GMP Manual

GMP MANUAL Contents

GMP MANUAL Contents

1 Pharmaceutical Quality System (PQS)

1.A Preface

1.B The road

1.C Introduct1.C.1 General re1.C.2 Documen

1.D Main elem1.D.1 Managem1.D.2 Resource 1.D.3 Manufact1.D.4 Evaluation

1.E Essential1.E.1 Principles1.E.2 Process m1.E.3 Responsib1.E.4 Key Perfo

1.F Practical 1.F.1 Assistanc1.F.2 Organizat1.F.3 Process o1.F.4 Documen

1.G Structure

1.H Correlati9001:200

1.I Referenc

2 Person

2.A Place of w

2.B Requirem2.B.1 Qualificat2.B.2 Health req

GMPIVZ-Druck.fm Seite 1 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore

Cont

ents

(1)GMP Manual (Up14) Maas & Peither AG GMP Publishing

to a Pharmaceutical Quality System

ion to the PQSquirementstation

ents of a PQSent responsibilitymanagementuring operations

activities

s of a PQS of a processappingilities

rmance Indicators (KPIs)

implementation of a PQSe for implementationional aspectsf developing documentst hierarchy

of a PQS quality manual example

on between GMP requirements (WHO) and ISO 0

es

nel

ork and job descriptions

ents of the personnelion requirementsuirements

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ents

2.C Training 2.C.1 Purpose of training2.C.2 Responsibility for training2.C.3 Requirements profiles/learning objectives2.C.4 Training contents and target groups2.C.5 Training planning2.C.6 Carrying out2.C.7 Reviewing the training and the training system2.C.8 Documentation

2.D Function2.D.1 Qualified 2.D.2 Head of P2.D.3 Head of Q2.D.4 Qualified

Article 102.D.5 Scientific 2.D.6 Medical s

3 Premis

3.A Official R3.A.1 Location, 3.A.2 Size, area3.A.3 Installatio3.A.4 Lighting, 3.A.5 Hygienic 3.A.6 Room boo

3.B Material 3.B.1 Material f3.B.2 Personne3.B.3 Layout 3.B.4 Design co

Produced

3.C Room cla3.C.1 General G3.C.2 GMP Requ3.C.3 Correspon3.C.4 GMP Requ3.C.5 Room-spe3.C.6 Cleanline3.C.7 Convertin

GMPIVZ-Druck.fm Seite 2 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing

owners subject to public law Person (QP)roductionuality ControlPerson in Accordance with 3 of Guideline 2001/83/ECService in Charge of Informationales representatives

es

equirementsconnection to other rooms , heightn and supply of utilities ventilation, air-conditioningconstruction

k and layout

flow, personnel flow and layoutlow l flow

ncepts in FDAs Sterile Drug Products by Aseptic Processing guideline

ssesMP Requirements for Premisesirements for Cleanrooms: Air Cleanliness Gradesding FDA Determinationsirements for Premisescific Allocation of Air Cleanliness Stipulations

ss Zoning Conceptsg GMP Stipulations into Reality

GMP MANUAL Contents

3.D Construction elements3.D.1 Walls 3.D.2 Doors and windows 3.D.3 Floors 3.D.4 Ceilings

3.E Barrier systems and isolators3.E.1 Protection concepts for maximized sterility assurance3.E.2 Pharmaceutical isolator technology3.E.3 Restricted3.E.4 Applicatio

3.F Building 3.F.1 Basic requ3.F.2 Heating3.F.3 Sanitary p3.F.4 Electrical 3.F.5 Qualificat

3.G Heating V3.G.1 Introduct3.G.2 Room ven3.G.3 Filters3.G.4 Principles

condition3.G.5 Design cr3.G.6 Maintena

3.H Process G3.H.1 Quality Re3.H.2 Generatio3.H.3 System de3.H.4 Qualificat

3.I Qualifica3.I.1 Objective3.I.2 Regulator3.I.3 Project de3.I.4 Qualificat3.I.5 Qualificat3.I.6 Qualificat3.I.7 Requirem3.I.8 Requalific

3.J Monitori3.J.1 Objective3.J.2 Data man3.J.3 Air cleanl


Cont

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access barrier systems (RABS technology)n options for RABS and isolators

servicesirements for installation

lumbing and sewage installations incl. IT-management and control systems ion

entilation Air Conditioning (HVAC)ion tilation systems

for the design and planning of air ing ventilation systems iteria for the ventilation of premises nce of air ventilation systems

asesquirementsn, Storage and Distributionsign

ion and monitoring

tion of premises and air-conditioning systemss of qualificationy and normative fundamentals of qualificationvelopment and qualification

ion Master Planion Plans and Qualification Reportsion checklistsents for measurement and test reportsation

ng of HVAC systemss of process monitoringagement stipulationsiness and other room air data

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3.J.4 Risks of microbiological monitoring3.J.5 Alarm and action limits3.J.6 Operation and maintenance

