A
AAMI: American Association of Medical Instrumentation
AAPS: American Association of Pharmaceutical Scientists
AAS: Atomic Absorption Spectroscopy
ACPS: Advisory Committee for Pharmaceutical Science
ACTD: ASEAN Common Technical Dossier
ADE: Adverse Drug Event/ Effect
ADR: Adverse Drug Reaction
AHU: Air Handling Unit
AIDS: Acquired Immune Deficiency Syndrome
AISI: American Iron Steel Institute
AMA: Anti-Microbial Agent
ANDA: Abbreviated New Drug Application
ANOVA: Analysis of Variation
ANVISA: Agencia Nacional de Vigilancia Sanitaria
APA: Aseptic Processing Areas
APE: Anti-microbial Preservative Efficacy
API: Active Pharmaceutical Ingredient
APIC: Active Pharmaceutical Ingredients Committee
APR: Annual Product Review
APQR: Annual Product Quality Review
AQL: Acceptable Quality Level
ASME: American Society of Mechanical Engineers Association
ASTM: American Society for Testing and Materials
ATCC: American Type Culture Collection
ATR: Attenuated Total Reference
AZT: International Association for Pharmaceutical Technology
B
BAN: British Approved Name
BBB: Blood Brain Barrier
BCS: Biopharmaceutical Classification System
BDNF: Bangladesh National Formulary
BET: Bacterial Endotoxin Test
BFS: Blow–Fill–Seal
BI: Biologic Indicator
BIER: Biological Indicator Evaluator Resistometer
BIRDEM: Bangladesh Institute of Research and Rehabilitations in Diabetes, Endocrine, and Metabolic Disorder
BLA: Biological License Application
BMR: Batch Manufacturing Record
BMS: Building Management Systems
BNF: British National Formulary
BOD: Biological Oxygen Demand
BP: British Pharmacopoeia
BS: British Standard
BSA: Body Surface Area
BSI: British Standards Institute
BSTI: Bangladesh Standard Testing Institute
BTU: British Thermal Unit
C
CAPA: Corrective and Preventive Action
CAS: Chemical Abstract Service
CBC: Complete Blood Count
CBE: Changes Being Effected
CBER: Center for Biologics Evaluation and Research
CCD: Charge-Coupled Device
CCP: Critical Control Points
CCU: Critical Care Unit
CDER: Center for Drug Evaluation and Research
CDI: Continuous Electrode Ionization
CDRH: Center for Devices and Radiological Health
CDS: Chromatography Data System
CEN: European Committee for Standardization
CFC: Chloro-fluoro-carbon
CFM: Cubic Foot Per Minute
CFP: Criteria for Forward Processing
CFR: Code of Federal Regulations
CFU: Colony Forming Units
cGAMP: Current Good Automated Manufacturing Practice
cGMIP: Current Good Microbiological Practice
cGMP: Current Good Manufacturing Practice
CHD: Coronary Heart Disease
CHF: Congestive Heart Failure
CHO: Chinese Hamster Ovary
CIP: Clean-In-Place/Process
CIS: Commonwealth of Independent States
CIs: Configuration Items
CMO: Contract Manufacturing Organization
CNS: Central Nervous System
COA: Certificate of Analysis
COC: Cyclo-Olefin Copolymer
COD: Chemical Oxygen Demand
Abbreviations from Page 2 (C - D)
COO: Certificate of Origin
COPP: Certificate of Pharmaceutical Product
COS: Certificate of Standards
COX: Cyclo-oxygenase
cP: Centipoise
CPD: Continuing Professional Development
CPD: Cumulative Population Doubling
CPG: Compliance Policy Guide
CPK: Capability Index for Process Average
CpK: Process Capability, Average
CPMP: Committee for Proprietary Medicinal Products
CPP: Critical Process Parameter
cPs: Centipoise Per Second
CQA: Critical Quality Attribute
CRM: Customer Relationship Management
