Pharmaceutical Manufacturing Abbreviations
Abbreviations used in Pharmaceutical Manufacturing
As we know pharmaceutical manufacturing products i.e. medicines, life saving drugs have very high importance in our life. Today we learn about various abbreviations used in pharmaceutical manufacturing process steps or simply in pharmaceutical manufacturing companies. These short forms are used in every pharmaceutical manufacturing companies like pharmaceutical industry in USA, pharmaceutical industry in India, pharmaceutical industry in France, pharmaceutical industry in Canada, pharmaceutical industry in China, pharmaceutical industry in Japan etc. These short forms are also asked in various pharma interviews. So learn these Pharmaceutical Manufacturing Abbreviations and also share with your science friends working in pharma companies or studying pharmacy.
GMP : Good Manufacturing Practices
cGMP : Current Good Manufacturing Practices
PVP : Process Validation Protocol
PVR : Process Validation Report
CVP : Cleaning Validation Protocol
CVR : Cleaning Validation Report
GDP : Good Documentation Practices
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 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: Therapeutics 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 Carry over
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
RA: Regulatory Affairs
FIFO: First in first out
FMEA: Failure modes and effect analysis
FOI: Freedom of information
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 air flow
LAL: Limulus Amoebocyte Lysate
LD: Lethal dose
LD50: Lethal dose where 50% of the animal population die
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 air flow
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 Pharmacopoeia
USP-NF: United States Pharmacopoeia-National Formulary
API: Active Pharmaceutical Ingredients
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
PMPS: Pharmaceutical Manufacturing Process Steps
MFP: Media Filling Process
SFG: Semi Finished Goods
PM: Preventive Maintenance
SFG: Semi Finished Goods
FG: Finished Goods
NPI: New Product Introduction
PDL: Packaging Development Laboratory
GMP : Good Manufacturing Practices
cGMP : Current Good Manufacturing Practices
PVP : Process Validation Protocol
PVR : Process Validation Report
CVP : Cleaning Validation Protocol
CVR : Cleaning Validation Report
GDP : Good Documentation Practices
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 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: Therapeutics 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 Carry over
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
RA: Regulatory Affairs
FIFO: First in first out
FMEA: Failure modes and effect analysis
FOI: Freedom of information
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 air flow
LAL: Limulus Amoebocyte Lysate
LD: Lethal dose
LD50: Lethal dose where 50% of the animal population die
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 air flow
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 Pharmacopoeia
USP-NF: United States Pharmacopoeia-National Formulary
API: Active Pharmaceutical Ingredients
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
PMPS: Pharmaceutical Manufacturing Process Steps
MFP: Media Filling Process
SFG: Semi Finished Goods
PM: Preventive Maintenance
SFG: Semi Finished Goods
FG: Finished Goods
NPI: New Product Introduction
PDL: Packaging Development Laboratory
Do you know How medicines are manufactured ?
In ancient times people use plants or animals matter to cure some sort of ailment or diseases by using home remedies. But now day’s medicine manufacturing is performed by chemical processing. Learn more about How medicines are manufactured at given below article
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Books to Learn Pharmaceutical Manufacturing
- Global Compliance to Pharmaceutical Good Manufacturing Practice
- Good Manufacturing Practices for Pharmaceuticals: Gmp in Practice
- Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2017
Useful blog. Thanks for sharing
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