GMP MANUAL

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Customer no.: NEU-1308393267345

A.3 List of Abbreviations

A

A
AAAS

American Association for the Advancement of Science

AAPS

American Association of Pharmaceutical Scientists

ABAP

Advanced Business Application Program

ABPI

Association of the British Pharmaceutical Industry

ACOS

Advisory Committee on Safety

ACPH

Air Changes Per Hour

ACS

American Chemical Society

ADE

Adverse Drug Experience

ADI

Acceptable Daily Intake

ADME

Absorption, Distribution, Metabolism and Excretion

ADR

Adverse Drug Reaction

AE

Adverse Effects (Event, Experience)

AESGP

Association Europenne des Spcialits Pharmaceutiques Grand Public (EU)

AFD

Anticipatory Failure Determination

AIBS

American Institute of Biological Science

AIM

Active Ingredient Manufacturer

AIM

Aide Mmoire

AIP

Abbreviated Inspection Program

AIP

Application Integrity Policy

AISI

American Iron and Steel Institute

ALARA

As Low As Reasonably Achievable

AMA

American Medical Association

AMC

Airborne Molecular Contamination

AMD

Analytical Method Development

AMPAC

Analytical Methods Post-Approval Changes (FDA)

AMQ

Analytical Method Qualification

AMV

Analytical Method Validation

ANADA

Abbreviated New Animal Drug Application (FDA)

ANDA

Abbreviated New Drug Application (FDA)

ANOVA

Analysis of Variance

ANSI

American National Standards Institute

AOAC

Association of Official Analytical Chemists (US)

AOQ

Average Outgoing Quality

AP

American Patent

APA

Aseptical Processing Area

APEC

Asian-Pacific Economic Cooperation

APGI

Association de Pharmacie Galnique Industrielle (F)

AphA

American Pharmaceutical Association

API

Active Pharmaceutical Ingredient

APIC

Active Pharmaceutical Ingredients Committee

APISM

API-Starting Material

APQP

Advanced Product Quality Planning

APSTJ

Academy of Pharmaceutical Sciences and Technology, Japan

AQL

Acceptable Quality Level

AR

Annual Report

ASA

American Statistical Association

ASAP

Administrative Systems Automation Project (FDA)

ASCII

American Standards Code for Information Interchange (computer files)

ASEAN

Association of South-East Asian Nations

ASHRAE

American Society of Heating, Refrigerating and Air-Conditioning Engineers

ASME

American Society of Mechanical Engineers

ASMF

Active Substance Master File

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GMP MANUAL

ASQ

American Society for Quality

ASQC

American Society for Quality Control

ASTM

American Society for Testing and Materials

ATCC

American Type Culture Collection (microbiological test)

AUC

Area under the Curve

Customer no.: NEU-1308393267345

B
BACPAC

Bulk Actives Post-Approval Changes (FDA)

BAN

British Approved Names

BAPI

Biological Active Pharmaceutical Ingredient

BARQA

British Association of Research Quality Assurance

BAT

Best Available Techniques

BCC

Blind Carbon Copy

BCT

Bacterial Challenge Test

BDCS

Biopharmaceutic Drug Classification System

BFS

Blow-Fill-Seal

BI

Biologocial Indicator

BIO

Biotechnology Industry Organization (US)

BIPM

Bureau International des Poids et Mesures

BIRA

British Institute of Regulatory Affairs

BLA

Biologics Licence Application (FDA)

BMF

Biologics Master File

BNF

British National Formulary

BP

British Pharmacopoeia

BPC

British Pharmaceutical Codex

BPC

Bulk Pharmaceutical Chemical

BPCC

Bulk Pharmaceutical Chemicals Committee

BPE

Bulk Pharmaceutical Excipients

BPE

Business Process Excellence

BPF

Bonnes Pratiques de Fabrication

BPh

British Pharmacopoeia

BQF

British Quality Foundation

BR

Batch Record

BRR

Batch Record Review

BSC

Balanced Scorecard

BSC

Biological Safety Cabinet

BSI

British Standards Institute

BUWG

Blend Uniformity Working Group (FDA)