3.K References

4 Facilities and Equipment

4.A Introduction

4.B Mechanic4.B.1 Construct4.B.2 GMP-com4.B.3 Electrical

4.C Control

4.D Facility c4.D.1 CIP (Clean4.D.2 Isolator te4.D.3 Connecte

4.E Examples4.E.1 Design qu4.E.2 Installatio4.E.3 Operation

4.F Technica4.F.1 Necessity4.F.2 Scope and4.F.3 Administr4.F.4 Log book

4.G Calibratio4.G.1 Definition4.G.2 Procedure4.G.3 Documen4.G.4 Administr

4.H Maintena4.H.1 Types of m4.H.2 GMP-conf4.H.3 Systems f

4.I CIP (Clea4.I.1 Introduct4.I.2 CIP system4.I.3 GMP-conf4.I.4 Nozzle he


al componentsion and installation materialspliant design characteristicsand pneumatic components

onceptsing in Place)chnologyd facilities

of facility qualification,alificationn qualificational qualification

l documentation

contentation of the technical documentation

ns

tationation of scheduled calibration dates/ times

nceaintenance

orming maintenanceor maintenance

ning in Place)ion

sorming design of CIP facilitiesads for container cleaning

GMP MANUAL Contents

4.I.5 Measuring technology4.I.6 Realisation of cleaning systems

4.J Containment (personnel protection) in solids handling

4.J.1 Significance4.J.2 Definition of terms4.J.3 Containment grades of products4.J.4 Measurement of the residue limits (OEL)4.J.5 Example o4.J.6 Containm4.J.7 Containm4.J.8 Container4.J.9 Filter syst4.J.10 Sampling4.J.11 Containm

4.K Process c4.K.1 Definition4.K.2 Features o4.K.3 How to us4.K.4 Carrying o4.K.5 Qualificat

4.L Hygienic4.L.1 Introduct4.L.2 Surfaces4.L.3 Material: s4.L.4 Connectio4.L.5 Hoists and4.L.6 Pneumati4.L.7 Dosing sy4.L.8 Platforms4.L.9 Clean roo

5 Pharm

5.A Water typ5.A.1 Potable w5.A.2 Purified w5.A.3 Highly pu5.A.4 Water for

5.B Generati5.B.1 Purified w5.B.2 Water for5.B.3 Purificatio


Cont

ents


f containment facility planningent weak pointsent systems for filling and emptying drums systemsems

ent on equipment

ontrol systems sf process control systemse process control systemsut a process control system project

ion of process control systems

(sanitary) design when using solidsion

tainless steelns roller conveyors

c conveyor systemstems and standsm installations

aceutical Water

es ateraterrified water injection

on of pharmaceutical waterater (PW)

injection (WFI)n of pharmaceutical water treatment systems

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5.C Distribution and storage of pharmaceutical water5.C.1 Loop5.C.2 Fixtures 5.C.3 Measuring technique5.C.4 Formation of biofilms5.C.5 Rouging5.C.6 Buffering of ultra pure water5.C.7 Loop with subloops

5.D Qualification of water supplies5.D.1 Introduct5.D.2 Risk analy5.D.3 Design qu5.D.4 Installatio5.D.5 Operatio5.D.6 Transfer t5.D.7 Process va5.D.8 Qualificat

5.E Operatio5.E.1 Procedure5.E.2 Maintena5.E.3 Calibratio5.E.4 Change c5.E.5 Requalific5.E.6 Decommi

5.F Pure stea5.F.1 Physical p5.F.2 Quality re5.F.3 Pure steam5.F.4 Pure steam

6 Qualifi

6.A Official re6.A.1 Legal asp6.A.2 Documen6.A.3 Design Qu6.A.4 Installatio6.A.5 Operation6.A.6 Performan6.A.7 Qualificat6.A.8 Requalific


ionsisalification n qualification nal qualification (OQ)o the userlidation/performance qualification (PQ)

ion report

n of water supplies s to reduce microbial counts

nce of a water supplyn of measuring systemsontrol ation ssioning/uninstalling

m systemsrinciplesquirements for pure steam

generation distribution system

cation

quirementsects of qualificationtation of the qualificationalification (DQ)

n Qualification (IQ)al Qualification (OQ)ce Qualification (PQ)

ion of established facilities ation

GMP MANUAL Contents

6.B Preparation of the qualification 6.B.1 Commissioning6.B.2 Sequence6.B.3 Qualification team6.B.4 Responsibilities6.B.5 Qualification by external service providers6.B.6 Risk analysis

6.C Qualification documentation 6.C.1 Qualificat6.C.2 Qualificat6.C.3 Qualificat6.C.4 Labeling o6.C.5 SOP Qu

6.D Design q6.D.1 User requ6.D.2 Technical

6.E Installati6.E.1 Examples6.E.2 Example:

6.F Operatio6.F.1 Examples6.F.2 Example:

6.G Performa

6.H Special c6.H.1 Retrospec6.H.2 Requalific6.H.3 Content o6.H.4 Maintena6.H.5 Qualificat

7 Proces

7.A Official re7.A.1 Regulativ7.A.2 Principles7.A.3 Types of p7.A.4 Maintaini7.A.5 Documen

7.B Validatio7.B.1 What is th7.B.2 How is va


Cont

ents


ion master planion planion reportf the qualification statusalification of facilities and equipment

ualification (DQ) irements (user specifications) specification

on qualification (IQ) of IQ plansFluid bed equipment

nal qualification(OQ) of OQ plansFluid bed dryer

nce qualification (PQ)

ases of qualificationtive qualificationation f a review

nce of the qualified statusion of simple equipment

s Validation

quirementse aspects of process validationrocess validation

ng the validated statustation of process validation

n a key element of quality management e significance of validation?lidation defined?

