S.N.

Short Form

Long Form

01

AAMI

American Association of Medical Instrumentation

02

AAMI

American Association of Medical Instrumentation

03

AAPS

American Association of Pharmaceutical Scientists

04

AAS

Atomic Absorption Spectroscopy

05

ACPS

Advisory Committee for Pharmaceutical Science

06

ACTD

 ASEAN Common Technical Dossier

07

ADE

Adverse Drug Event/ Effect

08

ADR

Adverse Drug Reaction

09

AHU

 Air Handling Unit

10

ATDS

Acquired Immune Deficiency Syndrome

11

ATSI

 American lron Steel Institute

12

AMA

 Anti-Microbial Agent

13

ANDA

Abbreviated New Drug Application

14

ANOVA

Analysis of Variation

15

ANVISA

Agencia Nacional de Vigilancia Sanitaria

16

APA

Aseptic Processing Area

17

APE

Anti-microbial Preservative Efficacy

18

API

Active Pharmaceutical Ingredient

19

APIC

 Active Pharmaceutical Ingredients Committee

20

APR

Annual Product Review

21

APQR

Annual Product Quality Review

22

AQL

Acceptable Quality Level

23

ASME

American Society of Mechanical Engineers Association

24

ASTM

American Society for Testing and Materials

25

ATCC

American Type Culture Collection

26

ATR

Attenuated Total Reference

27

AZT

International Association for Pharmaceutical Technology

28

BAN

British Approved Name

29

BBB

Blood Brain Barrier

30

BCS

Biopharmaceutical Classification System

31

BDNE

Bangladesh National Formulary

32

BET

Bacterial Endotoxin Test

33

BFS

Blow-Fill-Seal

34

BI

Biologic Indicator

35

BIRDEM

Bangladesh Institute of Research and Rehabilitations in Diabetes, Endocrine, and Metabolic Disorder

36

BLA

Biological License Application

37

BMR

Batch Manufacturing Record

38

BMS

Building Management Systems

39

PNF

British National Formulary

40

BOD

Biological Oxygen Demand

41

BP

British Pharmacopoeia

42

BS

British Standard

43

BSA

 Body Surface Area

44

BSI

British Standards Institute

45

BSTI

 Bangladesh Standard Testing Institute

46

BTU

 British Thermal Unit

47

CAPA

 Corrective and Preventive Action

48

CAS

 Chemical Abstract Service

49

CBC

Complete Blood Count

50

CBE

Changes Being Effected

51

CBER

Center for Biologics Evaluation and Research

52

CCD

Charge-Coupled Device

53

CCP

 Critical Control Points

54

CCU

Critical Care Unit

55

CDER

Center for Drug Evaluation and Research

56

CDI

Continuous Electrode Ionization

57

CDRH

Center for Devices and Radiological Health

58

CDS

 Chromatography Data System

59

CEN

European Committee for Standardization

60

CFC

 Chloro-fluoro-carbon

61

CFM

Cubic Foot Per Minute

62

CFP

Criteria for Forward Processing

63

CFR

Code of Federal Regulation

64

CFU

Colony Forming Units

65

cGAMP

Current Good Automated Manufacturing Practice

66

cGMP

Current Good Microbiological Practice

67

cGMP

Current Good Manufacturing Practice

68

CHD

Coronary Heart Disease

69

CHF

Congestive Heart Failure

70

CHO

Chinese Hamster Ovary

71

CIP

Clean-In-Place/ Process

72

CIS

 Commonwealth of Independent States

73

CIs:

 Configuration Items

74

CMO:

Contract Manufacturing Organizational

75

CNS:

Central Nervous System

76

COA:

Certificate of Analysis

77

COC:

Cyclo-Olefin Copolymer

78

COD:

