Pharma Abbreviations
PVP: Process Validation Protocol
PVR: Process Validation Report
CVP: Cleaning Validation Protocol
CVR: Cleaning Validation Report
MQRM: Monthly Quality Review Meeting
QRM: Quality Risk Management
UCL: Upper control Limit
LCL: Lower control Limit
IPQA: In process Quality Assurance
LLC: Live line clearance
API: Active pharmaceutical ingredient
APQR: Annual product Quality review
AQL: Acceptable quality level
ASM: Active Substance Manufacturer
ASMF: Active Substance Master File
AST: Accelerated stability testing
CRT: Controlled Room Temperature
ASTM: American Society for Testing and Materials
BA: Bioavailability
BE: Bioequivalence
BET: Bacterial Endotoxin Test
BMR: Batch Manufacturing Record
BOD: Biological Oxygen Demand
BOM: Bill of Materials
BOPP: Biaxially Oriented Polypropylene
BP: British Pharmacopoeia
BPR: Batch Packaging Record
BSE: Bovine spongiform encephalopathy (mad cow disease)
CAPA: Corrective and preventive action
FMEA: Failure Mode & Effect Analysis
RCA: Root cause Analysis
CBE: Changes being effected
CBER: Center for Biologics Evaluation and Research (FDA)
CCIT: Container closure integrity test
CDER: Center for Drug Evaluation and Research (FDA)
CDSCO: Central drug standard control organization (India)
CEP: Certification of the suitability of European Pharmacopoeia monograph
GC: Gas Chromatography
HSA: Health Sciences Authority, Singapore
ANVISA: Agência Nacional de Vigilância Sanitária (National Health Surveillance Agency Brazil
TGA: Therapeutic goods administration (Australia)
USFDA: United states foods and drugs administration
FDA: Food and Drug Administration, United States
WHO: World Health Organisation
JP: Japanese Pharmacopoeia
MHRA: Medicines and Healthcare products Regulatory Agency (UK)
MEDSAFE: Medicines & medicinal devices safety authority (New Zealand)
CQA: Critical Quality Attribute
MACO: Maximum allowable Carryover
ADE: Adverse drug event
PDE: Permitted Daily Dosage Exposure
ACU: Air Cooling Unit
AHU: Air Handling Unit
ANDA: Abbreviated new drug application
NDA: New drug application
EDMF: European drug master file
EDQM: European Directorate for the Quality of Medicines
EH&S: Environmental health and safety
EIR: Establishment inspection report (FDA)
EMEA: European Medicines Agency
EP: European Pharmacopoeia
ETP: Effluent Treatment Plant
EU: Endotoxin unit
EU: European Union
URS: User Requirement Specification
FAT: Factory Acceptance Testing
SAT: Site Acceptance Test
IQ: Installation Qualification
DQ: Design Qualification
OQ: Operational Qualification
PQ: Performance Qualification
FBD: Fluid-bed dryer
FBP: Fluid-bed Processor
RMG: Rapid mixer Granulator
FDC: Fixed-Dose Combination
FEFO: First expiry first out
FG: Finished Goods
FIFO: First in first out
FMEA: Failure modes and effect analysis
FOI: Freedom of information
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GAMP: Good automated manufacturing practice
GC: Gas Chromatography
GCLP: Good clinical laboratory practice
GCP: Good clinical practice
GDP: Good distribution practice
GEP: Good engineering practice
DOP: Dioctyl Phthalate
GIT: Gastrointestinal Tract
GLP: Good laboratory practice
GMO: Genetically modified organism
GMP: Good manufacturing practice
GPT: Growth Promotion Test
GRAS/E: Generally recognized as safe and effective
GRP: Good review practice
HACCP: Hazard analysis critical control point
HDPE: High-Density Polyethylene
HEPA: High-efficiency particulate air (filter)
HPLC: High-performance liquid chromatography
DHS: Dry heat sterilization
HVAC: Heating, ventilating, and air conditioning
ICH: International Conference on Harmonisation
IH: In house
IM: Intramuscular
IND: Investigational new drug
INDA: Investigational new drug application
IP: Indian Pharmacopeia
IPA: Isopropyl Alcohol
IPS: In-process control
IQ: Installation qualification
IR: Immediate release
ISO: International Organization for Standardization
ISPE: International Society for Pharmaceutical Engineering
IV: Intravenous
KOS: Knowledge organization system
LAF: Laminar airflow
LAL: Limulus Amoebocyte Lysate
LD: Lethal dose
LD50: Lethal dose where 50% of the animal population dies
LDPE: Low-Density Polyethylene
LIMS: Laboratory Information Management System
LIR: Laboratory Investigation Report
LOD: Loss on drying
LOD: Limit of detection
LOQ: Limit of quantification
LR: Laboratory Reagent
LVPs: Large Volume Parenterals
MA: Marketing Authorisation
MAA: Marketing Authorisation Application
MAC: Maximum Allowable Carryover
MCC: Medicines control council (South Africa)
MDD: Maximum daily dose
MFR: Master Formula Record
WL: Warning letter
MOA: Method Of Analysis
MSDS: Material Safety Data Sheets
NCE: New chemical entity
NDA: New Drug Application
NF: National Formulary
NIR: Near Infra-Red Spectroscopy
NON: Notice of non-compliance (Canada)
ODI: Orally Disintegrating Tablet
OQ: Operation Qualification
OSD: Oral Solid Dosage
OSHA: Occupational Safety And Health Administration
OTC: Over-the-counter
OOS: Out of specification
OOT: Out of trend
PAC: Post-approval changes
PAO: Poly alpha olefin
PAT: Process Analytical technology
PET: Preservative efficacy test
PLC: Programmable Logical Control
PVC: Polyvinyl Chloride
PVDC: Polyvinylidene Chloride
PW: Purified Water
QBD: Quality by design
QM: Quality Manual
QMS: Quality Management System
RH: Relative humidity
RLAF: Reverse laminar airflow
RLD: Reference listed drug
RM: Raw material
RM: Packing material
FGS: Finished Goods Store
BSR: Bounded store Room
RO: Reverse Osmosis
RS: Related Substance
SAT: Site Acceptance Testing
SIP: Sterilization in place
SIP: Steam in place
SLS: Sodium Lauryl Sulphate
SMF: Site master file
SOP: Standard operating procedure
SPE: Society for Pharmaceutical Engineering
SUPAC: Scale-up and post-approval changes
SVP: Small Volume Parenteral
TDS: Total Dissolved Solids
TOC: Total organic carbon
TSE: Transmissible spongiform encephalopathy
USP: United States Pharmacopeia
USP-NF: United States Pharmacopeia-National Formulary
CMS: Continuous monitoring system
VMP: Validation Master Plan
WFI: Water for injection
TRF: Test Request Form
CFR: Code of Federal Regulations
CFU: Colony Forming Unit
cGMP: Current Good Manufacturing Practices
CIP: Clean in place
COA: Certificate of analysis
MOA: Method of analysis
COS: Certificate of suitability
COPP: Certificate of Pharmaceutical Products
CPP: Critical Process Parameter
DMF: Drug master file
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