Abbreviation used in pharma regulatory

abbreviation

Abbreviation

An abbreviation is a shortened form of a word or phrase. It consists of a group of letters taken from the word or phrase. For example, the word abbreviation can itself be represented by the abbreviation abbr., abbrv., or abbrev.

Abbreviation used in pharma regulatory

Abbreviation Full name
M Micron
MCA Medicines Control Agency, now MHRA
ach Air changes per hour
ACOL Acceptable Carry-Over Limit
ADI Acceptable Daily Intake
ADR European Agreement on the Transport of Dangerous Goods by Road
AHU Air Handling Unit
AIM Active Ingredient Manufacturer
ANDA Abbreviated New Drug Application ( USA)
AP Applicant’s Part (of EDMF)
API(s) Active Pharmaceutical Ingredient(s)
APIC Active Pharmaceutical Ingredients Committee of CEFIC (website: http://apic.cefic.org)
APM Asset Performance Management
APR Annual Product Review
AR Annual Report
ASMF Active Substances Master File (Europe)
BACPAC Bulk Actives Post Approval Changes
Bioavailability A measure of extent of drug absorption in the body
Bioequivalence A study to demonstrate the equivalence of 2 medicines
BLA Biologies Licence Application (FDA)
BP British Pharmacopoeia
BPC Bulk Pharmaceutical Chemical ( USA ) – includes Actives and non-Active
BPE Bulk Pharmaceutical Excipients
BMR Batch Manufacturing Record
B Batch
COA Certificate of Analysis
CBE Changes Being Effected (FDA)
CBER Centre for Biologies Evaluation and Research (FDA)
CCP Critical Control Point
CDER Centre for Drug Evaluation and Research
CEP See C of S
CEFIC European Federation of Chemical Industries – Conseil European des Federations de l’Industrie Chimique
CFRs US Code of Federal Regulations
CFU Colony Forming Unit
cGMP current Good Manufacturing Practices
CHMP Committee of Human Medicinal Products – part of EMEA
CIP Clean in Place
CMC Chemistry, Manufacturing and Control section of Registration Dossier
COMAH Control of Major Accident Hazard Regulations
COP Clean Out of Place
COSHH Control of Substances Hazardous to Health
CPMP Committee of Proprietary Medicinal Products now CHMP – part of EMEA
CPG Compliance Policy Guide (FDA)
CPP Critical Process Parameter
CQA Critical Quality Attributes
CT Clinical Trial
CTD Common Technical Document – Dossier for Products – ICH format
CVM Centre for Veterinary Medicines (FDA)
CVMP Committee for Veterinary Medicinal Products – part of EMEA
DI De-ionised (Purified) water
DMF Drug Master File
DOP Dispersed Oil Particulates
DQ Design Qualification
DR Deviation Report
DS Drug Substance
DSM Drug Substance Manufacturer
EAM Enterprise Asset Management
EC European Commission
ECM Enterprise Calibration Management
EDMF European Drug Master File
EDQM European Directive for the Quality of Medicines
EDR Enhanced Design Review
EFD Engineering Flow Diagram
EFPIA European Federation of Pharmaceutical Industries Association
EINECS European Inventory of Existing Commercial Chemical Substances
EIR Establishment Inspection Report (FDA)
ELD Engineering Line Diagram
ELINS European List of Notified (New) Chemical Substances
EMEA European Medicines Agency
ER&S Electronic Records and Signatures
ERA Environmental Protection Agency
ERP Enterprise Resource Planning
EU Endotoxin Unit or European Union
Eudralex Rules Governing Medicinal Products in the European Union (European Drug Regulation Lexicon)
EWG Expert Working Group
FMEA Failure Modes and Effects Analysis
FD and C Act US Federal Food Drug and Cosmetics Act
FD-483 Official FDA form for inspection observations
FDA Food and Drug Administration
FIA Freedom of Information Act ( USA)
FIFO First In First Out
FS Functional Specification, Federal Standard (USA) engineering standards typically
g Gram
GAMP Good Automation Manufacturing Practices
GC Gas Chromatography
GCLP Good Control Laboratories Practices
GCP Good Clinical Practice
GEP Good Engineering Practices
GHS (CPL) Globally Harmonised System of Classification and Labelling of Chemicals (UN)
GLP Good Laboratory Practice (applies to toxicology laboratories/studies)
GMP Good Manufacturing Practice
GxP Good “x” Practices = GMP, GAMP, GCLP, etc.
HACCP Hazard Analysis, Critical Control Point
HAZOP Hazard and Operating Studies
M Micron
HEPA High Efficiency Particulate Air filter
HPLC High Pressure Liquid Chromatography
HR Human Resources
HTM Health Technical Memorandum
HVAC Heating Ventilation and Air Conditioning
IATA International Air Transport Association
ICAO International Civil Aviation Organisation (UN)