CRS: Chemical Reference Substance
CRT: Cathode Ray Tube
CS: Comparative Study
CSQMP: Computer System Qualification Master Plan
CSV: Computer System Validation
CTD: Common Technical Document
CTM: Clinical Trial Material
CTQs: Critical to Quality Attributes
CV: Coefficient of Variation
CVM: Center for Veterinary Medicine
CVMP: Committee for Veterinary Medical Products
D
DCS: Distributed Control Systems
DEC: Dynamic Environmental Conditioning
DEHP: Di-2-ethylhexyl-phthalate
DESI: Drug Efficacy Study Implementation
DHFR: Dihydrofolate Reductase
DHR: Development History Report
DHSS: Department of Health and Social Security
DI: Direct Impact
DIN: German Institute of Standardization
DIP: Dry Powder Inhaler
DMF: Drug Master File
DNA: De-oxy Ribonuclic Acid
DO: Dissolved Oxygen Concentration
DOE: Design of Experiment
DOP: Dioctyl Phthalate/ Dispersed Oil Particulate
DQ: Design Qualification
DS: Design Specification
DTL: Drug Testing Laboratory
DUT: Device Under Test
DVM: Digital Volt Meter
E
EC: European Community/Commission
ECG: Electro Cardiogram
ECSs: Environmental Control Systems
EDTA: Ethylene Diamine Tetra-acetic Acid
EEC: European Economic Community
EFPIA: European Federation of Pharmaceutical Industries' Associations
EFTA: European Free Trade Association
ELA: Establishment License Application
ELISA: Enzyme-Linked Immunosorbent Assay
ELN: Electronic Laboratory Notebook
EM: Electron Microscope
EMA: European Medicinal Agency
EMEA: European Medicines Evaluation Agency
EMI: Electromagnetic Interference
EMS: Environmental Monitoring System
EMS: Environmental Management System
EOP: End-of-Production
EP: European Pharmacopoeia
EPA: Environmental Protection Act/Agency
EPR: Electron Paramagnetic Resonance
EQ: Equipment Qualification
ERP: Enterprise Resource Planning
FSC: Free Sales Certificate
ESR: Erythrocyte Sedimentation Rate
ETO: Ethylene Oxide
ETP: Effluent Treatment Plant
EU: European Union
EudraNet: European Union Drug Regulatory Network
F
F: Phase Ratio
FAT: Factory Acceptance Test
FDA: Food and Drug Administration
FDIS: Final Draft International Standard
FEFO: First Expired, First Out
FEQ: Facility and Equipment Qualification
FIFO: First in First Out
FIT: Filter Integrity Test
FMEA: Failure Mode and Effects Analysis
FMECA: Failure Modes Effect and Criticality Analysis
FOI: Freedom of Information Act
FTA: Fault Tree Analysis
FTIR: Fourier Transform Infra-Red Spectrometry
FTM: Fluid Thioglycollate Media
FTNIR: Fourner Transform Near Infra Radiation
G
GC: Gas Chromatography
GABA: Gamma Amino Butyric Acid
GAMP: Good Automated Manufacturing Practice
GAT: General Agreement on Tariffs and Trade
GCLP: Good Control Laboratory Practice
GCP: Good Clinical Practice
GDP: Good Distribution/Documentation Practice
GEP: Good Engineering Practice
GHP: Good Hygiene Practice
GLP: Good Laboratory Practice
GMIP: Good Microbiological Practice
GMP: Good Manufacturing Practice
GPS: Global Positioning System
GQS: Global Quality Standards
GRAS: Generally Recognized as Safe
GRN: Goods Received Note
GRP: Good Regulatory Practice
GxP: Good Practices (Manufacturing practice and Laboratory practice)
H
HAART: Highly Active Antiretroviral Therapy
HACCP: Hazard Analysis on Critical Control Points
HAP: Hamster Antibody Production
HASSASSA: Health and Social Services and Social Security Adjudication Act
HAZOP: Hazard Operability Analysis
