GMP Encyclopedia

Glossary, Acronyms and General words for Pharmaceutical Industry

Version: 00, Date: March 7, 2019


Glossary, Acronyms and General words are collected and collated from WHO, EU GMP, ISO14644, ISPE, FDA, ICH, PIC/S. And will be updated periodically by Foshan RuiTong Consulting Co.,Ltd.

Table of Contents

1.  Glossary.PAGEREF _Toc2853244 \h3

2.  Abbreviations & acronyms.PAGEREF _Toc2853245 \h34

3.  General words for water system..PAGEREF _Toc2853246 \h39

4.  General words for QC Laboratory.PAGEREF _Toc2853247 \h41

5.  General words for HVAC system  PAGEREF _Toc2853248 \h44

1.  Glossary

           Omitted due to limited website capacity, if need more contents, please contact us.

2.  Abbreviations & acronyms

ACPH: Air changes per hour

ADR: Adverse drug reaction

AHU: Air-handling unit

API: Active pharmaceutical ingredient

APIMF: Active pharmaceutical ingredient master file

ATCC: American Type culture collection

ARV: Antiretroviral

BAS: Building automation system

BI: Biological indicator

BCS: Biopharmaceutics Classification System

BFS: Blow-fill-seal system

BMGF: Bill & Melinda Gates Foundation

BMS: Building management system

BSL: Biosafety level

CAPA: Corrective and preventive action

CDER: Center for drug evaluation and research

CFU: Colony forming unit

CIP: Clean in place

CMC: Chemistry, manufacturing and control

COA: Certificate of Analysis

COD: Chemical oxygen demand

CP: Compliance program

CPP: Critical process parameter

CPU: Central processing unit

CQA: Critical quality attribute

CRO: Contract research organization

CROMF: Contract research organization master file

CRS: Chemical reference substance

CTD: Common technical document

C&Q:Commissioning & qualification

DAD: Diode-Array Detector

DCS: Distributed control system

DDS: Detailed design specification

DEC: Diethylcarbamazine

DI: Deionized water

DMF: Drug master file

DNDi: Drugs for Neglected Diseases initiative

DQ: Design qualification

DS: Design specification

E.Coli: Escherichia Coli

eCTD: Electronic common technical document

EDI: Electro-deionization

EDQM: European Directorate for the Quality of Medicines

EIR: Establishment Inspection Reports

EMS: Environmental Monitoring System

EOI: Invitation to Manufacturers to Submit an Expression of Interest for Product Evaluation

EP:European pharmacopoeia

EPDM: Ethylene-propylene-diene monomer

ERP: Enterprise resource planning

EU: European Union

FAT: Factory acceptance test

FDC: Fixed-dose combination

FDA: Food and drug administration

FDS: Functional design specification

FIFO: First in First out

FMEA: Failure mode and effects analysis

FPP: Finished pharmaceutical product

FS: Functional specification

GAMP: Good automated manufacturing practice

GCP: Good clinical practices

GDP: Good distribution practice

GEP: Good engineering practice

Global Fund: Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria

GLP: Good laboratory practices

GMO: Genetically modified organism

GMP: Good manufacturing practice

GPS: Global positioning system

GXP: Acronym for the group of good practice guides governing the preclinical, clinical, manufacturing, testing, storage, distribution and post-market activities for regulated pharmaceuticals, biologicals and medical devices, such as good laboratory practices, good clinical practices, good manufacturing practices, good pharmacovigilance practices and good distribution practices.

HACCP: Hazard analysis and critical control points

HBV: Hepatitis B virus

HCV: Hepatitis C virus

HDD: Hardware disk drive

HDPE: High density polyethylene

HIV/AIDS: Human immunodeficiency virus/acquired immune deficiency syndrome

HEPA: High-efficiency particulate air

HMI: Human-Machine interface

HPLC: High pressure liquid chromatography

HSE: Health, safety and environment

HVAC: Heating, ventilation and air-conditioning

I/O: Input/output

I/O Port: Input/outpu connector

IBC: Intermediate bulk container

ICH: International conference on harmonization

ICRS: International chemical reference substance

ID: Identification/Identity

IP: International Pharmacopoeia

IQ: Installation qualification

IND: Investigational new drug

INN: International nonproprietary names

In vivo: Testing conducted in living animal and human systems

In vitro: Non-clinical testing conducted in an artificial environment such as a test tube or culture medium.