 Chemical Oxygen Demand

79

CAPA

Corrective and Preventive Action

80

CAS

 Chemical Abstract Service

81

CBC

Complete Blood Count

82

CBE

Changes Being Effected

83

CBER

 Center for Biologics Evaluation and Research

84

CCD

 Charge-Coupled Device

85

CCP

Critical Control Points

86

CCU

 Critical Care Unit

87

CDER

Center for Drug Evaluation and Research

88

CDRH

Center for Devices and Radiological Health

89

CDS

Chromatography Data System

190

CEN

 European Committee for Standardization

91

CFC

 Chloro-fluoro-carbon

92

CFM

 Cubic Foot Per Minute

93

CFP

Criteria for Forward Processing

94

CHF

 Congestive Heart Failure

94

CHO

Chinese Hamster Ovary

95

CIP

Clean-In-Place/ Process

96

CIS

Commonwealth of Independent States

97

CIs

 Configuration Items

98

CMO

 Contract Manufacturing Organizational

99

CNS

Central Nervous System

100

COA

Certificate of Analysis

101

COC

Cyclo-Olefin Copolymer

102

COD

Chemical Oxygen Demand

104

COO

Certificate of Origin Pharmaceutic

105

COPP

Certificate of Pharmaceutical Product

106

COS

Certificate of Standards

107

COX

Cyclo- oxygenase

108

CPD

Continuing Professional Development

109

CPD

Cumulative Population Doubling

110

CPG

Compliance Policy Guide

111

CPK

 Capability Index for Process Average

112

PC

Process Capability

113

CHMP

Committee for Proprietary Medicinal Products

114

CPP

 Critical Process Parameter

115

CPS

 Centipoise Per Second

116

COA

Critical Quality Attribute

117

CRM

Customer Relationship Management

118

CRS

Chemical Reference Substance

119

CRT

 Cathode Ray Tube

120

CS

Comparative Study

121

CSQMP

Computer System Qualification Master Plan

122

CSV

Computer System Validation

123

CTD

Common Technical Document

124

CTM

Clinical Trial Material

125

CTQS

Critical to Quality Attributes

126

CV

Coefficient of Variation

127

CVM

Center for Veterinary Medicine

128

CVMP

Committee for Veterinary Medical Products

129

DCS

 Distributed Control System

130

DEHP

Dynamic Environmental Conditioning Di-2-ethylhexyl-phthalate

131

DESI

Drug Efficacy Study Implementation

132

DHFR

Dihydrofolate Reductase

133

DHR

Development History Report

134

DHSS

 Department of Health and Social Security

135

DI

Direct Impact

136

DIN

 German Institute of Standardization

137

DIP

Dry Powder

138

DME

Drug Master File

139

DNA

 De-oxy Ribonucleic Acid

140

DO

 Dissolved Oxygen Concentration

141

DOE

Design of Experiment

142

DOP

 Dioctyl Phthalate / Dispersed Oil Particulate

143

DQ

Design Qualification

144

DS

Design Specification

145

DTL

Drug Testing Laboratory

146

DUT

Device Under Test

147

DVM

 Digital Volt Meter

148

EC

European Community/Commission

149

ECG

Electro Cardiogram

150

ECSs

 Environmental Control Systems

151

EDTA

 Ethylene diamine tetra acetic acid

152

EEC

European Economic Community

153

EFPIA

European Federation of Pharmaceutical Industries’ Associations

154

EFTA

 European Free Trade Association

155

ELA

 Establishment License Application

156

ELISA

Enzyme-Linked Immunosorbent Assay

157

ELN

Electronic Laboratory Notebook

158

EM

Electron Microscope

159

EMA

European Medicinal Agency

160

EMEA

European Medicines Evaluation Agency

161

EMI

Electromagnetic Interference

162

EMS

Environmental Monitoring System

163

EMS

Environmental Management System

164

EOP

End-of-Production

165

EP

European Pharmacopoeia

166

EPA

 Environmental Protection Act/Agency

167

EPR

Electron Paramagnetic Resonance

168

EQ

Equipment Qualification

169

ERP

Enterprise Resource Planning

170

FSC

 Free Sales Certificate

171

ESR

Erythrocyte Sedimentation Rate

172

ETO

 Ethylene Oxide

173

ETP

Effluent Treatment Plant

174

EU

European Union

175

FAT

Factory Acceptance Test

176

FDA

Food and Drug Administration

177

FDIS

Final Draft International Standard

178

FEFO

First Expired, First Out

179

FEQ

 Facility and Equipment Qualification

180

FIFO

First in First Out

181

FIT

Filter Integrity Test

182

FMEA

Failure Mode and Effects Analysis

183

FMECA

 Failure Modes Effect and Criticality Analysis

184

FOI

Freedom of Information Act

185

FTA

Fault Tree Analysis

186

FTIR

Fourier Transform Infra-Red Spectrometry

187

FTM

Fluid Thioglycollate Medium

188

FTNIR

 Fourier transform near-infrared spectroscopy

189

GC

Gas Chromatography

190

GABA

Gamma Amino Butyric Acid

191

GAMP

Good Automated Manufacturing Practice

192

CAT

General Agreement on Tariffs and Trade

193

GCLP

Good Control Laboratory Practice

194

GCP

Good Clinical Practice

195

GDP

Good Distribution/ Documentation Practice

196

GEP

Good Engineering Practice

197

GHP

 Good Hygiene Practice

198

GLP

Good Laboratory Practice

199

GMIP

Good Microbiological Practice

200

GMP

 Good Manufacturing Practice

201

GPS

Global Positioning System

202

GỌS

 Global Quality Standards

203

GRAS

 Generally Recognized as Safe

204

GRN

Goods Received Note

205

GRP

Good Regulatory Practice

206

GxP

 Good Practices (Manufacturing practice and Laboratory practice)

