pharmacovigilance |
| GQ | General Qualification | |
| GQA | GlaxoSmithKline | Global Quality Assurance |
| GQG | GlaxoSmithKline | Global Quality Guideline |
| GQL | Astellas | Global Quality Lead |
| GQMP | Global Quality Management Process | |
| GQP | GlaxoSmithKline | Global Quality Policy |
| GRA | GlaxoSmithKline | Global Regulatory Affaires |
| GRL | Global Regulatory Lead | |
| GSB | Global Safety Board | |
| GSC | Global Supply Chain | |
| GSI | Global Supply Initiative | |
| GSIF | Sanofi | General Site Information Form |
| GSK | GlaxoSmithKline | GlaxoSmithKline |
| GSK Bio | GlaxoSmithKline | GlaxoSmithKline Biologicals. Now known as GSK Vaccines |
| GSN | Global Supply Network | |
| GSO | Global Safety Officer | |
| GSOP | Global Standard Operating Procedure | |
| GSTARS | Global Statistical Analysis and Reporting System | |
| GSTATL | Global Statistical Lead | |
| GxP | Good x Practice(s) [where x may be Manufacturing, Distribution, Laboratory, etc.] | |
| H | ||
| HA | Sanofi | Health Authorities |
| HCP | Healthcare Professional Sometimes written as Health Care Professional |
|
| HDPE | High Density Polyethylene | |
| HEOR | Astellas | Health Economics and Outcomes Research |
| HEPA | High Efficiency Particulate Air (filter) | |
| HLRA | Novartis | High-Level Risk Assessment |
| HOA | Harmonise, Optimate and Automate | |
| HPLC | High Pressure Liquid Chromatography | |
| HPQC | Sanofi | HP Quality Centre |
| HPV | Human Papilloma Virus | |
| HR | Human Resources | |
| HSP | Seqirus | Holly Springs |
| HS&E | Health, Safety and Environment | |
| HVAC | Heating, Ventilating and Air Conditioning (system) | |
| I | ||
| IA | Injury Accident | |
| IAPST | International Association for Pharmaceutical Science and Technology; formerly known as the PDA | |
| IAS | International Actives Supply | |
| IB | Investigator Brochure | |
| IBC | Intermediate Bulk Container | |
| IC | Incident Controller | |
| ICE | Novartis | IQP, Crystal and Excellence |
| ICF | Informed Consent Form | |
| ICH | International Conference on Harmonization (US FDA) | |
| ICS | Intercontinental Studies | |
| ICSR | Individual Case Study Report (an adverse event report for an individual patient) | |
| IDG | Intranet Development Group | |
| IDMC | Independent Data Monitoring Committee | |
| IEC | Institutional Ethics Committee | |
| IEL | Independent Ethics Committee | |
| IGM | Novartis | Information Governance and Management |
| IMP | Investigational Medicinal Product | |
| IMPACT | Sanofi | International Management Package for the Administration of Clinical Trials |
| IMPD | Sanofi | Investigational Medicinal Product Dossier |
| IMQC | Incoming Materials Quality Control | |
| IND | Investigational New Drug | |
| INN | Sanofi | International Non-proprietary Names |
| IOCA | Impact of Change Assessment | |
| IPM | Investigational Product Manager | |
| IPN | Internal Problem Notification | |
| IPO | Input - Process - Output | |
| IQ | Installation Qualification | |
| IQP | Novartis | Innovation, Quality and Productivity |
| IR | Immediate Release | |
| IRB | Institutional Review Board | |
| IRIN | Integrated Regional Information Networks | |
| ISEC | Novartis | Information Security |
| ISF | Sanofi | Investigator Study File |
| ISPE | International Society for Pharmaceutical Engineering (Glossary) | |
| ISR | Astellas | Investigator Sponsored Research |
| IST | Sanofi | Investigator Sponsored Trial |
| ITAG | Intranet Time and Attendance Gold | |
| ITIL | Information Technology Infrastructure Library | |
| IVRS | Sanofi | Interactive Voice Response System |
| IWRS | Sanofi | Interactive Web Response System |
| J | JADL | Japan Asia Development Lead |
| J(F)DI | Just (F***ing) Do It | |
| JIT | Just In Time | |
| JP | Japanese Pharmacopoeia | |
| K | ||
| KISS | Keep It Short and Simple Keep It Simple Statistically Keep It Simple, Stupid |
|
| KM | Knowledge Management | |
| KMS | Key Messages Summary | |