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7.B.3 Who must perform validation?7.B.4 What faults can occur during validation?7.B.5 What are the benefits of validation? 7.B.6 Current trends in process validation7.B.7 Process validation from the viewpoint of the FDA

7.C Validation planning and procedure7.C.1 Process validation approaches7.C.2 Prerequisites and responsibilities 7.C.3 Scope of V

7.D Validatio7.D.1 Structure7.D.2 Validation7.D.3 Validation7.D.4 Validation7.D.5 Documen

7.E Process V7.E.1 Quality by7.E.2 Process A7.E.3 Maintaini7.E.4 Process va

7.F Referenc

8 Cleanin

8.A Official re

8.B How to v8.B.1 Optimiza8.B.2 Compilati8.B.3 Validating

8.C Cleaning

8.D Establish8.D.1 Bracketin8.D.2 Matrixing

8.E Acceptan8.E.1 Calculatio8.E.2 Calculatio8.E.3 Determin

8.F Sampling8.F.1 Swab test8.F.2 Rinse test


alidation

n documentation and archiving master plan protocol reporttation examples

alidation and Product Lifecycle Design

nalytical Technology (PAT) ng the validated statelidation as a three-stage life cycle model

es

g Validation

quirements

alidate cleaning procedurestion of cleaning procedureson of cleaning instructions manual and automated cleaning procedures

validation master plan

ing the scope of validationg: determination of critical substances: determination of equipment-specific validation protocols

ce criteria and limit calculationn of active pharmaceutical ingredient residues n of cleansing agent residuesation of the microbial status

procedures

GMP MANUAL Contents

8.F.3 Other procedures8.F.4 Selection of the appropriate sampling procedure8.F.5 Microbiological testing of surfaces

8.G Analytical procedures8.G.1 Requirements for method validation 8.G.2 Selection of the appropriate analytical procedure

8.H Documentation8.H.1 Validation8.H.2 Validation8.H.3 Other doc

8.I Maintena8.I.1 Changes 8.I.2 Change c8.I.3 Revalidat8.I.4 New prod8.I.5 Deviation

8.J Cleaning

8.K Referenc

9 Compu

9.A Introduct

9.B Legal asp9.B.1 Europe9.B.2 USA9.B.3 PIC/S9.B.4 Electronic9.B.5 ISPE GAM

9.C System li9.C.1 The V mo9.C.2 Software 9.C.3 Configura

9.D System c9.D.1 System cl9.D.2 Risk mana

9.E Validatio9.E.1 Validation9.E.2 Validation9.E.3 Specificat9.E.4 Unit, integ


Cont

ents


protocol reportuments

nce of the validated statusand deviationsontrol ionucts and equipments

validation documentation (example)

es

ter System Validation

ion and terminology

ects

signatures and electronic recordsP 5 Good Automated Manufacturing Practice

fe cycle del

developmenttion and customisation

lassification and risk management assification according to ISPE GAMP5gement

n of computerised systems organisation planions (user requirements/technical specification)ration, system and acceptance tests

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9.E.5 Validation report 9.E.6 Data migration and start-up9.E.7 Examples9.E.8 Retrospective validation

9.F Operation of computerised systems 9.F.1 System description9.F.2 User training9.F.3 Standard operating procedures (SOPs)9.F.4 Access an9.F.5 Data back9.F.6 Continge9.F.7 Change m9.F.8 Periodic r9.F.9 Retiremen

9.G External 9.G.1 Relocatio9.G.2 Service le9.G.3 Auditing

9.H Referenc

10 Consid

10.A Introduct10.A.1 Advantag10.A.2 Considera10.A.3 Regulator10.A.4 Objective10.A.5 Science-B10.A.6 Summary

10.B Basic ConProcess

10.B.1 Areas of H10.B.2 Prerequis10.B.3 Use of Kn10.B.4 Considera10.B.5 Elements 10.B.6 Implemen10.B.7 Commitm10.B.8 Project Te10.B.9 Analysis o10.B.10 Standardi10.B.11 Considera10.B.12 Additiona


d securityup and archiving

ncy plans anagement and error reporting

eviewt of computerised systems

service providers n of activitiesvel agreementof suppliers and service providers

es

erations on Risk Management

ion and Principleses of Risk Managementtions on the Risk-Based Approachy Environmentsased Approach

sideration on Implementing Risk Management Into a

azardsitesowledge and Experiencetion on Manual Operations of Risk Managementtation of a Risk Management Processent of Managementamf Existing Risk Management Approacheszation of Methods and Toolstions on Risk Based Behaviorl Training Required?