HBV: Hepatitis B Virus
HCP: Host Cell Proteins
HDPE: High-Density Polyethylene
HEPA: High-Efficiency Particulate Air
HIC: Hydrophobic Interaction Chromatography
HIMA: Health Industry Manufacturers Association
HIV: Human Immunodeficiency Virus
HMI: Human-Machine Interface
HPLC: High Performance (Pressure) Liquid Chromatography
HTST: High Temperature–Short Time
HVAC: Heating, Ventilation and Air Conditioning
I
I/O: Input/Output
IAEA: International Atomic Energy Agency
IBS: Irritable Bowel Syndrome
ICDDRB: International Centre for Diarrhoeal Disease Research Bangladesh
ICH: International Conference on Harmonization
ICS: Integrated Circuit Devices
ICU: Intensive Care Unit
IEC: Ion Exchange Liquid Chromatography
IEEE: Institute of Electrical and Electronic Engineers
IES: Institute of Environmental Sciences
IFPMA: International Federation of Pharmaceutical Manufacturers Associations
IBD: International Business Development
IND: Investigation New Drug
INN: International Non Proprietarily Name
IOQ: Installation and Operation Qualification
IP: Indicative Price
IPA: Isopropyl Alcohol
IPP: Independent Process Parameters
IPQC: In-process Quality Control
IPT: International Press Tooling
IQ: Installation Qualification
IQP: Installation Qualification Plan/Protocol
IR: Infra Red
ISO: International Organization for Standardization
ISPE: International Society for Pharmaceutical Engineering
IT: Information Technology
IU: International Units
IUD: Intrauterine Device
IUPAC: International Union of Pure and Applied Chemistry
J
JIT: Just-in-Time
JP: Japanese Pharmacopoeia
JPMA: Japan Pharmaceutical Manufacturers' Association
JUSE: Union of Japanese Scientists and Engineers
K
K: Retention Factor
KFDA: Koeria Food and Drug Administration
Kpa: Kilopascal
L
LAF: Laminar Air Flow
LAL: Limulus Amebocyte Lysate
LAN: Local Area Network
LC: Liquid Chromatography
LCL: Lower Control Limit
LDPE: Low Density Polyethylene
LIF: Light-Induced Fluorescence
LIFO: Last in First Out
LIMS: Laboratory Information Management System
LLOQ: Lower Limit of Quantification
LOD: Loss on Drying
LPS: Lipopolysaccharide
LSL: Lower Specification Limit
LTSF: Low-Temperature Steam and Formaldehyde
LVP: Large Volume Parenterals
M
MAC: Maximum Allowable Contaminant
MACO: Maximum Allowable Carryover
MAD: Mutual Acceptance of Data
MAP: Mouse Antibody Production
MAS: Microbiological Air Sampler
MC: Moisture Content
MCA: Medicine Control Agency
MCB: Master Cell Bank
MCC: Medicine Control Council
MDI: Metered Dose Inhalers
MEF: Murine Embryonic Fibroblasts
MES: Manufacturing Execution System
MFG: Manufacturing
MHDH: Material Handling Data Sheet
MHLW: Ministry of Health Labor and Welfare
MHRA: Medicine and Healthcare Products Regulatory Agency
MHW: Ministry of Health and Welfare
MIC: Minimum Inhibitory Concentration
MIMS: Monthly Index of Medical Specialties
MLR: Multiple Linear Regressions
MLM: Materials logistics management
MMI: Man–Machine Interface
MMV: Murine Minute Virus
MNC: Multinational Company/Multinational Corporation
MOA: Method of Analysis
MOC: Material of Construction
MOS: Maintenance of Sterility
MPPS: Most-Penetrating Particle Size
MRD: Market Requirements Document
MRDs: Minimum Required Distributions
MRP: Material Requirements Planning
MRI: Magnetic Resonance Imaging
MRL: Maximum Residue Limit
MRP: Maximum Retail Price
MS: Mass Spectrometry