BWP

Biotechnology Working Party

C
CAB

Conformity Assessment Body

CAD

Computer-Aided Design

CADREAC

Collaboration Agreement between Drug Regulatory Authorities of European Union Associated Countries

CAE

Computer-Aided Engineering

CAI

Compounding Aseptic Isolator

CAM

Computer-Aided Manufacturing

CANDA

Computer-Assisted New Drug Application

CAO

Computer-Aided Office Automation

CAP

Computer-Aided Planning

CAPA

Corrective Action and Preventive Action

CAPLA

Computer-Assisted Product Licence Application

CAPRA

Canadian Association of Pharmaceutical Regulatory Affairs

CAQ

Computer-Aided Quality (-assurance, -management)

CAS

Change Approval System

CAS

Chemical Abstracts Service

CAT

Critical Assessment Team

CATT

Computer-Aided Test Tool

CBER

Center for Biologics Evaluation and Research (FDA)

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Customer no.: NEU-1308393267345

CBT

Computer-Based Training

CD

Committee Draft (ISO)

CDC

Center for Desease Control (US)

CDER

Center for Drug Evaluation and Research (FDA)

CDM

Clinical Data Management

CDP

Clinical Development Plan

CDRH

Center for Devices and Radiological Health (FDA)

CE

Commission Europenne

CEC

Commission of the European Communities (EC)

CEFIC

Conseil Europen des Fdrations de lIndustrie Chimique

(European Chemical Industries Council)

CEN

Comit Europen de Normalisation

CENELEC

Comit Europen de Normalisation Electro-technique

CEO

Chief Executive Officer

CEP

Certification of Suitability of European Pharmacopeia Monographs

CETA

Controlled Environment Testing Association

CFR

Code of Federal Regulations

CFSAN

Center for Food Safety and Applied Nutrition (FDA)

CFU

Colony Forming Units

CFU

Control Functional Unit

cGMP

current Good Manufacturing Practice

cGMPR

current Good Manufacturing Practice Regulation

CHMP

Committee for Medicinal Products for Human Use

CIA

Chemical Industries Association Ltd (GB)

CID

CTFA Cosmetic Ingredient Dictionary

CIM

Computer Integrated Manufacturing

CIP

Cleaning-In-Place

CIP

Continuous Improvement Process

CIPM

Comit International des Poids et Mesures

CIR

Cosmetic Ingredient Review

CISA

Committee on International Scientific Affairs (US)

CMC

Chemistry, Manufacturing and Controls (FDA)

CMCCC

CMC Coordinating Committee (CDER)

CML

Calibration Master List

CMO

Contract Manufacturing Organization

CMS

Change Management System

CMS

Content Management System

CNC

Computerized Numerical Control

COA

Certificate of Analysis

Cod Franc

Codex Franais

COE

Code of Ethics

COMIS

Center wide Oracle Management Information System (FDA)

COP

Cleaning-out-of-Place

COS

Certificate of Suitability (inofficial: EDQM; official CEP)

COTS

Computer-off-the-Shelf

CPACT

Center for Process Analytics and Control Technology

CPD

Chemical Pharmaceutical Documentation

CPGM

Compliance Program Guidance Manual (FDA)

CPMP

Committee for Proprietary Medicinal Products (EMEA)

CPP

Certificate of Pharmaceutical Product

CPSC

Consumer Product Safety Commission (US)

CQA

Critical Quality Attribute

CRA

Clinical Research Associate

CRADA

Cooperative Research and Development Agreement (with NIH)

CRC

Child Resistant Closure

CRF

Case Report Form

CRM

Clinical Research Monitor

CRM

Customer Relationship Management

CRO

Contract Research Organization

CRS

Controlled Release Society (US)

CS

Clean Steam

Maas & Peither AG

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CS

Computer System

CSA

Canadian Standards Association

CSDD

Center for the Study of Drug Development

CSO

Consumer Safety Officer (FDA)