GMP MANUAL Contents

10.C Details on Using Risk Management Principles as Behavior10.C.1 Application to the QM System10.C.2 The Team 10.C.3 Assessment Criteria10.C.4 Procedure to Determine Conclusions10.C.5 Evaluation on Individual Topics (Detailed

Evaluation) Using Risk Management10.C.6 Example on Process Validation

10.D Methodo

10.E Using Pro

10.F Using a F10.F.1 Create a F10.F.2 Advantag

10.G Informal

10.H Fault Tre10.H.1 Basic Prin10.H.2 Objective10.H.3 How to Ru10.H.4 Prerequis10.H.5 Execution10.H.6 Advantag

10.I Failure M10.I.1 Objective10.I.2 General It10.I.3 Implemen10.I.4 Advantag10.I.5 Applicatio

10.J Hazard A10.J.1 Prerequis10.J.2 Advantag10.J.3 Applicatio

10.K Conclusio

11 Produc

11.A Sanitatio11.A.1 Organisat11.A.2 Sources o11.A.3 Responsib


Cont

ents


logies to be Used to Facilitate Risk Management

cess Mapping

ishbone Diagram ish Bone Diagrames and Disadvantages

Use of Risk Management

e Analysis (FTA)ciples: What a FTA Can Do and Where to Use Itn the Process of a FTA

ites for an FTA of an FTAes and Disadvantages of an FTA

ode Effects Analysis (FMEA)s and Areas of Applicationems on the FMEA Processtation of FMEA in a Projectes and Disadvantages of an FMEAn Example of a Modified FMEA

nalysis of Critical Control Points (HACCP)ite and Result to be Expectedes and Disadvantagesn Example

n

tion

nional prerequisitesf contaminationilities and implementation

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11.B Personnel hygiene11.B.1 Clothing11.B.2 Code of Conduct11.B.3 Hand disinfection11.B.4 Health requirements11.B.5 Training

11.C Production hygiene11.C.1 Sources of contamination11.C.2 Cleaning 11.C.3 Disinfecti

11.D Sanitatio11.D.1 Organisat11.D.2 Documen

11.E Environm11.E.1 General 11.E.2 Sampling11.E.3 Establishm11.E.4 Methods11.E.5 Investigat11.E.6 Evaluatio

11.F GMP in th

11.G Weigh-in11.G.1 Legal req11.G.2 Weigh-in 11.G.3 Weigh-in 11.G.4 Documen

11.H Identifica11.H.1 Handling 11.H.2 Labelling 11.H.3 Labelling 11.H.4 Labelling

11.I In-proces11.I.1 Objective11.I.2 Organisat11.I.3 Carrying o11.I.4 Documen

11.J Preventio11.J.1 Causes of11.J.2 Measures11.J.3 Manufact


on

n programmeion of room cleaningtation

ental monitoring

planent of limits and frequencies

ion areasn

e production process

uirementsprinciplesprocedure tation

tionof labelsof starting materialsof equipment and containersof rooms

s controls ion and responsibilities uttation and evaluation of data

n of cross-contamination cross-contamination to prevent cross-contamination ure of critical products

GMP MANUAL Contents

11.K Deviations11.K.1 Definition11.K.2 Procedure11.K.3 Responsibilities11.K.4 Measures11.K.5 Failure investigation report11.K.6 Evaluation of measures11.K.7 SOP deviations (example)11.K.8 Check-list for deviation handling

11.L Reworkin11.L.1 Definition11.L.2 Procedure11.L.3 Rework/R11.L.4 Rework o11.L.5 Rework o

11.M Warehou11.M.1 Regulator11.M.2 Stock man11.M.3 Responsib11.M.4 Personne11.M.5 Storage a11.M.6 Storage c11.M.7 Sanitation11.M.8 Material F11.M.9 Process F

11.N Transpor11.N.1 Requirem11.N.2 Transport11.N.3 Cool/Cold11.N.4 Temperat11.N.5 Transport

11.O Referenc

12 Sterile

12.A Introduct12.A.1 Manufact12.A.2 Aseptic p12.A.3 Sterilisatio12.A.4 GMP regu


Cont

ents


gs

eprocessing of rejected productsf returned products f products that have not been rejected

se and logisticsy requirementsagement systemilities

lreasonditions and pest controllow

low

tationents for logistic service providersation challenges and monitoring devices Chain Distributionure Profilesation Risks

es

Production

ionuring of terminally sterilised productsrocessing

n procedureslations, standards and guidelines

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12.B Air Lock Concepts12.B.1 Personnel locks in the clean area12.B.2 Material locks

12.C Manufacture of terminally sterilised products 12.C.1 Introduction12.C.2 Manufacturing a batch12.C.3 Washing processes12.C.4 Filling12.C.5 Validation

12.D Sterilisat12.D.1 Introduct12.D.2 Normativ12.D.3 Sterilisatio12.D.4 Steam ste12.D.5 Dry heat s12.D.6 Radiation

12.E Aseptic p12.E.1 Room req12.E.2 Monitorin12.E.3 Personne12.E.4 Sterile filt12.E.5 Validating