MS&T: Manufacturing Science and Technology
MSC: Minimal Sporocidal Concentration
MSDS: Material Safety Data Sheet
MVP: Master Validation Plan
MW: Molecular Weight
N
NAFTA: North American Free Trade Area
NaOH: Sodium Hydroxide
NCE: New Chemical Entity / Non-Conforming Event
NCR: Non-Conforming Report
NDA: New Drug Application
NDC: National Drug Code
NDIR: Non-Dispersive Infrared
NF: National Formulary
NGT: Nominal Group Technique
NIR: Near Infrared
NIOSH: National Institute of Occupational Safety and Health
NIST: National Institute of Standards and Technology
NLT: Not Less Than
NMR: Nuclear Magnetic Resonance
NMT: Not More Than
NMWCO: Nominal Molecular Weight Cutoff
NPD: New Product Development
NPDWR: National Primary Drinking Water Regulations
NOAEL: No-Observed-Adverse-Effect-Level
NOEL: No Observed Effect Level
NP: Nonperishable
NSAID: Non Steroidal Anti-inflammatory Drug
NTE: Not to Exceed
O
OCDDS: Osmotically Controlled Drug Delivery System
OMS: Order Management System
QMS: Quality Management System
OOS: Out-of-Specification
OPCs: Optical Particle Counters
OPPI: Organization of Pharmaceutical Producers of India
OPT: Osmotic Pump Tablet
OQ: Operational Qualification
OQP: Operational Qualification Plan
ORP: Oxidation–Reduction Potential
ORS: Oral Rehydration Salts/ Saline
OS: Operating System
OSD: Oral Solid Dosage
OSHA: Occupational Health and Safety Act
OST: Oxidizable Substances Test
OTC: Over the Counter
OVI: Organic Volatile Impurity test
O/W: Oil in Water
P
P&D: Penetration and Distribution
P&ID: Process and Instrumentation Drawings
PABA: Para-Aminobenzoic Acid
PAG: Polyacrylamide Gel
PAGE: Polyacrylamide Gel Electrophoresis
PAI: Preapproval Inspection
PAO: Poly-Alpha Olefin
PAT: Process Analytical Technology
PBS: Phosphate-Buffered Saline
PC: Personal Computer
PCA: Principal Components Analysis
PCR: Polymerase Chain Reaction
PCTFE: Poly Chloro Trifluro Ethylene
PDA: Parenteral Drug Association
PDV: Positive Displacement Volumetric
PDR: Physician’s Desk Reference
PEG: Polyethylene Glycol
PEL: Permissible Exposure Limits
PERT: Product-Enhanced Reverse Transcriptase
PET: Polyethylene Terephthalate
PFD: Process Flow Document
PFI: Pharmaceutical Formulation Intermediates
PFSB: Pharmaceutical and Food Safety Bureau
PhRMA: Pharmaceutical Research Manufacturers
PIC: Pharmaceutical Inspection Convention
PIC/S: Pharmaceutical Inspection Co-operation Scheme
PID: Piping and Instrument Diagram
PLC: Programmable Logic Control
PLM: Product Life-Cycle Management
PMA: Pharmaceutical Manufacturers Association
PMDA: Pharmaceuticals and Medical Devices Agency
PMDI: Pressurized Metered Dose Inhaler
PMS: Premenstrual syndrome
PP: Polypropylene
PPIC: Procurement/Production Planning and Inventory Control
PPLM: Product and Process Lifecycle Management
PQS: Pharmaceutical Quality System
PPM: Parts Per Million
PQ: Performance Qualification / Process Qualification
PQA: Preferred Quality Attributes
PQP: Performance Qualification Plan/Protocol
PQPS: Program on Quality Problem Solving
PQRI: Product Quality Research Institute
PRD: Product Requirements Document
PSDS: Product Safety Data Sheet
PSLR: Predicted Spore Logarithmic Reduction
PTFE: Poly-Tetra-Fluoro-Ethylene
PTS: Packaging Technical Sheet
PUD: Peptic Ulcer Diseases
PV: Process Validation
PVC: Polyvinyl Chloride
PVDC: Polyvinylidene Chloride