ICH International Conference on Harmonisation ( USA , EU, Japan)
IMDG International Maritime Dangerous Goods Code
IMO International Maritime Organisation
IMP(s) Investigational Medicinal Product(s)
IND Investigational New Drug ( USA)
IPC In Process Control
IPPC Integrated Pollution Prevention and Control
IPEC International Pharmaceutical Excipients Council
IQ Installation Qualification
IQA Institute of Quality Assurance (UK) (www.iqa.org)
ISO International Standards Organisation
ISPE International Society of Pharmaceutical Engineers (ww.ispe.org)
IT Information Technology
JP Japanese Pharmacopoeia
Kg Kilogram
LAF Laminar air flow
LD50 Lethal Dose where 50% of the animal population die
LOD Limit of Detection
LOQ Limit of Quantification
MA Manufacturing Authorisation
MAA Marketing Authorisation Application (Europe)
MACOL Maximum Acceptable Carry Over Level
MDD Maximum Daily Dose
Mfg Manufacturing
MHRA Medicines and Healthcare products Regulatory Agency (UK)
Mkg Marketing
ML Manufacturer’s Licence – UK Licence for Medicines Manufacturing sites
MRA Mutual Recognition Agreement
MRO Maintenance Repair and Operations
MRP Manufacturing Resource Planning
MSDS Material Safety Data Sheets
N/A Not Applicable
NASA National Aeronautic and Space Agency ( U.S.A. )
NC Non-clinical (phase, studies)
NCE New Chemical Entity
NDA New Drug Application ( USA)
NF National Formulary ( USA)
NLT or > Not Less Than
NMT or < Not More Than
NOAEL No Observable Adverse Effect Level
NOEL No Observable Effect Level
NONS Notification of New Substances Regulations 1993 (EU)
OE Office of Enforcement, FDA
OEL Occupational Exposure Level
OHH Occupational Health and Hygiene
OOS Out of Specification
OQ Operational Qualification
ORA Office of Regulatory Affairs, FDA
ORO Office of Regional Operations, FDA
OSHA Occupational Safety and Health Administration ( USA )
OTC Over the counter medicine
P&ID Piping and Instrument Drawing
PAD Pharmacological Active Dose
PAI Pre Approval Inspection
PAR Proven Acceptable Range
PAS Prior Approval Supplement (FDA)
PAT Process Analytical Technology
PDA Parenteral Drug Association ( USA)
PDE Permitted Daily Exposure
PFD Process Flow Diagram/Drawing
Ph. Eur. European Pharmacopoeia
PHA (HazAn) Process Hazard Analysis
PhARMA Pharmaceutical Association of Research-based Manufacturers (PMA, USA )
Pharmacokinetics The study of the rate of adsorption of medicines in the body
P-I, P-II, P-III Phase I, Phase II, Phase III (in Clinical Trials)
PIC/S Pharmaceutical Inspection Convention/Cooperation Scheme
PL Product Licence – UK Marketing Authorisation (Dossier)
PLC Programme Logic Controller
PMA Pharmaceutical Manufacturers Association
POM Prescription Only Medicine
ppb Parts per Billion
PPE Personal Protective Equipment
ppm Parts per Million
PPM Planned Preventative Maintenance
PPQ Process Performance Qualification
PQ Performance Qualification or Process Qualification
PQG Pharmaceutical Quality Group (www.pqg.org)
PQR Product Quality Review
PS or P/S Particle Size
PTFE Polytetrafluroethylene
PV Process Validation
QA Quality Assurance
QC Quality Control
QOS Quality Overall Summary (of CTD)
QP Qualified Person
QSIT Quality Systems Inspection Technique
QU Quality Unit
QWP Quality Working Party
R&D Research and Development
RD Registration Dossier
RH Relative Humidity
RO Reverse Osmosis
RM Raw Material
RP Restricted Part (of EDMF)
RSM Registered Starting Material
SHE (or HSE) Safety, Health and Environment
SM Starting Material
SMF Site Master File
SOP Standards Operating Procedure
SPC Summary of Product Characteristics
SPC Statistical Process Control
SUPAC Scale-up, Post Approval Changes (FDA)
TAVC Total Aerobic Viable Count
TDI Tolerable Daily Intake
TGA Therapeutic Goods Agency ( Australia)
TLC Thin Layer Chromatography
TNTC Too Numerous To Count
TOC Total Organic Carbon
TSCA Toxic Substances Control Act 1976 ( USA )
TSE Transmissible Spongiform Encephalopathies (BSE)
TT Technology Transfer
TTR Technology Transfer Reports
TVC Total Viable Counts
U Units
ULPA Ultra Low Particulate Air Filter
URS User Requirement Specification
USP United States Pharmacopoeia
UV Ultra Violet
VMP Validation Master Plan
VOC Volatile Organic Compound
VSR Validation Summary Report
WFI Water for Injection
WHO World Health Organisation

 
these were the popular abbreviation used in pharma industry and these abbreviation are used when creating regulatory documents
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