12.F Freeze-d12.F.1 The conce12.F.2 Freeze dr12.F.3 Process m12.F.4 Qualificat

12.G Testing f12.G.1 Introduct12.G.2 Parametri12.G.3 Sterility T

12.H Testing f12.H.1 Introduct12.H.2 Methods 12.H.3 Tests Acco12.H.4 Action Lim12.H.5 Gel-Clot T12.H.6 Photome12.H.7 Eliminatio12.H.8 Out of Sp


ion processesione background of sterilisation

n methods rilisationterilisation sterilisation

rocessinguirementsg

lration aseptic processing (media fill)

ryingpt of freeze-drying

yer designonitoring and control

ion and process validation in freeze-drying

or Sterilityionc releaseest

or Endotoxinsionfor detection of endotoxins

rding to Pharmacopeiaits

esttric Methodsn of Interfering Substances

ecification (OOS)

GMP MANUAL Contents

12.I Testing for Leakage and for Particles12.I.1 Testing for Leakage12.I.2 Testing for Particles12.I.3 Operating Procedure

12.J Microbiological monitoring12.J.1 Introduction12.J.2 Sources of contamination 12.J.3 Room classification 12.J.4 Monitoring program 12.J.5 Level12.J.6 Methods 12.J.7 Sampling12.J.8 Measures12.J.9 Organism

12.K Referenc

13 Packag

13.A Packagin13.A.1 Responsib13.A.2 Contents13.A.3 Materials13.A.4 Protection13.A.5 Packaging

13.B Packagin13.B.1 Allocation13.B.2 Line clear13.B.3 Labelling13.B.4 Control fu13.B.5 Release fo13.B.6 In-proces13.B.7 Cleaning 13.B.8 Labelling13.B.9 Variable d13.B.10 Imprints13.B.11 Reconcilia13.B.12 Safety fea13.B.13 Completio

13.C Qualifica13.C.1 Master qu13.C.2 Design qu13.C.3 Installatio


Cont

ents


and equipment

if levels are exceeded identification

es

ing

g material ilities

against counterfeit medicinal products material testing

g process of packaging material

ance

nctionsr production

s controlsprimary containers

ata

tionturesn of a packaging process

tion of a packaging line alification planalification (DQ)n qualification (IQ)

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13.C.4 Operational qualification (OQ)13.C.5 Performance qualification (PQ)

14 Laboratory Controls

14.A Sampling14.A.1 Requirements 14.A.2 Sampling plan (instructions)14.A.3 Notes for

14.B Reagents14.B.1 Labeling 14.B.2 Usage and14.B.3 Documen

14.C Standard14.C.1 Definition14.C.2 Handling,

14.D Qualifyin14.D.1 Qualificat14.D.2 System su

14.E Calibratio14.E.1 Definition14.E.2 Calibratio14.E.3 Examples14.E.4 Decision

14.F Validatio14.F.1 Principles14.F.2 Definition14.F.3 Documen14.F.4 Revalidat

14.G Stability 14.G.1 ICH guide14.G.2 Storage a14.G.3 Analyses14.G.4 Reduction14.G.5 Stability t14.G.6 Defining t

and the shdata (ICH

14.G.7 Decision tproducts

14.G.8 Procedure14.G.9 Examples


the sampling process

stability tation

s and reference substances of different standards and their areas of use storage and stability

g laboratory instrumentsion protocols and reports itability test (SST)

n in the labs n instructions and record

n of analytical methods s of the parameters tation

ion

testinglines for stability tests nd storage conditions

of the study design esting in the marketing phase he retest period for an active pharmaceutical ingredient elf life for a drug product through evaluation of stability

Q1E)ree for data evaluation for retest period or for APIs or drug (excluding frozen products) for statistical analysis

of the statistical evaluation of stability data

GMP MANUAL Contents

14.H Out-of-specification results14.H.1 Significance 14.H.2 Definitions 14.H.3 FDA OOS Guidance 14.H.4 Example for handling of an OOS result 14.H.5 Trend tracking

14.I Raw data documentation14.I.1 Principles 14.I.2 Single she

14.J Batch rel14.J.1 Certificati

in accorda14.J.2 Responsib14.J.3 Publicatio14.J.4 Release p

14.K Microbio14.K.1 Total micr14.K.2 Specified 14.K.3 Testing fr14.K.4 Miscellan

14.L Pharmac14.L.1 Structure14.L.2 General c14.L.3 Developm14.L.4 European14.L.5 British Ph14.L.6 United St14.L.7 Japanese14.L.8 Internatio14.L.9 Harmoniz

14.M Referenc

15 Docum

15.A Official R15.A.1 Basic Prin15.A.2 GMP-rele15.A.3 Requirem15.A.4 Documen15.A.5 Creating D15.A.6 Controllin


