|
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 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
|
|
FG: Finished Goods
|
|
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 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
|
Pharmaceutical Updates 
Very Nice Article sir.
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