[Last updated: 01-Sep-2018]

This page contains a collection of abbreviations that I have come across during my working life; in the finance and pharmaceutical industries. I have used the web site for some abbreviations, but sometimes, the number of possibilities is excessive.

Note: The letters A, G, N, O, SA and SQ that appear in the second column, indicate the pharmaceutical companies I have worked at; i.e., Astellas (A), GlaxoSmithKline Vaccines (G), Novartis (N), Ono Pharma (O), Sanofi (SA) and Seqirus (SQ) respectively.

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

3SE G Sécurité - Santé - Sûreté - Environnement
5S   Sort, Shine, Set, Standardise, Sustain
AA G Approbation d'Aire (Air Approval)
AAA G Anomalie d'Approbation d'Aire
AAALAC   Association for Assessment and Accreditation of Laboratory Animal Care
AAP   American Academy of Pediatrics
AAR G After Action Review
AAT G Alarm Acceptance Test
Automated Alarm Test(ing)
AAUCMB G Average Area Under the Curve Minus Baseline
AB G AntiBody
ABPI   Association of the British Pharmaceutical Industry
AC/H G Air Changes per Hour (also known as Ventilation Rate per hour)
ACCV G Advisory Commission on Childhood Vaccines
ACI G Air Comprime Instrumentation (pression de 7 bars)
ACL   Active Control List
ACM   Accelerated Change Management
Accelerated Change Methodology
ADMIMO SA Assess, Design, Model, Implement, Monitor and Optimise (from Lean/Six Sigma BPM Methodology)
ADMS A Astellas Document Management System
ADR   Adverse Drug Reaction(s)
AE   Adverse Event
AED SA Authorisations d'Engagement de Dépenses (Expenditure Commitment Authorisation)
AFI   Area For Improvement
AHU   Air Handling Unit
ALMS   Asset Lifecycle Management Solution
AMM A Autorisation de Mise sur le Marché
AMS G Alarms Management System
ANSM A Agence Nationale de Sécurité du Médicament et des produits de santé
APEL A Astellas Pharma Europe Limited
APGD A Astellas Pharma Global Development
API   Active Pharmaceutical Ingredient
AOC A Assistantes Opérations Chimiques
APR   Annual Product Review
AQL   Acceptable Quality Level
AR SA Annual Report
ASL A Affiliate Study Lead
ASMA A Astellas Scientific and Medical Affaires
ASP   Agreed Supply Plan
ASR   Annual Safety Report
ASTM   American Society for Testing and Materials
ATD G Automated Trial Design
ATTP SQ Advanced Track and Trace Pharmaceuticals
ATU A Autorisation Temporaire d’Utilisation
AWS   Analytical Working Standards
BAC   Business Acceptance Criteria
BAM SA Business Activity Monitoring
BB   Black Belt (OE)
BCD   Bouyancy Control Device (SCUBA)
BDC SA Business Decision Committee
BGDT G Biologicals Global Documentation Team
BI   Biological Indicator
BL   Business Lead
BLA G Biologics Licensing Application
BMI   Batch Manufacturing Instructions
Body Mass Index
BO   Business Objects
BOD   Basis of Design
BOG A 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 SA Business Process Management System
BPR   Business Performance Report
BQR SA Business Quality Representative
BRD SA Business Requirements Document
BRP   Business Rediness Process
BSC   Bio Safety Cabinet
BSL   Bio Safety Level
BSTL A Business Supportive Tool
BTD SA Business Technical Document
BUL   Business Acceptance Criteria
CofA   Certificate of Analysis
C&E   Cause and Effect
C&M G Calibration and Measurements
C&MQO SA 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
CAR SA 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 SA 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 SQ Central Entrepreneur
CEC   Coordinateur des Essais Cliniques
CEHS   Corporate Environment Health and Safety
CEO   Chief Executive Officer
CEP SA 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 SA Clinical Information Hub
CIOMS A 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 SA Clinical Compliance Innovation and Training
CLT G 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 SA 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 A 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 O 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 A Clinical Operations Program Lead