CSP

Compounded Sterile Preparation

CSV

Computer System Validation

CSVC

Computer System Validation Committee (of the PhRMA)

CTD

Common Technical Document

CTFA

The Cosmetic, Toiletry and Fragrance Association

CTX

Clinical Trial Exemption

CV

Computer Validation

CVM

Center of Veterinary Medicine (FDA)

CVMP

Committee for Veterinary Medicinal Products (EU)

CWQC

Company-Wide Quality Control

Customer no.: NEU-1308393267345

D
DCS

Distributed Control Systems

DDMAC

Division of Drug Marketing, Advertising and Communications (FDA)

DEMOC

Determining and Managing of Conditions

DG III

Directorate-General III

DHHS

Department of Health and Human Services (US)

DHSS

Department of Health and Social Security

DIA

Drug Information Association

DIN

Deutsches Institut fr Normung (German Institute for Standardization)

DIP

Drying in Place

DIS

Draft International Standard (ISO)

DMAIC

Define Measure Analyze Improve Control

DMF

Drug Master File (Type I processes, Type II facilities and equipment)

DMPQ

Division of Manufacturing and Product Quality (FDA)

DMS

Document Management System

DOC

Dissolved Organic Carbon

DOE

Design of Experiments

DQ

Design Qualification

DRA

Drug Regulatory Authorities

DS

Drug Substance

DS

Design Specification

DSI

Division of Scientific Investigation (FDA)

DSNP

Development of Standardized Nomenclature Project (FDA)

DTC

Direct to Consumer

DTD

Document Type Definition (for electronic interchange)

E
E.P.

English patent

EA

Environmental Assessment

EA

European Cooperation for Accreditation

EAL

European Cooperation for Accreditation of Laboratories

EAPB

European Association of Pharma Biotechnology

EBR

Electronic Batch Record

EBRS

Electronic Batch Recording System

EBSA

European Biosafety Association

EC

European Commission

EC

European Community

ECA

European Compliance Academy

ECCC

European Community Chemistry Committee (EC)

ECCLS

European Committee for Clinical Laboratory Standards

ECETOC

European Chemical Industry Ecology and Toxicology Center

ECL

Exposure Control Limit

ECPHIN

European Community Pharmaceutical Products Information Network

EDI

Electronic Data Interchange

Maas & Peither AG

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Customer no.: NEU-1308393267345

EDM

Engineering Data Management

EDMF

European Drug Master File

EDMS

Eletronic Data Management System

EDQM

European Directorate for the Quality of Medicines

EEA

European Economic Association

EEC

European Economic Community (EC)

EFA

European Food Authority

EFCG

European Fine Chemical Group

EFPIA

European Federation of Pharmaceutical Industries` Association

EFQM

European Foundation for Quality Management

EFTA

European Free Trade Association

EGA

European Generic Medicines Association

EHC

Environmental Health Criteria

EHEDG

European Hygienic Equipment Design Group

EHPM

European Federation of Health Product Manufacturers` Association

EINECS

European Inventory of Existing Chemical Substances

EIR

Establishment Inspection Report (US-FDA)

ELA

Establishment License Application (FDA, Biologics)

ELV

Exposure Limit Value

EMAS

European Eco Management and Audit Scheme

EMEA

European Medicines Evaluation Agency (European Agency for the Evaluation of Medicinal Products)

EMS

Enviromental Management System

EN

European Norm

EOL

Exchange of Letters (FDA)

EOQ

European Organization for Quality

EOTC

European Organization for Testing and Certification

EP

European Parliament

EP

European Patent

EP

European Pharmacopoeia

EPA

Environmental Protection Agency (US)