207

HAART

Highly Active Antiretroviral Therapy

208

HACCP

Hazard Analysis on Critical Control Point

209

HAP

HAP: Hamster Antibody Production

210

HHASSASSA

Health and Social Services and Social Security Adjudication Act

211

HAZOP

Hazard Operability Analysis

212

HBV

 Hepatitis B Virus

213

HDPE

High-Density Polyethylene

214

HCP

Host Cell Proteins

215

HEPA

High-Efficiency Particulate Air

216

HIC

Hydrophobic Interaction Chromatography

217

HIMA

Health Industry Manufacturers Association

218

HIV

Human Immunodeficiency Virus

219

HPLC

 High Performance (Pressure) Liquid Chromatography

220

HMI

 Human-Machine Interface

221

HVAC

Heating, Ventilation and Air Conditioning

222

HTST

High Temperature-Short Time

223

I/0

Input/output

224

IAEA

International Atomic Energy Agency

225

IBS

 Irritable Bowel Syndrome

226

ICDDRB

 International Centre for Diarrheal Disease Research Bangladesh

227

ICH

 International Conference on Harmonization

228

ICS

Integrated Circuit Devices

229

ICU

Intensive Care Unit

230

EC

Ion Exchange Liquid Chromatography

231

IEEE

Institute of Electrical and Electronic Engineers

232

ARA IES

Institute of Environmental Science

233

IFPMA

International Federation of Pharmaceutical Manufacturers Association

234

IBD

International Business Development

235

IND

 Investigation New Drug

236

INN

International Non Proprietarily Name

237

IOQ

Installation and Operation Qualification

238

IP

Indicative Price

239

IPA

Isopropyl Alcohol

240

IPP

Independent Process Parameter

241

IPQC

In-process Quality Control

242

IPT

International Press Tooling

243

IQ

Installation Qualification

244

IQP

Installation Qualification Plan/Protocol

245

IR

Infra-Red

246

ASO

 International Organization for Standardization

247

ISPE

International Society for Pharmaceutical Engineering

248

IT

Information Technology

249

IU

International Units

250

IUD

 Intrauterine Device

251

IUPAC

International Union of Pure and Applied Chemistry

252

JIT

Just-in-Time

253

JP

Japanese Pharmacopoeia

254

JPMA

 Japan Pharmaceutical Manufacturers’ Association

255

JUSE

 Union of Japanese Scientists and Engineers

256

KDA

Koeria Food and Drug Administrations

257

LAF

Laminar Air Flow

258

LAL

Limulus Amebocyte Lysate)