Cont

ents


et documentation system

easeon by a Qualified Person and release nce with EC GMP Guidelines ility for issuing the release n of release

rocedures in practice

logical testingobial count microorganismsequencieseous tests

opoeias of Pharmacopoeiasonsiderations

ent of Monographs Pharmacopoeia (Ph Eur)armacopoeia (BP)ates Pharmacopeia (USP) Pharmacopoeia (JP)nal Pharmacopoeia (Ph Int)ation

es

entation

equirementsciples of Documentationvant Documentsents of the US GMP Regulationst Management Systemocuments

g and monitoring documents

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ents

15.B GMP-conforming documentation 15.B.1 Handwritten entries15.B.2 Archiving15.B.3 Master-SOP GMP-conforming documentation

15.C Batch documentation15.C.1 Manufacturing instructions/record15.C.2 Packaging instruction and batch packaging record15.C.3 Electronic batch recording15.C.4 Testing p15.C.5 Batch reco

15.D Standard15.D.1 Compilati15.D.2 Approval 15.D.3 Training 15.D.4 Usage15.D.5 Review15.D.6 Changes15.D.7 Withdraw15.D.8 Administr15.D.9 Archiving15.D.10 Example o

administr

15.E Site Mast15.E.1 Introduct15.E.2 History15.E.3 Focus of r15.E.4 Regulator15.E.5 Guideline

15.F Annual pProduct q

15.F.1 Documen15.F.2 Annual pr15.F.3 Collabora15.F.4 Example: 15.F.5 Master-SO

15.G Referenc


rocedures and test protocolrd review

operating procedures (SOPs)on and implementation

ing an operating procedureation f an SOP Compilation and

ation of operating procedures

er Fileion

ecent update (PE 008-4)y requirementss for structure, contents and extent

roduct review /uality review

ts required for an annual product reviewoduct review reporttion with a contract manufacturerannual product reviewP for the annual product review

es

GMP MANUAL Contents

16 Research and Development

16.A General conditions and legal requirements

16.B Development phases and GMP requirements16.B.1 Formulation development16.B.2 Analytical development16.B.3 Manufacturing and testing of stability samples16.B.4 Packaging development16.B.5 Process d16.B.6 Cleaning 16.B.7 Process o

Basic prin16.B.8 Up scaling16.B.9 Handover

16.C Interface16.C.1 GLP Goo16.C.2 GCP Go16.C.3 Interfaces

and those

16.D Manufac16.D.1 Prerequis16.D.2 Manufact16.D.3 Packaging16.D.4 Control an16.D.5 Storage a16.D.6 Returns, r

16.E Documen

16.F Developm

16.G Quality b16.G.1 Introduct16.G.2 The Regu16.G.3 The New 16.G.4 Applying 16.G.5 Implemen16.G.6 Applicatio16.G.7 Outlook

16.H Referenc


Cont

ents


evelopmentverification and validation ptimization: ciples for process validation to pilot plant and production scale

to other manufacturing sites

s to GLP and GCPd Laboratory Practice

od Clinical Practice between the areas regulated by GMP regulated by GCP

ture and control of clinical samplesites for the approval of clinical investigationsuring of clinical samples and comparator drugs and labelingd release of investigational medicinal products

nd shipment of investigational drugsecalls and destruction of clinical samples

tation and recording of changes during development

ent report

y design (QbD)ionlatory FrameworkQuality Paradigm Quality by Designting Quality by Designn Examples

es

(20)

GMP MANUAL Contents

GMP Manual (Up14) M

Cont

ents

17 Contractors and Suppliers

17.A Contract manufacture17.A.1 Reasons for contract manufacture17.A.2 Procedure for assigning manufacturing contracts17.A.3 Duties of the contract giver17.A.4 Duties of the contract acceptor17.A.5 Contract manufacturer agreement17.A.6 Audits of 17.A.7 SOP for as17.A.8 Framewo

17.B Contract17.B.1 Introduct17.B.2 Legal bac17.B.3 Selection17.B.4 Liability li17.B.5 Certificate17.B.6 Transfer o

17.C Suppliers17.C.1 Introduct17.C.2 Definition17.C.3 Quality sy17.C.4 Records17.C.5 Contracts17.C.6 Supplier r17.C.7 Supplier a17.C.8 Re-evalua17.C.9 GMP MAN

17.D Referenc

18 Inspect

18.A Principle

18.B Inspectio18.B.1 System-b18.B.2 Product-b18.B.3 Procedure18.B.4 Area-base

18.C Inspector18.C.1 Technical18.C.2 Personal r


contract manufacturerssigning manufacturing contracts

rk contract for contract manufacture and quality control

Analysision kground of an external testing laboratorymitation contract of Analysisf the test to the contract laboratory

ionsstems

and quality agreements eview and controlsuditstion of SuppliersUAL Cross References to Suppliers

es

ions

s

n procedures asedased-basedd

s qualification requirementsequirements

GMP MANUAL Contents

18.D Organization of inspections18.D.1 Inspection planning18.D.2 Inspection preparation18.D.3 Carrying out the inspections18.D.4 Evaluation and documentation

18.E Self-inspection18.E.1 Purpose of self-inspection18.E.2 Carrying out the self-inspection18.E.3 Self-inspe18.E.4 Errors and18.E.5 Follow-up