EPAR

European Public Assessment Report

EPO

European Patent Office

EQA

European Quality Award

EQS

Environmental Quality Standards

ER

Electronic Record

ERES

Electronic Records, Electronic Signature

ERP

Enterprise Resource Planning

ES

Electronic Signature

ESCOP

European Scientific Cooperative for Phytotherapy

ESRA

European Society of Regulatory Affairs

ESTRI

Electronic Standards for Transmission of Regulatory Information

ETA

Event Tree Analysis

EU

European Union

EUCOMED

European Confederation of Medical Device Manufacturers Associations

EUFEPS

European Federation for Pharmaceutical Sciences

EUGMP

European Union Good Manufacturing Practice

EUROPAMA

European Packaging Machinery Manufacturers Association

EWG

Expert Working Group (ICH)

EWP

Efficacy working party

F
FAO

Food and Agriculture Organization (UN)

FAQ

Frequently Asked Questions

FAT

Factory Acceptance Test

FCA

Field Corrective Action

FCC

Food and Chemical Codex

FCCSET

Federal Coordinating Council for Science, Engineering and Technology

FCI

Food and Chemical Index

FD&C Act

(US) Food, Drug and Cosmetic Act

FDA

Food and Drug Administration (US)

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Customer no.: NEU-1308393267345

FDAMA

Food and Drug Administration Modernization Act

FDIS

Final Draft International Standard (ISO)

FDS

Functional Design Specification

FEFO

First Expired-First Out

FEM

Federation Europeenne de la Manutention

FFDCA

Federal Food, Drug and Cosmetic Act (FDA)

FI

Failure Investigation

FICI

Federation of Irish Chemical Industries (Ei)

FIFO

First In-First Out

FIP

Fderation Internationale Pharmaceutique

FIR

Failure Investigation Report

FMEA

Failure Mode and Effect Analysis

FMECA

Failure Mode Effects and Criticality Analysis

FOI

Freedom of Information

FOIA

Freedom of Information Act (US)

FPAP

First Party Audit Program (US-FDA)

FPMAJ

Federation of Pharmaceutical Manufacturers` Association of Japan

FR

Federal Register

FS

Functional Specification

FS

Feasibility Study

FTA

Fault Tree Analysis

FTC

Federal Trade Commission (US)

G
GACP

Good Agriculturing and Collection Practice

GALP

Good Automated Laboratory Practices (EPA)

GAMP

Good Automated Manufacturing Practice (ISPE)

GAP-ML

Good Analytical Practise in Medicinal Laboratories

GATT

General Agreement on Tariffs and Trade

GCLP

Good Control Laboratory Practice

GCP

Good Clinical Practice

GCS

Good Common Sense

GCVP

Good Computer Validation Practice

GDP

Good Distribution Practice

GEP

Good Engineering Practice

GERM

Good Electronic Records Management

GGP

Good Guidance Practice (FDA)

GLP

Good Laboratory Practice

GMO

Genetically Modified Organisms

GMP

Good Manufacturing Practice

GPG

Good Practice Guide

GPHF

German Pharma Health Fund

GPIA

Generic Pharmaceutical Industry Association (US)

GRAS

Generally Recognized as Safe

GRASE

Generally Recognized as Safe and Effective

GRP

Good Review Practice

GSP

Good Storage Practice

GSP

Good Scientific Practice

GTDP

Good Trade and Distribution Practice

GTP

Good Transportation Practice

GUM

Guide to the Expression of Uncertainty in Measurement

GWQAP

Government-Wide Quality Assurance Program

GxP

Good x" Practice,

x": Clinical, Distribution, Engineering, Guidance, Laboratory, Manufacturing, Review, Scientific, Storage or
Transportation

H
HACCP

Hazard Analysis and Critical Control Points

HAT

Hardware Acceptance Testing

HAZOP

Hazard and Operability

Maas & Peither AG

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HCFA

Health Care Financing Administration (US)

HDGMP

Human Drug GMP Notes (US-FDA)

HDS

Hardware Design Specification

HEPA-Filter

(High Efficency Particulate Air)-Filter

HIMA

Health Industry Manufacturers Association

HTML

Hypertext Markup Language (IT)

HPB

Health Protection Bureau (Canada)