259

LC

Liquid Chromatography

260

LCL

Lower Control Limit

261

LDPE

Low Density Polyethylene

262

LIF

Light- -Induced Fluorescence

263

LIFO

 Last in First Out

264

LIMS

Laboratory Information Management System

265

LLOQ

Lower Limit of Quantification

266

LOD

Loss on Dry

267

LPS

Lipopolysaccharide

268

LSL

Lower Specification Limit

269

LTSF

 Low- Temperature Steam and Formable

270

LVP

Large Volume Parenteral

271

TAC

Maximum Allowable Contamination

272

MACO

Maximum Allowable Carryover

273

MAD

MAD: Mutual Acceptance of Data

274

MAP

Mouse Antibody Production

275

MAS

Microbiological Air Sampler

276

MC

 Moisture Content

277

MCA

 Medicine Control Agency

278

MCB

Master Cell Bank

279

MCC

Medicine Control Council

280

MDI

Metered Dose Inhalers

281

MEF

Mouse Embryonic Fibroblast

282

MES

 Manufacturing Execution System

283

MFG

Manufacturing

284

MHDH

 Material Handling Data Sheet

285

IHLW

Ministry of Health Labor and Welfare

286

MRA

Medicine and Healthcare Products Regulatory Agency

287

MHW

Ministry of Health and Welfare

288

MIC

Minimum Inhibitory Concentration

289

MIMS

Monthly Index of Medical Specialities

290

MLR

Multiple Linear Regressions

291

MLM

 Materials logistics management

292

MMI

Man-Machine Interface

293

MMV

Murine Minute Virus

294

MNC

Multinational Company/Multinational Corporation

295

MOA

Method of Analysis

296

MOC

Material of Construction

297

MOS

Maintenance of Sterility

298

PS

 Most-Penetrating Particle

299

MRP

 Material Requirements Planning

300

MRI

Magnetic Resonance Imaging

301

MRL

 Maximum Residue Limit

302

MRP

Maximum Retail Price

303

MS

Mass Spectrometry

304

MS&T

Manufacturing Science and Technology

305

MSC

Minimal Sporicidal Concentration

306

MSDS

Material Safety Data Sheet

307

MVP

Master Validation Plan

308

MW

Molecular Weight

309

NAFTA

North American Free Trade Area

310

NaOH

Sodium Hydroxide

311

NCE

New Chemical Entity /Non-Conforming Event

312

NCR

Non-Conforming Report

313

NDA

New Drug Application

314

NDC

National Drug Code

315

NDIR

Non-Dispersive Infrared

316

NF

National Formulary

317

NGT

Nominal Group Technique

318

NIR

 Near Infrared

319

NIOSH

 National Institute of Occupational Safety and Health

320

NIST

National Institute of Standards and Technology

321

NLT

Not Less Than

322

NMR

Nuclear Magnetic Resonance

323

NMT

Not More Than

324

NMWCO

Nominal Molecular Weight

325

NPD

New Product Development

326

NPDWR

National Primary Drinking Water Regulation

327

NOAEL

No-Observed-Adverse-Effect-Level

328

NOEL

No Observed Effect Level

329

NP

Nonperishable

330

NSAID

Non-Steroidal Anti-inflammatory Drug

331

NTE

Not to Exceed

332

OCDDS

 Osmotically Controlled Drug Delivery System

333

OMS

 Order Management System

334

QMS

Quality Management System

335

O0S

 Out-of-Specification

336

OPCs

Optical Particle Counters

337

OPPI

Organization of Pharmaceutical Producers

338

OPT

Osmotic Pump Tablet

339

OQ

 Operational Qualification

340

OQP

Operational Qualification Plan

341

ORP

Oxidation- -Reduction Potential

342

ORS

Oral Rehydration Salts/ Saline

343

OS

Operating System

344

OSD

Oral Solid Dosage

345

OSHA

Occupational Health and Safety Act

346

OST

Oxidizable Substances Test

347

OTC

Over the Counter

348

OVI

Organic Volatile Impurity test

349

o/W

Oil in Water

350

P&D

Penetration and Distribution

351

PABA

Para-Amino benzoic Acid

352

PAG

Polyacrylamide Gel

353

PAGE

 Polyacrylamide Gel Electrophoresis

354

PAI

Preapproval Inspection

355

PAO

 Poly-Alpha Olefin

356

PAT

Process Analytical Technology

357

PBS

Phosphate-Buffered Saline

358

PC

Personal Computer

359

PCA

Principal Components Analysis

360

PCR

Polymerase Chain Reaction

361

PCTFE

Poly Chloro Trifluro Ethylene

362

PDA

Parenteral Drug Association

363

PDV

Positive Displacement Volumetric

364

PDR

Physician’s Desk Reference

365

PEG

Polyethylene Glycol

366

PEL

 Permissible Exposure Limits

367

PERT

 Product-Enhanced Reverse Transcript

368

PET

Polyethylene Terephthalate

369

PFD

Process Flow Document

370

PFI

Pharmaceutical Formulation Intermediate

371

PFSB

Pharmaceutical and Food Safety

372

PRM

Pharmaceutical Research Manufacturer

373

PIC/S

Pharmaceutical Inspection Co-operation Scheme

374

PID

Piping and Instrument Diagram

375

PLC

Programmable Logic Control

376

PLM

Product Life- -Cycle Management

377

PMA

Pharmaceutical Manufacturers Association

378

PMDA

Pharmaceuticals and Medical Devices Agency

379

PMDI