COPM SA Clinical Operational Planning Manager
COSHH   Control of Substances Hazardous to Health
CPA SA Clinical Project Assistant
CPL SA Clinical Project Leader
CPM SA Clinical Program Manager
CPMP   Committee On Proprietary Medicinal Products
Comité de Protection des Personnes
Critical Process Parameter
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 SA Clinical Research Assistant/Associate
Corporate Regulatory Affairs
CRF   Case Report/Request Form
Change Request Form
CRO   Contract Research Organisation
CRPV A Centre Régional de Pharmacovigilance
CRU SA Clinical Research Unit
CS&L SQ Customer Services and Logistics
CSA   Customer Service Agreement
CSAM   Clinical Systems Access Management
CSD   Clinical Study Director
CSF   Clinical Study File
CSL SQ Commonwealth Serum Laboratories
CSM   Clinical Study Manager
Customer Supply Management
Clinical Sciences and Operations
Contract Sales Organisation
CSOP SA Clinical Sciences and Operations Platform
CSP SA Clinical Study Protocol
CSR   Clinical Study Report
Customer Services Revenue
CSU SA Clinical Study Unit
CSV   Computerised System Validation: A professional group aimed at the promotion and facilitation of effective computer systems validation
CVSMP   Computerised System Validation Master Plan
CTA SA Clinical Trial Application (to health authorities; similar to IND to FDA)
Clinical Trial Assistant
Clinical Trial Authorisation
CTC SA Clinical Technology Convergence; renamed as UNIFY
CTD   Common Technical Document
CTI   Clinical Trial Information
CTL SA Clinical Trial Leader
CTM SA Clinical Trial Manager/ment
CTMS   Clinical Trial Management System
CTOM SA Clinical Trial Operations Manager
CTP   Clinical Trial Portal
CTQ   Critical to Quality (Lean Six Sigma abbreviation)
CTS O Clinical Trials Supplies
CTSM O Clinical Trials Supplies Manager
CTSP O Clinical Trials Supplies Plan
CTT   Clinical Trial Team
Configuration Transfer Tool
CV   Continuous Validation
CVP   Continuous Validation Plan
CVR G Crawley Validation Report
DBL   Database Lock
DCI   Data Collection Instrument
Dénomination Commune Internationale
DCRF   Data Change Request Form
DCW   Data Collection Workbook
DDD O Drug Development Division
DfS   Drive for Safety
DGCCRF   Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes (French: Directorate General for Competition, Consumer Affairs and Repression of Fraud)
DIAMOND N Data Intelligent Advancement: Management of Novartis Demand
DIB   Development Investment Board
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 SA Document and Content Management
DO   Dangerous Occurrence
DOA   Dead On Arrival
DOE   Design Of Experiments
DOM-TOM   Départements et Territoires d'Outre-Mer
DOMASYS SA Document Management System
DPC   Discrete Particle Counter
DPCF SA Data Protection Consent Form
DPE   Dedicated Project Expert
DPM   Distribution Project Manager
DPTE G Direct Port Transfer Equipment
Double Porte de Transfert Etanche
DQ   Design Qualification
DRC   Direction de Recherche Clinique
DS   Design Specification
DSAR SA Disposition, Safety and Animal Research
DSC   Delivery System Compendia
DSE   Display Screen Equipment
DSM O Drug Safety Manager
DSMB   Data and Safety Monitoring Board
DSO A Drug Safety Officer
DSP A Drug Safety and Pharmacovigilance
DSUR   Development Safety Update Report
DTS SQ Demand to Supply
SQ Demand to Supply - Logistics
Demand to Supply Management
Demand to Supply - Procurement
DSUR O Development SafetyUpdate Report
DVP SA Data Validation Plan
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
EHM   Employee Health Management
EHS   Environment Health and Safety
EIG G Évènements Indésirables Graves
EIGIs   Effets Indésirables Graves Inattendus
EMA   European Medicines Agency
EMEA   Europe, Middle East and Africa
European Medicines Evaluation Agency
EMS   Environment Monitoring System
EP   European Pharmacopoeia
ERA   Excellence Recognition Awards
ERES   Electronic Records and Electronic Signatures. This has been superceeded by RERS
ERP   Enterprise Resource Planning
ES SA Extended Synopsis
ESN   External Supply Network