HPW

Highly Purified Water

HTS

High-Throughput Screening

HVAC

Heating, Ventilation and Air-Conditioning

Customer no.: NEU-1308393267345

I
I/O

Input/Output

IAAR

Independent Association of Accredited Registrars (US)

IAMS

Instrument Asset Management Team

IAQ

International Academy for Quality

IASG

International Automotive Sector Group

IB

Investigator`s Brochure

ICC

International Chamber of Commerce

ICDRA

International Conference of Drug Regulatory Authorities

ICH

International Conference on Harmonization

ICSC

International Chemical Safety Cards

IDE

Investigational Device Exemption (FDA)

IEC

International Electrotechnical Commission

IEEE

Institute for Electrical and Electronics Engineers

IFPMA

International Federation of Pharmaceutical Manufacturers Association

IGPA

International Generic Pharmaceutical Alliance

ILAC

International Laboratory Accreditation Cooperation

IMB

Irish Medicines Board

IMP

Investigational Medicinal Product

IMPD

Investigational Medicinal Product Dossier

IMS

Integrated Management System

INA

Information Not Available

IND

Investigational New Drug

INDA

Investigational New Drug Application (FDA)

INDC

Investigational New Drug Committee (FDA)

INN

International Nonproprietary Names

IOM

Inspections Operations Manual

IPC

In-Process-Control

IPCS

International Programme on Chemical Safety

IPEC

International Pharmaceutical Excipients Council

IPRD

International Product Registration Document

IPRO

Independent Pharmaceutical Research Organization

IQ

Installation Qualification

IQA

International Quality Assurance

IRB

Institutional Review Board (FDA)

IRD

International Registration Document

IRIS

Integrated Risk Information System

IRS

Identical, Related or Similar

ISA

Instrumentation, Systems and Automation Society

ISE

Integrated Summaries of Efficacy

ISDN

Integrated Services Digital Network

ISO

International Standards Organization

ISPE

International Society for Pharmaceutical Engineering

ISSS

Information Society Standardization System

IT

InformationTechnology

ITCC

Information Technology Coordinating Committee (CDER)

ITIL

Information Technology Infrastructure Library

IVD

In Vitro Diagnostics

IVIVC

In Vitro In Vivo Correlation

Maas & Peither AG

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Customer no.: NEU-1308393267345

J
JAN

Japanese Accepted Names

Japan. P.

Japanese Patent

JCGM

Joint Committee for Guides in Metrology

JETT

Joint Equipment Transition Team

JIT

Just in Time

JNIH

Japan National Institute of Health

JP

Japanese Pharmacopoeia

JPMA

Japan Pharmaceutical Manufacturers Association

JSG

Joint Sectoral Group

JUSE

Japanese Union of Scientists and Engineers

K
KPI

Key Performance Indicator

L
LAN

Local Area Network

LAFW

Laminar Airflow Workbench

LF

Laminar Flow

LIMS

Laboratory Information Management System

LIR

Laboratory Investigation Report

LOC

Level of Concern

LOD

Limit of Detection

LOEL

Lowest Observable (Observed) Effect Level

LOQ

Limit of Quantitation

LRV

Logarithmic Reduction Value

LVP

Large Volume Parenteral

M
MA

Marketing Authorization

MAA

Marketing Authorization Application

MACO

Maximum Acceptable Carry-Over

MAIL

Medicines Act Information Letter

MAL

Medicines Act Leaflets

MaPPS

Manual of Policies and Procedures (FDA)

MBC

Minimum Bactericidal Concentration

MBO

Management by Objectives

MBR

Master Batch Record

MCA

Medicines Control Agency (UK)

MCB

Master Cell Bank

MDA

Medical Devices Agency (UK)

MDD

Medical Device Directives (EU)

MDR

Medical Device Report

Med DRA

Medical Dictionary for Regulatory Activities

MEP

Member of the European Parliament

MES

Manufacturing Execution System

MF

Microfiltration or Microfilter

MHLW

Ministry of Health, Labour and Welfare Koseisho" (Japan)