18.F Inspectio18.F.1 Purpose o18.F.2 Carrying o18.F.3 Handling

18.G Inspectio18.G.1 Purpose o18.G.2 Carrying o

18.H Question

18.I Inspectio18.I.1 Preparatio18.I.2 Type of in18.I.3 Inspection

18.J Referenc

19 Quality

19.A General This chap

19.B The Qua19.B.1 Introduct19.B.2 Legal bac19.B.3 Qualificat19.B.4 Duties an19.B.5 Qualified

19.C Change M19.C.1 Principles19.C.2 Boundary19.C.3 Regulator19.C.4 Conductin


Cont

ents


ction documentation remedial action activities

n of contract manufacturers f the inspection of contract manufacturerut inspections of contract manufacturer

of changes and deviations

n of suppliersf the supplier inspectionut the supplier inspection

naire for preparing GMP-inspections

n of API manufacturersn of the inspection

spection questionnaire

es

Unit

ter will be part of a later update.

lified Person according to Directive 2001/83/ECionkground of the European Qualified Person regulationsion and experienced responsibilities Person and Pharmaceutical Quality Systems

anagement of Change Control Conditionsy aspectsg the Change Control Procedure

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GMP MANUAL Contents

GMP Manual (Up14) M

Cont

ents

19.C.5 Evaluating the Change Control System19.C.6 Documenting the Change Control

19.D Corrective and Preventive Actions (CAPA)19.D.1 Introduction19.D.2 Regulatory Background19.D.3 Definitions19.D.4 Organizational Integration19.D.5 Documentation and Tracking19.D.6 Efficacy a19.D.7 Efficient Im19.D.8 Sample SO

19.E Referenc

20 Contin

20.A Preface

20.B Six Sigma20.B.1 Definition20.B.2 What it is 20.B.3 Goals/Ob20.B.4 Implemen20.B.5 Tools20.B.6 Variations20.B.7 Examples

20.C Statistica20.C.1 Definition20.C.2 What it is 20.C.3 Goals/Ob20.C.4 Implemen20.C.5 Tools20.C.6 Variations20.C.7 Examples

20.D Process A20.D.1 Definition20.D.2 The Role o20.D.3 Regulator20.D.4 PAT instru20.D.5 Applicatio20.D.6 Examples

20.E Referenc


nd SustainabilityplementationP CAPA System

es

ual Improvement

/ what it does / how it worksjectives/Benefitstation

l Process Control (SPC)

/what it does / how it worksjectives/Benefitstation

nalytical Technology (PAT)

f PAT in Pharmaceutical Manufacturingy Perspective and Guidances mentationn of PAT in a GMP environment

of PAT Applications

es

GMP MANUAL Contents

21 Active and Inactive Ingredients

21.A GMP for Active Pharmaceutical Ingredients (APIs)21.A.1 Introduction21.A.2 Quality management21.A.3 Personnel21.A.4 Buildings and facilities21.A.5 Process equipment 21.A.6 Documentation and records 21.A.7 Materials 21.A.8 Productio21.A.9 Packaging21.A.10 Storage a21.A.11 Laborator21.A.12 Validation21.A.13 Change C21.A.14 Rejection21.A.15 Complain21.A.16 Contract m21.A.17 Agents, b21.A.18 Specific g

cell cultur21.A.19 APIs for u

21.B GMP for A21.B.1 Materials 21.B.2 Productio21.B.3 Re-use an21.B.4 Interactio

21.C Excipient21.C.1 Introduct21.C.2 Regulator21.C.3 Safety, to21.C.4 Compend21.C.5 Excipient 21.C.6 Applicabi21.C.7 Other asp

21.D Referenc


Cont

ents


management n and in-process controls and identification labelling of APIs and intermediates

nd distribution y controls ontrol and re-use of materialsts and Recalls

anufacturers, including laboratoriesrokers, traders, distributors, repackers, and relabellers uidance for APIs manufactured by e/fermentation se in clinical trials

PIs considerations on special topicsmanagementn and maintenance d recovery of materialsn with brokers

siony aspects and guidance documents xicological, and precedence of use issuesial monographsMaster Files and other filingslity of ICH guidance to excipientsects critical to the marketing of excipients

es

(24)

GMP MANUAL Contents

GMP Manual (Up14) M

Cont

ents

22 Biologics

23 Medical Devices

23.A Introduction23.A.1 Definition23.A.2 Types of medical devices23.A.3 Regulatory background23.A.4 Process ap

23.B Quality M23.B.1 Managem23.B.2 Quality m23.B.3 Quality po23.B.4 Quality pl23.B.5 Managem23.B.6 Audits

23.C Personne23.C.1 General23.C.2 Training23.C.3 Health, hy23.C.4 Consultan

23.D Design co23.D.1 General23.D.2 Design pl23.D.3 Design in23.D.4 Design ou23.D.5 Design re23.D.6 Design ve23.D.7 Design va23.D.8 Design tra23.D.9 Design ch23.D.10 Design hi