ESUB   Electronic Submission
ETCM   Engineering Technology and Capital Management
ETEG   Education and Training Export Group
ETL SA Extract, Transform and Load; a type of database e.g., Informatica
ETO   Engineering Technical Operator
Eur. Ph.   European Pharmacopoeia
EVD   Evidence and Value Development
FAQ   Frequently Asked Question
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 SA First Patient, First Treatment
FPFV SA First Patient, First Visit
FPG   Facility and Process Guide
FPI SA First Patient In
FRM A Form
FS   Functional Specification
FTC   Federal Trade Commission
FTE   Full Time Employee
FTM SQ Finance to Manage
FVFS SA First Visit, First Sight/Subject
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 A Global Clinical Pharmacology and Exploratory
GCPL   Global Clinical Pharmacology Lead
GCRQA A Global Clinical and Research Quality Assurance
GD A 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 SQ General Document Routing System
GDS A Global Data Science
GEP   Good Engineering Practice(s)
GIS N Global IT Infrastructure (GITI) Services
GLP   Good Laboratory Practice(s)
GMA SA Global Medical Affairs
GMC   General Medical Council (United Kingdom)
GMD A 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 A Global Medical Writing Lead
GPE   Global Pharmacovigilence and Epidemiology
GPLC   Global Project Life Cycle
GPM   Global Pack Management
GPML   Global Project Management Lead
GPSTL A Global Product Strategy Lead
GPV A Global Pharmacovigilance
GQ   General Qualification
GQA G Global Quality Assurance
GQG G Global Quality Guideline
GQL A Global Quality Lead
GQMP   Global Quality Management Process
GQP G Global Quality Policy
GRA G Global Regulatory Affaires
GRL   Global Regulatory Lead
GSB   Global Safety Board
GSC   Global Supply Chain
GSI   Global Supply Initiative
GSIF SA General Site Information Form
G G GlaxoSmithKline
GSK Bio G 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.]
HA SA Health Authorities
HCP   Healthcare Professional
Sometimes written as Health Care Professional
HDPE   High Density Polyethylene
HEOR A Health Economics and Outcomes Research
HEPA   High Efficiency Particulate Air (filter)
HLRA N High-Level Risk Assessment
HOA   Harmonise, Optimate and Automate
HPLC   High Pressure Liquid Chromatography
HPQC SA HP Quality Centre
HPV   Human Papilloma Virus
HR   Human Resources
HSP SQ Holly Springs
HS&E   Health, Safety and Environment
HVAC   Heating, Ventilating and Air Conditioning (system)
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 N 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 N Information Governance and Management
IMP   Investigational Medicinal Product
IMPACT SA International Management Package for the Administration of Clinical Trials
IMPD SA Investigational Medicinal Product Dossier
IMQC   Incoming Materials Quality Control
IND   Investigational New Drug
INN SA 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 N Innovation, Quality and Productivity
IR   Immediate Release
IRB   Institutional Review Board
IRIN   Integrated Regional Information Networks
ISEC N Information Security
ISF SA Investigator Study File
ISPE   International Society for Pharmaceutical Engineering (Glossary)
ISR A Investigator Sponsored Research
IST SA Investigator Sponsored Trial
ITAG   Intranet Time and Attendance Gold
ITIL   Information Technology Infrastructure Library
IVRS SA Interactive Voice Response System
IWRS SA Interactive Web Response System
JADL   Japan Asia Development Lead
J(F)DI   Just (F***ing) Do It
JIT   Just In Time
JP   Japanese Pharmacopoeia
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&MLS   Leading & Managing Lean Sigma
LAF   Laminar Air Flow
LAL   Limulus Amoebocyte Lysate
LAM   Laboratory Analytical Method
LEV   Local Exhaust (Extract) Ventilation
LIFT G Laboratory Information For Tomorrow (a GSK replacement application for LIMS)
LIMS   Laboratory Information Management System
LIR   Laboratory Investigation Report
LMA SA Local Medical Affairs
LOD   List Of Documents
LPC   Late Pack Customisation
LPFT SA Last Patient, First Treatment