| KO | Kick-Off (meeting) | |
| L | ||
| L&MLS | Leading & Managing Lean Sigma | |
| LAF | Laminar Air Flow | |
| LAL | Limulus Amoebocyte Lysate | |
| LAM | Laboratory Analytical Method | |
| LEV | Local Exhaust (Extract) Ventilation | |
| LIFT | GlaxoSmithKline | Laboratory Information For Tomorrow (a GSK replacement application for LIMS) |
| LIMS | Laboratory Information Management System | |
| LIR | Laboratory Investigation Report | |
| LMA | Sanofi | Local Medical Affairs |
| LOD | List Of Documents | |
| LPC | Late Pack Customisation | |
| LPFT | Sanofi | Last Patient, First Treatment |
| LPI | Sanofi | Last Patient In Low Pressure Inflator; as used in SCUBA equipment |
| LPL | Astellas | Local Project Lead |
| LPLV | Sanofi | Last Patient, Last Visit |
| LPT | Sanofi | Last Patient Treated |
| LPW | Low Pyrogen-content Water | |
| LRP | Sanofi | Long Range Plan |
| LSF | Sanofi | Local Study File |
| LSOP | Local Standard Operating Procedure | |
| LSS | Lean Six Sigma | |
| LTA | Lost Time Accident | |
| LVLS | Sanofi | Last Visit, Last Subject |
| LVP | Seqirus | Liverpool |
| M | ||
| MA | Medical Advisor Medical Affairs |
|
| MAE | Astellas | Medical Affairs Europe |
| MAL | Material Air Lock | |
| MALT | Astellas | Medical Affaires Leadership Team |
| MBB | Master Black Belt | |
| MCA | Medicines Control Agency | |
| MDH | Seqirus | Maidenhead |
| MDI | Metered Dose Inhaler | |
| MDPI | Multi-Dose Powder Inhaler | |
| MDR | Meta Data Repository | |
| MEC | Médicaments pour Essais Cliniques | |
| MEF | Manufacturing Excellence Forum | |
| MENA | Middle East/North Africa | |
| MERPS | Manufacturing ERP Solution (also see ERP) | |
| MHRA | Medicines and Healthcare products Regulatory Agency | |
| MLA | Multi Lot Allocation | |
| MO | Medical Officer Medical Operations |
|
| MRP | Manufacturing Resource Planning | |
| MSC | Material Specification Compendia | |
| MSD | Manufacturing Strategy Director | |
| MSDS | Material Safety Data Sheets | |
| MT | Monitoring Team | |
| MTD | Master Technical Dossier | |
| MTF | Manufacturing Task Force | |
| MTS | Seqirus | Maintain to Settle |
| MUD-ID | GlaxoSmithKline | Master User Database Identification |
| MW | Medical Writing | |
| MVR | Monitoring Visit Report | |
| N | ||
| NCE | New Chemical Entity | |
| NDA | New Drug Application Non-Disclosure Agreement |
|
| NES | New Export System | |
| NICE | National Institute for Clinical Excellence | |
| NID | Next Inspection Date | |
| NIMP | Non-Investigational Medicinal Product | |
| NIR | Near Infra Red | |
| NMQA | Non-Manufacturing Quality Assurance | |
| NOS | Novartis | Novartis Operations Center |
| NP&GS | New Product and Global Supply | |
| NPD | New Product Development | |
| NPI | New Product Introduction | |
| NPL | Astellas | New Product Lead |
| NPR | New Pack Request | |
| NPS | New Product Supply | |
| NPV | Net Present Value | |
| NR | Network Rationalisation | |
| NT | Not Tested | |
| O | ||
| O&P | Organisation and People | |
| OC | Oracle Clinical | |
| OD | Organisation Development | |
| OE | Operational Excellence | |
| OEE | Overall Equipment Effectiveness | |
| OHRP | Office of Human Subjects Research Protection | |
| OLIE | On-Line Instant Education | |
| OOH | Out of Hours | |
| OOS | Out Of Specification Out of Stock |
|
| OOT | Out of Trend | |
| OPTIME | Sanofi | OPX2 (Processes To Improve Matrix Efficiency) |
| OPEX | Operating Expenses | |
| OQ | Operational Qualification | |
| OQS | Sanofi | Operational Quality Standards |
| OSR | Astellas | Overview of Submitted Expedited Reports |
| OTC | SQ |
Over The Counter Order to Cash |
| P | ||
| P&ID | Piping and Instrument Diagram Process and Instrument Diagram |
|
| PACER | Purpose, Agenda, Conduct, Expectations and Roles (Lean Six Sigma) | |
| PAI | Pre-Approval Inspection | |
| PAL | Personnel Air Lock | |
| PAO | Pack Amendment Order | |
| PAS | Pharmacode Assignment System Pre-Approval Submission |
|
| PAT | Process Analytical Technology | |