MIC

Minimum Inhibitory Concentration

MJA

Mutual Joint Audit (EU)

MJV

Mutual Joint Visit (EU)

MMP

Microbiological Monitoring Programme

MOA

Memoranda of Agreement (FDA)

MOC

Memoranda of Cooperation (FDA)

MOH

Ministry of Health

MOU

Memoranda of Unterstanding (FDA)

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GMP MANUAL

MPI

Master Production Instruction

MRA

Mutual Recognition Agreement

MRFG

Mutual Recognition Facilitation Group

MSC

Manufacturing Scorecard

MSDS

Material Safety Data Sheet

MSSO

Management Support and Services Organization (ICH)

MTBF

Mean Time Between Failure

MTD

Maximum Tolerated Dose

MTTF

Mean Time to Failure

Customer no.: NEU-1308393267345

N
NACCB

National Accreditation Council for Certification Bodies

NADA

New Animal Drug Application

NAI

No Action Indicated (FDA)

NAMAS

National Measurement Accreditation Service

NAPM

National Association of Pharmaceutical Manufacturers (US)

NAS

New Active Substance

NATRIC

National Reporting and Investigation Centre

NBE

New Biological Entity

NBS

National Bureau of Standards

NCE

New Chemical Entity

NCTC

National Collection of Type Cultures (UK)

NDA

New Drug Application

NDE

New Drug Evaluation (FDA)

NDMA

Nonprescription Drug Manufacturers Association

NDS

New Drug Study

NEL

No Effect Level

NF

National Formulary

NF

Nanofiltration or Nanofilter

NFG

Note for Guidance (CPMP)

NHS

National Health Service

NHW

National Health and Welfare Department (Canada)

NIBSC

National Institute for Biological Standards and Control (UK)

NIH

National Institute of Health

NIOSH

National Institute for Occupational Safety and Health (US)

NIST

National Institute for Standards and Technology (US)

NME

New Molecular Entity

NND

New and Nonofficial Drugs

NNR

New and Nonofficial Remedies

NOEL

No Observed Effect Level

NPA

National Pharmaceutical Alliance (US)

NRC

National Research Council (US)

NSF

National Sanitation Foundation (US)

NSR

Nonsignificant Risk

NTIS

National Technical Information Service (US)

O
OAI

Official Action Indicated

ODE

Office of Drug Evaluation (FDA)

OECD

Organization for Economic Cooperation and Development

OEE

Overall Equipment Efficiency

OEL

Occupational Exposure Limit

OEM

Original Equipment Manufacturer

OLE

Object Linking and Embedding

OMCL

Official Medicinal Control Laboratories

OMO

Office of Management and Operations (FDA)

ONDC

Office of New Drug Chemistry (CDER)

ONDQA

Office of New Drug Quality Assessment (FDA)

OOS

Out of Specification (-Result)

Maas & Peither AG

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OPC

OLE for Process Control

OPCD

Optimized Preclinical Development

OPS

Office of Pharmaceutical Science (CDER)

OQ

Operational Qualification

ORA

Office of Regulatory Affairs (FDA)

OS

Operating System

OSAT

On-Site Acceptance Test

OSHA

Occupational Safety and Health Administration (US)

OSHA

On-Site Hazard Analysis

OTC

Over-the-Counter

Customer no.: NEU-1308393267345

P
P & ID

Piping and Instrument Diagram (see RI)

PA

Pre-Approval (US-FDA)

PAA

Premarket Approval Application

PAB

Pharmaceutical Affairs Bureau

PAC-ATLS

Post-Approval Changes Analytical Testing Laboratory Sites (FDA)

PACPAC

Packaging Post Approval Changes (FDA)

PAC-SAS

Post-Approval Changes for Sterile Aqueous Solutions (FDA)

PAD

Pharmacological Active Dose

PAI

Pre-Approval Inspection

PAITS

Pre-Approval Inspection Tracking System (FDA)

PAR

Proven Acceptable Range (Process Validation)