LPI SA Last Patient In
Low Pressure Inflator (SCUBA)
LPL A Local Project Lead
LPLV SA Last Patient, Last Visit
LPT SA Last Patient Treated
LPW   Low Pyrogen-content Water
LRP SA Long Range Plan
LSF SA Local Study File
LSOP   Local Standard Operating Procedure
LSS   Lean Six Sigma
LTA   Lost Time Accident
LVLS SA Last Visit, Last Subject
LVP SQ Liverpool
MA   Medical Advisor
Medical Affairs
MAE A Medical Affairs Europe
MAL   Material Air Lock
MALT A Medical Affaires Leadership Team
MBB   Master Black Belt
MCA   Medicines Control Agency
MDH SQ 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 SQ Maintain to Settle
MUD-ID G Master User Database Identification
MW   Medical Writing
MVR   Monitoring Visit Report
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 N Novartis Operations Center
NP&GS   New Product and Global Supply
NPD   New Product Development
NPI   New Product Introduction
NPL A New Product Lead
NPR   New Pack Request
NPS   New Product Supply
NPV   Net Present Value
NR   Network Rationalisation
NT   Not Tested
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 SA OPX2 (Processes To Improve Matrix Efficiency)
OPEX   Operating Expenses
OQ   Operational Qualification
OQS SA Operational Quality Standards
OSR A Overview of Submitted Expedited Reports
Over The Counter
Order to Cash
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 SA Program Co-ordination Committee
PCD   Pre-Clinical Development
PCR   Primary Clinical Research (Associate)
PD N 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 SA Patient Data Report
PE   Procurement Excellence
PEC SA Program Executive Committee
PEL   Production Equipment Log
PEMS   Particles and Environment Monitoring System
Process Environmental Monitoring System
PESAPL A 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 SA 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 A Policy (document)
POM   UK code for Prescription Only Medicine; Rx in the US
POnA SA 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 SA 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 N Project Documents
PRIST A 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 SA Program Steering Committee
PSDM   Product Standards Document Management
PSR   Product Sourcing Request
PSUR   Periodic Safety Update Report
PT   Product Technology
PTP SQ Procurement to Pay
PTR SA 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&CI SA Quality and Continuous Improvement
QD A Quality Documents
QDoc SA Quality Document
QEP SA Quality Enhancement Plan
QFD   Quality Functional Deployment (Lean Six Sigma)
QG   Quality Group
QIM   Quality In Manufacturing
QIP G Quality Improvement Program
Quality Management (SAP)
Quality Manger
Quality Manual
QMS   Quality Management System
QP   Qualified Person
Quality Systems Document
Quality Standard Document
QSDC A Quality Systems and Document Control
QSR   Qualification Summary Report
QTI   Quality and Technical Information
QTM   Quality and Technical Management
QU   Quality Unit
R&D   Research and Development
RA   Regulatory Affairs
Risk Assessment
RABS   Restricted Access (Area?) Barrier System
RACI   Responsible - Accountable - Consulted - Informed
RAMP SA 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 SA Regional Director of Clinical Development
REC N 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 SA 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 A Répertoire Partagé des Professionnels de Santé
RPS   Respiratory Product Stream
RPV   Responsable de la Pharmacovigilance
RSA   Retired Staff Association
RSD   Regional Supply Director
RSR A Routine System Request
RTC   Respiratory Technology Cell
RTD   Registered Technical Details
Resistance Temperature Detector
RTP G Research Triangle Park
Rx   US code for Prescription Only Medicine; POM in the UK
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 SQ 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 SA Source Document (Patient medical records)
Supporting Documents (Documents than support other quality documents)
SDC   Sapphire Data Collection