| PCC | Sanofi | Program Co-ordination Committee |
| PCD | Pre-Clinical Development | |
| PCR | Primary Clinical Research (Associate) | |
| PD | Novartis | Process Description |
| PDA | Parenteral Drug Association; now known as the International Association for Pharmaceutical Science and Technology) | |
| PDCA | Plan, Do, Check, Act | |
| PDD | Pharmaceutical Developement Department | |
| PDI | Pre-Delivery Inspection | |
| PDM | Project Demand Manager | |
| PDP | Performance and Development Programme | |
| PDQA | Pharmaceutical Development Quality Assurance | |
| PDR | Sanofi | Patient Data Report |
| PE | Procurement Excellence | |
| PEC | Sanofi | Program Executive Committee |
| PEL | Production Equipment Log | |
| PEMS | Particles and Environment Monitoring System Process Environmental Monitoring System |
|
| PESAPL | Astellas | Product Evaluation System for Astellas Pharma Lead |
| PFG | Part-Finished Goods | |
| Ph. Eur. | European Pharmacopoeia | |
| Pharm Tech | Pharmaceutical Technologies | |
| PI | Physical Inventory Principle Investigator |
|
| PIM | Sanofi | Process Improvement Manager |
| PIP | Project Investment Proposal | |
| PIPG | Product Introduction & Planning Group | |
| PIRC | Product Incident Review Committee | |
| PL | Project Lead(er) | |
| PLC | Programmable Logic Controller | |
| PMB | Product Management Board | |
| PMC | Packing Material Compendia Products Managed Centrally |
|
| PMCPA | Prescription Medicines Code of Practice Authority | |
| PMDI | Pressurised Metered-Dose Inhaler | |
| PMO | Project Management Office | |
| PMQC | Packing Materials Quality Control | |
| PMSRD | Purchased Material Specification Reference Document | |
| PO | Process Owner Purchace Order |
|
| POL | Astellas | Policy (document) |
| POM | UK code for Prescription Only Medicine; Rx in the US | |
| POnA | Sanofi | Process Optimisation and Automation (a work stream of the UNIFY program umbrella) |
| POU | Point Of Use | |
| PPC | Primary Pack Compendia | |
| PPE | Personal Protective Equipment | |
| PPMO | Sanofi | POnA Program Management Office |
| PPR | Periodic Product Review (should replace APR) | |
| PPS | Process and Product Standards | |
| PQ | Performance Qualification (also includes Cleaning
Validation) Production Qualification |
|
| PQIIR | Product Quality Incident Investigation Report | |
| PQMP | Performance Qualification Master Plan | |
| PQS | Product Quality Specification | |
| PRD | Novartis | Project Documents |
| PRIST | Astellas | Process Improvement, Standards and Training |
| PRF | Pack Request Form Product Review Forum |
|
| PROH | Presidents Roll of Honour | |
| PRP | Product Responsible Person | |
| PS | Pure Steam | |
| PSA | Product Supply Area | |
| PSAC | Production Staging Area Controller | |
| PSC | Sanofi | Program Steering Committee |
| PSDM | Product Standards Document Management | |
| PSR | Product Sourcing Request | |
| PSUR | Periodic Safety Update Report | |
| PT | Product Technology | |
| PTP | Seqirus | Procurement to Pay |
| PTR | Sanofi | Patient Transfer Request |
| PTW | Permit To Work | |
| PUL | Process Unit Leader | |
| PV | Pharmacovigilence Process Validation |
|
| PVC | PolyVinyl Chloride | |
| PVdC | PolyVinylidene Chloride | |
| PVMP | Process Validation Master Plan | |
| PW | Purified Water | |
| Q | ||
| Q&CI | Sanofi | Quality and Continuous Improvement |
| QD | Astellas | Quality Documents |
| QDoc | Sanofi | Quality Document |
| QEP | Sanofi | Quality Enhancement Plan |
| QFD | Quality Functional Deployment (Lean Six Sigma) | |
| QG | Quality Group | |
| QIM | Quality In Manufacturing | |
| QIP | GlaxoSmithKline | Quality Improvement Program |
| QM | A |
Quality Management (SAP) Quality Manger Quality Manual |
| QMS | Quality Management System | |
| QP | Qualified Person | |
| QSD | Sanofi Astellas |
Quality Systems Document Quality Standard Document |
| QSDC | Astellas | Quality Systems and Document Control |