IR: Infrared

ISO: International standards organization

ISPE: International society for pharmaceutical engineering

IT: Information technology

IUPAC: International Union of Pure and Applied Chemistry

JP: Japanese Pharmacopoeia

KPI: Key performance indicator

LAF: Laminar air flow

LC/MS: Liquid chromatography/mass spectrometer

LC50: Lethal concentration-50%

LD50: Lethal dose-50%

LDPE: Low density polyethylene

LEL: Lower explosive limit

LFL: Lower flammability level

LIF: Laboratory information file

LIMS: Laboratory information management system

LVP: Large volume parenteral (more than 100ml)

LYO: Lyophilizer (freeze dryer)

MAH: Marketing authorization holder

MCB: Master cell bank

MSDS: Material safety data sheet

MWCB: Manufacturers working cell bank

NDA: New drug application

NF: National formulary

NMRA: National medicines regulatory agency

OD: Outside diameter

OEL: Occupational exposure limits

OOS: Out of specification

OSD: Oral solid dosage

OTC: Over the counter

OQ: Operational qualification

RABS: Restricted access barrier system

RO: Reverse osmosis

PAD: Pulsed amperometric detection (in HPLC)

PAT: Process analytical technology

PDE: Permitted daily exposure

PE: Polyethlene

PFD: Process flow diagram

PIC/S: The pharmaceutical inspection co-operation scheme

PK: Pharmacokinetics

PM: Preventive maintenance

PQ: Performance qualification

PQTm: Prequalification Team (of the World Health Organization)

PIL: Patient information leaflet

PLC: Programmable logic controller

PTFE: Polytetrafluoroethylene (Teflon)

PVC: Polyvinyl chloride

PVDC: Polyvinylidene chloride

PVDF: Polyvinylidene fluoride

PW: Purified water

P&ID: Process/Piping and instrumentation diagram or drawing

QbD: Quality by design

QC: Quality control

QCL: Quality control laboratory

R&D: Research and development

RH: Relative humidity

RO: Reverse osmosis

SAT: Site acceptance test

SCADA: System control and data acquisition system

SDS: Software design specification

SEM: Scanning electron microscopy

SIP: Steam sterilize in place

SME: Subject matter expert

SMF: Site master file

SOP: Standard operating practice

SRA: Stringent regulatory authority

SVT: Small volume parenteral (less than 100ml that are terminally sterilized)

SVS: Small volume parenteral are sterilized by filtration and aseptically processed.

SVL: Small volume parenteral are sterilized by filtration, aseptically filled and lyophilized.

SLQ: Sterile liquid (other than suspensions and emulsions)

SON: Sterile ointment

SPW: Sterile powder

CSN: Non sterile API by chemical synthesis

CSS: Sterile bulk drugs that are made by chemical synthesis

CFS: Sterile crude drugs (API) made by fermentation

TB: Tuberculosis

TGA: Therapeutic Goods Administration (Australia)

TLC: Thin-Layer Chromatography

TOC: Total organic carbon

TSE: Transmissible spongiform encephalopathy

UDAF: Unidirectional airflow

UF: Ultra filtration

UPS: Uninterruptible power supply

UPW: Ultrapure water

USP: United states pharmacopoeia

USAN: United states adopted names

URS: User requirements specification

US: United states

USB: Universal serial bus

UV: Ultraviolet Light

VMP: Validation master plan

VOC: Volatile organic compound

WCB: Working cell bank

WFI: Water for injection

WHO: World Health Organization

WHOPAR: WHO Public Assessment Report

WHOPIR: WHO Public Inspection Report

WO: Work Order

WPU: Water for pharmaceutical use

XRPD: X-Ray Powder Diffraction

3.  General words for water system

-       Drinking water

-       Feed water

-       Raw water

-       Purified water (PW)

-       Water for injection (WFI)

-       Reverse osmosis (RO)

-       Electro-deionization (EDI)

-       Vapour compression (VC)