Pressurized Metered Dose Inhaler

380

PMS

Premenstrual syndrome

381

PP

Polypropylene

382

POS

Pharmaceutical Quality System

383

PPM

Parts Per Million

384

PQ

Performance Qualification / Process Qualification

385

PQA

Preferred Quality Attributes

386

PQP

Performance Qualification Plan/ Protocol

387

PQPS

Program on Quality Problem Solving

388

PQRI

Product Quality Research Institute

389

PRD

Product Requirements Document

390

PSDS

Product Safety Data Sheet

391

PSLR

Predicted Spore Logarithmic Reduction

392

PTFE

Poly-Tetra-Fluoro-Ethylene

393

PTS

Packaging Technical Sheet

394

PUD

Peptic Ulcer Diseases

395

PV

Process Validation

396

PVDC

Polyvinylidene Chloride

397

PVDF

Polyvinylidene Fluoride

398

PVC

Polyvinyl chloride

399

PVP

Process Validation Package

400

QA

Quality Assurance

401

QC

Quality Control

402

QIMP

Quick Index of Medical Products and Problem

403

QMS

Quality Management System

404

QP

Qualified Person

405

QRM

Quick Response Manufacturing

406

QSIT

Quality Systems Inspection Technique

407

QU

Quality Unit

408

QWP

Quality Working Party

409

RCM

Requirements Chain Management

410

R & D

Research and Development

411

R/S

Requirements and Specifications

412

RABS

Restricted Access Barrier System

413

RBC

Red Blood Cell

414

RCS

Reuter Centrifugal Sample

415

RF

Radio Frequency

416

RFI

Radio Frequency Interference

417

RFLP

Restriction Fragment Length Polymorphism

418

RFP

Request for Proposal

419

RH

Relative Humidity

420

RID

Radial Immunodiffusion

421

RL

Risk Level

422

RMS

 Root Mean Square

423

RO

Reverse Osmosis

424

ROPP

Roll-on-Pilfer Proof

425

RPM

 Rotation per Minute

426

RS

Reference Standards

427

RTD

Resistance Temperature Detector

428

RTM

Requirements Traceability Matrix

429

RTP

Rapid Transport Port

430

Rx

Take Though

431

SAARC

South Asian Association for Regional Co-operation

432

SAFMA

South Asian Free Media Association

433

SAL

Sterility Assurance Level

434

SAPTA

South Asian Preferential Trade Agreement

435

SAS

 Surface Air System

436

SAT

Site Acceptance Test

437

SCADA

Supervisory Control and Data Acquisition system

438

SF

Safety Factor

439

SIM

Subscriber Identification Module

440

SIP

 Steam-In-Place/ Sterilization In-Place

441

SISPQ

Strength, Identity, Safety, Purity or Quality

442

SDLC

 System Development Life Cycle

443

SDS

System Design Specification

444

SMS

Short Message Service

445

SOP

 Standard Operating Procedure

446

SPC

Statistical Process Control

447

SPM

Strokes per Minute

448

SPVP

Sterile Process Validation Package

449

SSS

Sick Sinus Syndrome

450

STD

Sexually Transmitted Diseases

451

STEL

Short-Time-Exposure-Limit

452

SUPAC

Scale Up and Post Approval Changes

453

DOLPA

Super Ultra Low Penetrate Air

454

SVP

Small Volume Parenteral

455

TAMC

Total Aerobic Microbial Count

456

TC

Thermocouple

457

TCA

1 Transaction Cost Analysis

458

TDS:

Total Dissolved Solids

459

TGA

Therapeutic Goods Administration

460

THM

Trihalomnethanes

461

TM

Trace Matrix

462

TOC

 Total Oxidizable Carbon

463

TPD

Therapeutic Product Directorate

464

TPM

 Turret Per Minute

465

TPN

Total Parenteral Nutrition

466

TQM

 Total Quality Management

467

TR

Retention Time / Technical Report

468

TRIPS

Trade Related Aspects of Intellectual Property Rights

469

TS

Tensile Strength

470

TSS

Total Suspended Solids

471

TYMC

Total Yeasts and Moulds Count

472

UAD

Unidirectional Airflow Devices

473

UAT

User Acceptance Testing

474

UCL

Upper Control Limit

475

UDAF

 Unidirectional Air flow

476

UF

 Ultra-filtration

477

UFRS

User Functional Requirements Specification

478

UHF

 Ultra High Frequency

479

ULPA

Ultra Low Penetrate Air

480

UNDP

United Nations Development Programme

481

UNESCO

United Nations Educational Scientific and Cultural Organization

482

UNICEF

United Nations International Children Emergency Fund

483

UPS

Uninterrupted Power System

484

URS

User Requirements Specification

485

USAN

United States Approved Names

486

USP

United State Pharmacopoeia

487

UV

 Ultraviolet

488

V/V

 Volume-by-Volume

489

VIRUS

Vital Information Research Under Seize

490

VMP

Validation Master Plan

491

VOC

 Volatile Organic Carbons

492

W/O

Water in Oil

493

W/V

Weight by Volume

494

WBC

White Blood Cel1

495

WCB

 Working Cell Banks

496

WFI

Water for Injection

497

WHO

World Health Organization

498

WIP

Work in Progress/ Process

499

WMS

Welfare Management System

500

XE

Xenon

501

YTS

Yearly Training Schedule