PAS

Prior Approval Supplement (SUPAC)

PAT

Preliminary Acceptance Test

PAT

Process Analytical Technology (FDA)

PBR

Production Batch Record

PC

Programming Committee (ISO)

PCA

Principal Component Analysis

PCS

Process Control System

PDA

Parenteral Drug Association (US)

PDE

Permitted Daily Exposure

PDF

Portable Document Format

PDG

Pharmacopeial Discussion Group

PDR

Physicians` Desk Reference

PDUFA

Prescription Drug User Fee Act (US)

PERF

Pan European Regulatory Forum

PFD

Process Flow Diagram

Ph Eur

Pharmacopoeia Europaea

PhRMA

Pharmaceutical Research and Manufacturing Association (US)

PHS

Public Health Service (US)

PHSA

Public Health Service Act (FDA)

PhVWP

Pharmacovigilance Working Party

PIC

Pharmaceutical Inspection Convention

PIC/S

Pharmaceutical Inspection Cooperation Scheme

PICSVF

Pharmaceutical Industry Computer Systems Validation Forum (UK)

PID

Process and Instrument Diagram

PIP

Product Improvement Program

PL

Product License

PLA

Product License Application

PLC

Programmable Logic Controller

PLI

Pre-License Inspection (FDA)

PLM

Product Lifecycle Management

PM

Project Manager

PMA

Pharmaceutical Manufacturers Association (currently: PhRMA)

PMA

Premarket Approval Application

PMDA

Pharmaceuticals and Medical Devices Agency (Japan)

PMF

Plant Master File

PMS

Postmarketing Surveillance

PNDS

Preclinical New Drug Submission

Maas & Peither AG

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PPI

Patient Package Insert

PQ

Performance Qualification

PQG

Pharmaceutical Quality Group (UK)

PQLI

Product-Quality-Liefecycle-Implementation

PQRI

Product Quality Research Institute (US)

PR

Public Relations

PSJ

Pharmaceutical Society of Japan

PSUR

Periodic Safety Update Report

PTO

Patent and Trademark Office (US)

PTPP

Pharmaceutical Target Product Profile

PV

Process Validation

PW

Purified Water

Customer no.: NEU-1308393267345

Q
QA

Quality Assurance

QA/RA

Quality Assurance and Regulatory Affairs

QAC

Quality Acceptance Criteria

QAM

Quality Assurance Manual

QAU

Quality Assurance Unit

QBD

Quality by Design

QbD

Quality by Design

QC

Quality Control

QC

Quality Circle

QCA

Quality Correlation Analysis

QCU

Quality Control Unit

QE

Quality Engineering

QFD

Quality Function Deployment

QHD

Qualified Hygienic Design

QM

Quality Management

QMP

Qualification Master Plan

QMS

Quality Management System

QP

Qualified Person

QRD

Quality Review of Documents (EMEA)

QRM

Quality Risk Management

QSIT

Quality System Inspection Technique (FDA)

QSR

Quality Systems Regulation (US-FDA)

QU

Quality Unit

QUAL

Qualification

QWP

Quality Working Party

R
R&D

Research and Development

RA

Regulatory Affairs

RABC

Risk Analysis and Biocontamination Control

RABS

Restricted Access Barrier System

RAPS

Regulatory Affairs Professionals Society (US)

RARM

Risk Assessment Risk Management

RAS

Rapid Alert System (EU)

RBA

Risk Based Approach

RC

Responsible Care

RCM

Reliability Centered Maintenance

REACH

Registration, Evaluation, Authorisation and restriction of Chemicals

rDNA

ribosomal DNA

RFID

Radio Frequency Identification

RH

Relative Humidity

Risk MAP

Risk Minimization Action Plan (FDA)

RL

Regulatory Letter (FDA)

RLU

Relative Light Units

RM

Risk Management

Maas & Peither AG

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RMM

Rapid Microbiological Methods

RMS

Reference Member States

RMS

Regulatory Management System (FDA)