| QSR | Qualification Summary Report | |
| QTI | Quality and Technical Information | |
| QTM | Quality and Technical Management | |
| QU | Quality Unit | |
| R | ||
| R&D | Research and Development | |
| RA | Regulatory Affairs Risk Assessment |
|
| RABS | Restricted Access (Area?) Barrier System | |
| RACI | Responsible - Accountable - Consulted - Informed | |
| RAMP | Sanofi | Regulatory Affairs Marketed Products |
| RBM | Risk-Based Monitoring | |
| RCG | Regulatory Conformance Group | |
| RCPL | Regional Clinical Project Leader | |
| RDC | Remote Data Capture Remote Diagnostic Centre |
|
| RDCD | Sanofi | Regional Director of Clinical Development |
| REC | Novartis | Records |
| RELAX | Remote ECG Loading in ASCII/XML | |
| REMATH | Repeated Maintenance of Thesauri | |
| RERS | Regulated Electronic Records and Signatures. This superceeds ERES | |
| RF | Radio Frequency | |
| RFC | Request for Change | |
| RFI | Request for Information | |
| RFT | Right First Time | |
| RFP | Request For Proposal | |
| RFQ | Request For Quotation | |
| RIMP | Regulatory Inspection and Management Process | |
| RIS | Sanofi | Research Information Systems |
| RLS | Restless Leg Syndrome | |
| RMA | Regional Medical Affairs | |
| RM | Remote Monitoring | |
| RMQC | Raw Materials Quality Control | |
| ROC | Responsable des Opérations Cliniques France | |
| ROI | Return on Investment | |
| ROW | Rest Of World | |
| RPC | Request for Process Change | |
| RPE | Respiratory Protective Equipment | |
| RPM | Regional Project Manager | |
| RPPS | Astellas | Répertoire Partagé des Professionnels de Santé |
| RPS | Respiratory Product Stream | |
| RPV | Responsable de la Pharmacovigilance | |
| RSA | Retired Staff Association | |
| RSD | Regional Supply Director | |
| RSR | Astellas | Routine System Request |
| RTC | Respiratory Technology Cell | |
| RTD | Registered Technical Details Resistance Temperature Detector |
|
| RTP | GlaxoSmithKline | Research Triangle Park |
| Rx | US code for Prescription Only Medicine; POM in the UK | |
| S | ||
| S&OP | Sales and Operational Planning | |
| S&P | Scope and Plan | |
| S&RB | Salary Reward Bonus | |
| SaaS | Software as a Service | |
| SAE | Serious Adverse Event Stamped Address Envelope |
|
| SAP | Systems Applications and Processes Systems Applications and Products (name of supplier and software for MRPII, ERP systems) |
|
| SART | Sterile Aseptic Rapid Transfer | |
| SAT | Site Acceptance Testing | |
| SCE | Statistical Computing Environment | |
| SCL | Seqirus | Supply Chain Logistics |
| SCP | Scientific Core Platform Supply Chain Planning |
|
| SCS | Systems and Communications Services | |
| SCT | Study Contact Team | |
| SCUBA | Self-Contained Underwater Breathing Apparatus | |
| SD | Sanofi | Source Document (Patient medical records) SupportingDocuments (Documents than support other quality documents) |
| SDC | Sapphire Data Collection | |
| SDLC | System Development Life Cycle | |
| SDV | Source Data Verification | |
| SE | Sanofi | System Expert |
| SFD | Shop Floor Documents | |
| SHIRT | Shift hours Incident Response Team | |
| SIGREC | Système d’Information et de Gestion de la Recherche et des Essais Cliniques | |
| SIP | GlaxoSmithKline | Sterilisation in Place |
| SIPOC | Suppliers, Inputs, Process, Outputs and Customers (Lean Six Sigma) | |
| SIRIUS | Novartis | Secure Infrastructure Readiness for Integrated Virtualisation Services |
| SISPQ | Safety, Integrity, Strength, Purity and Quality | |
| SIV | Sanofi | Site Initiation Visit |
| SKU | Stock Keeping Unit | |
| SLA | Service Level Agreement | |
| SLD | Novartis | Service/System Lifecycle Documents |
| SLIA | System Level Impact Assessment | |
| SLT | Site Leadership Team | |
| SM | Study Manager | |
| SMC | Site Management Committee | |
| SME | Subject Matter Expert | |
| SMED | Single Minute Exchange of Dies | |
| SMILE | Astellas | Sharing Medical Information Logically and Effectively |
| SML | Sanofi | Study Management and Logistics |