PVDF: Polyvinylidene Fluoride
PVP: Process Validation Package
Q
QA: Quality Assurance
QC: Quality Control
QIMP: Quick Index of Medical Products and Problem
QMS: Quality Management System
QP: Qualified Person
QRM: Quick Response Manufacturing
QSIT: Quality Systems Inspection Technique
QU: Quality Unit
QWP: Quality Working Party
R
R: Reagent
RCM: Requirements Chain Management
R & D: Research and Development
R/S: Requirements and Specifications
RABS: Restricted Access Barrier System
RBC: Red Blood Cell
RCS: Reuter Centrifugal Sampler
RF: Radio Frequency
RFI: Radio Frequency Interference
RFLP: Restriction Fragment Length Polymorphism
RFP: Request for Proposal
RH: Relative Humidity
RID: Radial Immunodiffusion
RL: Risk Level
RMS: Root Mean Square
RO: Reverse Osmosis
ROPP: Roll-on-Pilfer Proof
RPM: Rotation per Minute
RS: Reference Standards
RTD: Resistance Temperature Detector
RTM: Requirements Traceability Matrix
RTP: Rapid Transport Port
Rx: Take Though
S
SAARC: South Asian Association for Regional Co-operation
SAFMA: South Asian Free Media Association
SAL: Sterility Assurance Level
SAPTA: South Asian Preferential Trade Agreement
SAS: Surface Air System
SAT: Site Acceptance Test
SCADA: Supervisory Control and Data Acquisition system
SF: Safety Factor
SIM: Subscriber Identification Module
SIP: Steam-In-Place/ Sterilization In-Place
SISPQ: Strength, Identity, Safety, Purity or Quality
SDLC: System Development Life Cycle
SDS: System Design Specification
SMS: Short Message Service
SOP: Standard Operating Procedure
SPC: Statistical Process Control
SPM: Strokes per Minute
SPVP: Sterile Process Validation Package
SSS: Sick Sinus Syndrome
STD: Sexually Transmitted Diseases
STEL: Short-Time-Exposure-Limit
SUPAC: Scale Up and Post Approval Changes
SULPA: Super Ultra Low Penetrate Air
SVP: Small Volume Parenterals
T
TAMC: Total Aerobic Microbial Count
TC: Thermocouple
TCA: Transaction Cost Analysis
TDS: Total Dissolved Solids
TGA: Therapeutic Goods Administration
THM: Trihalomethanes
TM: Trace Matrix
TOC: Total Oxidizable Carbon
TPD: Therapeutic Product Directorate
TPM: Turret Per Minute
TPN: Total Parenteral Nutrition
TQM: Total Quality Management
TR: Retention Time / Technical Report
TRIPS: Trade Related Aspects of Intellectual Property Rights
TS: Tensile Strength
TSS: Total Suspended Solids
TYMC: Total Yeasts and Moulds Count
U
UAD: Unidirectional Airflow Devices
UAT: User Acceptance Testing
UCL: Upper Control Limit
UDAF: Unidirectional Air flow
UF: Ultra-filtration
UFRS: User Functional Requirements Specification
UHF: Ultra High Frequency
ULPA: Ultra Low Penetrate Air
UNDP: United Nations Development Programme
UNESCO: United Nations Educational Scientific and Cultural Organization
UNICEF: United Nations International Children Emergency Fund
UPS: Uninterrupted Power System
URS: User Requirements Specification
USAN: United States Approved Names
USP: United State Pharmacopoeia
UV: Ultraviolet
V
V/V: Volume-by-Volume
VIRUS: Vital Information Research Under Seize
VMP: Validation Master Plan
VOC: Volatile Organic Carbons
W
W/O: Water in Oil
W/V: Weight by Volume
WBC: White Blood Cell
WCB: Working Cell Banks
WFI: Water for Injection
WHO: World Health Organization
WIP: Work in Progress/Process
WMS: Welfare Management System
X
XE: Xenon
Y
YTS: Yearly Training Schedule
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