SDLC   System Development Life Cycle
SDV   Source Data Verification
SE SA 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 G Sterilisation in Place
SIPOC   Suppliers, Inputs, Process, Outputs and Customers (Lean Six Sigma)
SIRIUS N Secure Infrastructure Readiness for Integrated Virtualisation Services
SISPQ   Safety, Integrity, Strength, Purity and Quality
SIV SA Site Initiation Visit
SKU   Stock Keeping Unit
SLA   Service Level Agreement
SLD N 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 A Sharing Medical Information Logically and Effectively
SML SA Study Management and Logistics
SMP   Strategic Master Plan
SMR   Supplier Managed Replenishment
SOA   Service Orientated Architecture
SOLS   Stock Out Low Stocks
SOM N Service Operations Manual
SOP   Standard Operating Procedure. The following points (from Waymade) might be useful:
  • Successful SOPs are usually constructed in the first instance by individuals who are familiar with the operation or facility in question
  • An SOP should be constructed to reflect a procedure that is currently in practice, or alternatively, can be implemented with the confidence that the SOP can be adhered to consistently over time
  • SOPs should clearly define responsibilities and the process that is to be followed; ambiguity should be avoided
  • An SOP should be 'trained out' to those operatives who are expected to follow and work with the SOP. As an option, operatives who have read an SOP can be asked to complete a short multiple choice test to check that the SOP has been understood. Completion of the training of the SOP should be recorded in the operatives' training records
  • SOPs should include a review and renewal date which could be two (or three (GSK) years from the original date of implementation. During the review process, the content should be updated and revised as necessary. The revised SOP will need to be trained out again.
SOW   Statement of Work
SPC   Statistical Process Control
SPG   Submersible Pressure Gauge (SCUBA)
SPIDER   Site Performance Initiative Delivering Exceptional Responsiveness
SPOC N Single Point Of Contact
SQM   Supplier Quality Management
SR   Study Report
Sustained Release
SRP   Stores Responsible Person
SSO   Single Sign-On
STL A 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&A   Time and Attendance
TA A Therapeutic Area
TAD   Therapeutic Area Director
TAH A Therapeutic Area Head
TAST   Therapeutic Area Strategy Team
TBFW   Team Based Flexible Working
TC   Thermocouple
Topicals & Capsules (Unit)
TDF   Template Data Familiarisation
TDS SA Technical Design Specification
TFF   Tangential Flow Filtration
TILE   Task Individual Load Environment
TIM SA Technology and Information Management
TLC   Thin Layer Chromotography
TLF   Tables, Listings and Figures
TM SA Trial Management
TMA SA Trial Management Associate
TMC   Test Method Compendia
TMF   Trial Master File
TMS   Thesaurus Management System
Time Management System
TNTC   Too Numerous To Count
TO SA 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
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 SA 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 SA United States Regulatory Affairs Marketed Products
USP   United States Pharmacopoeia
VCC N Virtualisation Command Centre
VCF   Vendor Complaint Form
VCO N Vendor Compiance Officer
VF   Visual Factory
VHS N Virtual Hosting Service (Maturation)
VHP   Vapour Hydrogen Peroxide
VMI   Vendor Managed Inventory
VMP   Validation Master Plan
VMR   Validation Master Report
VOB SA Voice of the Business
VOC SA Voice of the Customer
VP   Validation Plan
Vice President
VSR   Value Stream Reporting
VTC   Video Tele Conference
WFI   Water For Injection
WHO   World Health Organisation; Organisation Mondiale de la Santé
WI   Write Idea
WIN SA Work Instruction(s)
WISAT   Worldwide Information Systems Architecture and Technology
WISE SA Worldwide Integrated SAS Environment
WPD A Working Practice Document
WRA   Workplace Risk Assessment
WSI   Written Subject Information
XR   Extended Release



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