RPN

Risk Priority Number

RTP

Rapid Transfer Port

RTR

Real Time Release

RTU

Ready to Use

Customer no.: NEU-1308393267345

S
SAG.E

Senior Advisory Group - Environment (CEFIC)

SAG.T

Senior Advisory Group - Trade (CEFIC)

SAGE

Strategic Advisory Group on Environment

SAL

Sterility Assurance Level

SAT

Site Acceptance Test

SAWG

Scientific Advice Working Group (EMEA)

SBA

Summary Basis of Approval

SCA

Supplier Corrective Action

SCADA

Supervisory, Control and Data Acquisition

SCM

Supply Chain Management

SD

Standard Deviation

SDLC

Systems Development Life Cycle

SDLC

Software Development Life Cycle

SDS

Safety Data Sheet

SDS

Software Design Specification

SE

Standard Error

SELS

Surface Evaluation of Living Skin

SEMI

Semiconductor Equipment and Materials International

SG

Sector Group (CEFIC)

SIL

Safety Integrity Levels

SIP

Sterilization-In-Place

SLA

Service Level Agreement

SMART

Submission Management and Review Tracking (FDA)

SMART

Selfmonitoring and Report Technology

SMF

Site Master File

SMO

Site Management Organization

SmPC

Summary of Product Characteristics

SNDA

Supplemental New Drug Application (FDA)

SOP

Standard Operating Procedure

SPC

Statistical Process Control

SPC

Summary of Product Characteristics

SQ

Specification Qualification

SQL

Structured Query Language

SRM

Standard Reference Material

STT

Short Term Tests

SUPAC
(IR, MR, SS)

Scale-Up and Post-Approval Changes (FDA), (immediate release solid oral dosage forms; modified release;
semisolid dosage forms)

SVP

Small Volume Parenteral

SWOT

Strengths, Weaknesses, Opportunities, Threats

SWP

Safety Working Party

T
TABD

Trans-Atlantic Business Dialogue

TASC

Technical Affairs Steering Committee (ISO)

TC

Technical Committee (ISO)

TCO

Total-Cost-of-Ownership

TDI

Tolerable Daily Intake

TDS

Total Dissolved Solids

TEP

Tender Evaluation Panel (ICH)

TGA

(Australian) Therapeutic Goods Administration

Maas & Peither AG

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2011-06-20

GMP MANUAL

Printed by: Pharma Access

TIA

Totally Integrated Automation

TM

Test Method

TOC

Total Organic Carbon

TOC

Table of Contents

TPM

Total Productive Maintenance

TPM

Third Party Manufacturer

TQD

Total Quality Deployment

TQM

Total Quality Management

TSE

Transmissible Spongiforme Enzephalopathy

TWA

Time Weighted Average

Customer no.: NEU-1308393267345

U
UF

Ultrafiltration

UMDNS

Universal Medical Device Nomenclature System

UN

United Nations

UNESCO

United Nations Educational Science and Cultural Organization

UNICE

Union of Industries of the European Community

URS

User Requirement Specification

USC

United States Code (book of laws)

USDA

United States Department of Agriculture

USEPA

United States Environmental Protection Agency

USN

U.S. Adopted Names

USP

Unique Selling Proposition

USP

United States Pharmacopeia

USP-DI

United States Pharmacopoeia-Drug Information

USP-NF

United States Pharmacopoeia-National Formulary

V
VAI

Voluntary Action Indicated (FDA)

VAL

Validation

VC

Visibly Clean
Visually Clean

VHP

Vaporised Hydrogen Peroxide

VMP

Validation Master Plan

VOC

Volatile Organic Compounds

VP

Validation Plan

VR

Validation Report

W
WBT

Web Based Training

WCB

Working Cell Bank

WELMEC

Western European Legal Metrology Cooperation

WFI

Water for Injection

WHO

World Health Organization

WIP

Washing-In-Place

WL

Warning Letter (FDA)

WNL

Within Normal Limits

WTO

World Trade Organization

Maas & Peither AG

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2011-06-20