| SMP | Strategic Master Plan | |
| SMR | Supplier Managed Replenishment | |
| SOA | Service Orientated Architecture | |
| SOLS | Stock Out Low Stocks | |
| SOM | Novartis | Service Operations Manual |
| SOP | Standard Operating Procedure. The following points (from
Waymade) might be useful:
|
|
| SOW | Statement of Work | |
| SPC | Statistical Process Control | |
| SPG | Submersible Pressure Gauge; as used in SCUBA equipment | |
| SPIDER | Site Performance Initiative Delivering Exceptional Responsiveness | |
| SPOC | Novartis | Single Point Of Contact |
| SQM | Supplier Quality Management | |
| SR | Study Report Sustained Release |
|
| SRP | Stores Responsible Person | |
| SSO | Single Sign-On | |
| STL | Astellas | Supportive Tool |
| STP | Situation Target Proposal | |
| SUSAD2 | Submission and Statistical Analysis Datasets (V2) | |
| SVMP | Site Validation Master Plan | |
| SVP | Senior Vice President | |
| SWE | Site Working Environment | |
| SWI | Standard Work Instruction | |
| T | ||
| T&A | Time and Attendance | |
| TA | Astellas | Therapeutic Area |
| TAD | Therapeutic Area Director | |
| TAH | Astellas | Therapeutic Area Head |
| TAST | Therapeutic Area Strategy Team | |
| TBFW | Team Based Flexible Working | |
| TC | Thermocouple Topicals & Capsules (Unit) |
|
| TDF | Template Data Familiarisation | |
| TDS | Sanofi | Technical Design Specification |
| TFF | Tangential Flow Filtration | |
| TILE | Task Individual Load Environment | |
| TIM | Sanofi | Technology and Information Management |
| TLC | Thin Layer Chromotography | |
| TLF | Tables, Listings and Figures | |
| TM | Sanofi | Trial Management |
| TMA | Sanofi | Trial Management Associate |
| TMC | Test Method Compendia | |
| TMF | Trial Master File | |
| TMS | Thesaurus Management System Time Management System |
|
| TNTC | Too Numerous To Count | |
| TO | Sanofi | Trial Operations |
| TOC | Total Organic Carbon | |
| TPI | Technical Process Instructions | |
| TPS | Tablets Product Stream | |
| TQM | Total Quality Management | |
| TQP | Trainee Qualified Person | |
| TTC | Tablet Technology Cell | |
| TTS | Technical Terms of Supply | |
| TVAC | Total Viable Aerobic Count | |
| TWA | Time Weighted Average | |
| U | ||
| UAT | User Acceptance Testing | |
| UDD | User Defined Documents | |
| UDF | Unidirectional Air Flow | |
| UF | Ultra-filtration (unit) | |
| UIR | Unusual Incident Report | |
| ULPA | Ultra Low Particulate Air Ultra Low Penetration Air (Filter) |
|
| UNC | Uncountable | |
| UNIFY | Sanofi | UNIFY Program (Clinical Trial Convergence Program) |
| URL | Universal universal Resource Locator | |
| URB | User Requirements Brief | |
| URS | User Requirements Specification | |
| USRA | United States Regulatory Affairs | |
| USRAMP | Sanofi | United States Regulatory Affairs Marketed Products |
| USP | United States Pharmacopoeia | |
| V | ||
| VCC | Novartis | Virtualisation Command Centre |
| VCF | Vendor Complaint Form | |
| VCO | Novartis | Vendor Compiance Officer |
| VF | Visual Factory | |
| VHS | Novartis | Virtual Hosting Service (Maturation) |
| VHP | Vapour Hydrogen Peroxide | |
| VMI | Vendor Managed Inventory | |
| VMP | Validation Master Plan | |
| VMR | Validation Master Report | |
| VOB | Sanofi | Voice of the Business |
| VOC | Sanofi | Voice of the Customer |
| VP | Validation Plan Vice President |
|
| VSR | Value Stream Reporting | |
| VTC | Video Tele Conference | |
| W | ||
| WFI | Water For Injection | |
| WHO | World Health Organisation; Organisation Mondiale de la Santé | |
| WI | Write Idea | |
| WIN | Sanofi | Work Instruction(s) |
| WISAT | Worldwide Information Systems Architecture and Technology | |
| WISE | Sanofi | Worldwide Integrated SAS Environment |
| WPD | Astellas | Working Practice Document |
| WRA | Workplace Risk Assessment | |
| WSI | Written Subject Information | |
| XYZ | ||
| XR | Extended Release | |
 |
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