-       Ultrafiltration

-       Deionization

-       Heating steam

-       Chilled water

-       Compressed air

-       Sewage system

-       Exhaust air

-       Sanitization strategy

-       Water-treatment equipment

-       Water purification equipment, storage and distribution systems

-       Hygienic or sanitary design

-       Corrosion resistance

-       Freedom from leakage

-       Configuration

-       Proliferation

-       Desalinization

-       Ion exchange

-       Filtration

-       Softening

-       Disinfection

-       Sanitization

-       Iron removal

-       Precipitation

-       Downstream treatment stages

-       Upstream treatment stages

-       Distribution pipework

-       Flush

-       Sanitize

-       Prevented vents

-       Microbiological contamination

-       Ultraviolet disinfection

-       Thermal sanitization

-       Stainless steel (at least grade 316)

-       Roughness (average surface roughness, not greater than 0.8 micrometre (RA)

-       Crevices

-       Electro-polishing techniques

-       Proportion of welds (e.g.: 100% hand welds, 10% automatic welds)

-       Flange, union and valves

-       Diaphragms

-       Material certificates

-       Polypropylene

-       Polyvinylidene-difluoride

-       Perfluoroalkoxy

-       Spray ball

-       Headspace

-       Droplets

-       Nozzles

-       Vent filter

-       Storage tank

-       Distribution loop

-       Stand-by pump (avoid dead zones)

-       Stagnant water

-       Turbulent flow circulation

-       Biofilm

-       Deadlegs (not exceed 3times the branch diameter, 3D)

-       Pressure gauges

-       Membrane

-       Hygienic pattern diaphragm valves

-       Slope

-       Drainable

-       PQ Phase 1, 2weeks, phase 2, 2 weeks, phase 3, one year.

-       Continuous system monitoring

-       Log books

-       P&ID: piping and instrumentation diagram or drawing

4.  General words for QC Laboratory

-       Characteristics

-       Accuracy

-       Precision

n  Repeatability (precision under the same operating conditions over a short period of time)

n  Intermediate precision (within one laboratory, different dates, different analyst or different instruments)

n  Reproducibility (precision between laboratories)

-       Specificity

-       Detection limit

-       Quantitation limit

-       Linearity

-       Range

-       Pharmacopoeia methods

-       Garment

-       Top-loading balance

-       Analytical balance (5 digits)

-       Melting-point apparatus

-       pH meter (with assorted electrodes)

-       microscope

-       polarimeter

-       high-performance liquid chromatograph with ultraviolet detector

-       ultraviolet/visible spectrophotometer

-       infrared spectrophotometer with pellet press

-       Karl Fischer titrator (semi-micro determination of water)

-       Agate mortar with pestle

-       Equipment for thin-layer chromatography

-       Thin-layer chromatography spotter

-       Developing chambers

-       Atomizers

-       Ultraviolet viewing lamp

-       Potentiometric titrimeter

-       Micro-Kjeldahl equipment (including fume flasks)

-       Disintegration test equipment (1 basket for 6 tablets)

-       Dissolution apparatus

-       Soxhlet extraction apparatus (60ml)

-       Micrometer calipers

-       Pycnometer

-       Burette /pipettes (10ml and 25ml/1,2,5,10,20, 25, 50ml)

-       Heating mantles for flasks (assorted sizes: 50, 200 and 2000ml)

-       Sieves (assorted sizes)

-       Desiccator

-       Centrifuge (table-top model, 4-place swing rotor)

-       Centrifuge (floor model)

-       Water-batch (20 litres)

-       Hot plates with magnetic stirrers

-       Vacuum pump (rotary, oil)

-       Vacuum rotary evaporator

-       Drying oven (60 litres)

-       Vacuum oven (17 litres)

-       Muffle furnace (23 litres)

-       Refrigerator (explosion-proof)

-       Freezer

-       Water distilling apparatus (8 litres/hour)

-       Water deionizer (10 litres/hour)

-       Dehumidifier (where needed)

-       Fume hood

-       Analytical microbalance

-       Flame photometer (including air compressor)

-       Refractometer

-       Viscometer

-       Vortex mixer

-       Shaker (wrist-action)

-       Pipette rinser

-       Constant temperature water-bath

-       Ultrasonic cleaner (5 litres)

-       Laboratory glassware washing machine

-       Gas chromatograph (flame ionization, direct and static head space injection)

-       Oxygen flask combustion apparatus

-       Atomic absorption spectrophotometer

-       Spectrofluorometer

-       High-performance liquid chromatograph detectors:

n  Fluorescence

n  Diode-array

n  Refractive index

n  Evaporative light scattering (ELSD)

n  Charged aerosol (CAD)

n  Mass spectrometric (MS)

-       Gas chromatograph detectors:

n  Conductivity

n  Nitrogen/phosphorous (NPD)

n  Mass spectrometric (MS)

-       Capillary electrophoresis equipment

-       Thin-layer chromatography scanner

-       Crushing strength tester

-       Friability tester

-       Ice machine

-       Solvent-recovery apparatus

Equipment for microbiology unit

-       pH meter

-       ultraviolet/visible spectrophotometer, single-beam

-       microscope(for bacteriology)

-       membrane filter assembly for sterility tests

-       colony counter with magnifier

-       laminar air flow unit

-       hot-air sterilizer

-       incubators, 60 litres

-       Anaerobic jar

-       Zone reader

-       Centrifuge

-       Water-bath (thermostatically controlled)

-       Autoclaves (100 litres, top-loading)

-       Refrigerators (340 litres)

-       Deep freeze

-       Laboratory glassware washing machine

-       Garment

-       Settle (exposure) plates

-       Surface contact

-       Swabs

-       Flexible film

-       Volumetric equipment (automatic dispensers, dispenser/diluter, mechanical hand pipettes, disposable pipettes)

-       Reference thermometers

-       Reference thermocouples

-       Timers

5.  General words for HVAC system

-       Airborne particles

-       Occupancy states (as-build, at-rest, operational)

-       Particle size

-       Minimum number of sampling locations to be tested (NL)

-       LSAPC, light scattering particle counter

-       Level 1, general area, e.g.: warehouse; Primary filter, G4 filters

-       Level 2, protected area, e.g.: secondary packaging, first stage change rooms, Primary plus secondary filters, G4 plus F8 or F9 filters

-       Level 3, controlled area, e.g.: area of product exposed to room environment., Primary plus secondary plus tertiary filters,  G4 plus F8 or F9 plus H13 filters.

-       Horizontal and vertical unidirectional flow

-       Ceilings

-       Walls

-       Building management system (BMS)

-       Building automation system (BAS)

-       System control and data acquisition (SCADA) system

-       Interlocking system

-       Warning system

-       Airlock

-       Air break

-       Backflow

-       Sink

-       drains

-       Fresh air

-       Return air

-       Frost coil

-       Reheater

-       Automatic air volume control devices

-       Sound attenuators

-       Snow eliminator

-       Dust eliminator

-       Air inlet

-       Moisture eliminator

-       User requirement specifications (URS)

-       Relative humidity

-       Supply air quantities for all diffusers

-       Return air or exhaust air quantities

-       Room air change rates

-       Room pressures (pressure differentials)

-       Room airflow patterns

-       Unidirectional flow velocities

-       Containment system velocities

-       HEPA filter penetration tests

-       Room particles counts

-       Room clean-up rates

-       Particle count test

-       Cleanliness

-       Filter leakage tests

-       Containment leakage

-       Recovery

-       Operating and maintenance

-       Headgear

-       Beard

-       Moustache

-       Neck

-       Face mark

-       Shedding

-       Droplets

-       Footwear

-       Garment

-       Plastic gloves

-       Working session

-       Fiber

-       Exposed surfaces

-       Accumulation of particles or micro-organisms

-       Cleaning agents

-       Disinfectant

-       Uncleanable recesses

-       Projecting ledges

-       Shelves

-       Cupboards

-       Changing rooms

-       Hand washing facilities

-       Simultaneously

-       Positive pressure

-       Flush

-       Adjacent rooms

-       Pressure differential of 10-15 pascals

-       Air-flow patterns

-       Conveyor belt

-       Pass through

-       Fumigation

-       Validated loading patterns

-       Biological indicators

-       Tray