23.E Human fa

23.F Statistica

23.G Risk man

23.H Documen23.H.1 Control o23.H.2 Control o

23.I Productio23.I.1 Manufact23.I.2 Automate


proach to a Quality Management System

anagement System (QMS)ent responsibilityanuallicy

anningent review

l

giene, practices, and clothingts and contractors

ntrol

anningputtput

viewrificationlidation / Clinical evaluationnsferanges

story file

ctors

l techniques

agement

t and record controlf documentsf records

n and process controlsuring materialsd processes

GMP MANUAL Contents

23.I.3 Sterile products23.I.4 Changes23.I.5 Material acceptance procedures

23.J Identification and traceability23.J.1 Identification23.J.2 Traceability

23.K Buildings, facilities and equipment23.K.1 Buildings23.K.2 Environm23.K.3 Equipmen

23.L Validatio

23.M Purchasin23.M.1 Purchase 23.M.2 Quality ag

23.N Packagin23.N.1 Packaging23.N.2 Manufact

23.O Handling23.O.1 Handling 23.O.2 Storage23.O.3 Distributi23.O.4 Installatio23.O.5 Servicing

23.P Nonconfo23.P.1 Definition23.P.2 CAPA Sys23.P.3 Nonconfo23.P.4 Advisory

23.Q Custome23.Q.1 Complain23.Q.2 Complain

23.R Combina

23.S Referenc


Cont

ents


and facilitiesentt

n

g/supplier controlordersreements

g and labeling

urers information

, storage, distribution, installation and servicing

onn

rmance, Corrective Action and Preventive Actions

tem rming product

notice, device correction or product recall

r complaintst evaluationt investigation

tion products

es

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GMP MANUAL Contents

GMP Manual (Up14) M

Cont

ents

A Empty Register

B Empty Register

C EU Directives and Guidelines

C.1 EU GMP Guide: Introduction

C.2 Commission Directive 2003/94/EC

C.3 Commiss

C.4 Part I Basic Req

C.4.1 Chapter 1Pharmac

C.4.2 Chapter 2Personne

C.4.3 Chapter 3Premises

C.4.4 Chapter 4Documen

C.4.5 Chapter 5Productio

C.4.6 Chapter 6Quality C

C.4.7 Chapter 7Outsourc

C.4.8 Chapter 8Complain

C.4.9 Chapter 9Self Inspe

C.5 Part II Basic ReqMaterials

C.6.1 Annex 1 Manufac

C.6.2 Annex 2:ManufacProducts


C.6.4 Annex 4 ManufacImmunol


ion Directive 91/412/EEC

uirements for Medicinal Products

: eutical Quality System

:l

: and Equipment

:tation

:n

:ontrol

: ed Activities

: ts and Product Recall

:ction

uirements for Active Substances used as Starting

ture of Sterile Medicinal Products

ture of Biological active substances and Medicinal for Human Use

ture of Radiopharmaceuticals

ture of Veterinary Medicinal Products other than ogical Veterinary Medicinal Products

GMP MANUAL Contents

C.6.5 Annex 5 Manufacture of Immunological Veterinary Medicinal Products

C.6.6 Annex 6 Manufacture of Medicinal Gases

C.6.7 Annex 7 Manufacture of Herbal Medicinal Products

C.6.8 Annex 8 Sampling of Starting and Packaging Materials


C.6.10 Annex 10Manufacfor Inhala

C.6.11 Annex 11Compute

C.6.12 Annex 12Use of IonProducts

C.6.13 Annex 13Investiga

C.6.14 Annex 14Manufacor Plasma

C.6.15 Annex 15Qualifica

C.6.16 Annex 16Certificat

C.6.17 Annex 17Parametr

C.6.18 Annex 18Good MaIngredien

C.6.19 Annex 19Referenc

C.7 Glossary

C.8 Part III G

C.8.1 Explanat

C.8.2 Quality R

C.8.3 Pharmac

C.8.4 Internaticertificat


Cont

ents


ture of Liquids, Creams and Ointments

ture of Pressurised Metered Dose Aerosol Preparations

tion

rised Systems

ising Radiation in the Manufacture of Medicinal

tional Medicinal Products

ture of Medicinal Products Derived from Human Blood

tion and Validation

ion by a Qualified Person and Batch Release

ic Release

nufacturing Practice for Active Pharmaceutical ts

e and Retention Samples

MP related documents

ory Notes on the preparation of a Site Master File

isk Management (ICH Q9)

eutical Quality System (ICH Q10)

onally harmonised requirements for batch ion

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GMP MANUAL Contents

GMP Manual (Up14) M

Cont

ents

C.8.5 New Rules on Importing Active Pharmaceutical Ingredients into the European Union

C.8.5.1 Importation of Active Substances for Medicinal Products for Human Use Questions and Answers Version 1.0

C.9 Note For Guidance on Quality of Water for Pharmaceutical Use

C.10 Compilation of Community Procedures on Inspections and Exchange of Information

C.10.1 Conduct of Inspections of Pharmaceutical Manufacturers or Importers

C.10.2 Outline oGMP Stat

C.10.3 Guideline

C.10.4 GuidanceCompeteof ManufMaterials

C.10.5 The Issue

C.10.6 A Model Pharmac

C.10.7 Procedurvoiding/sadminist

C.11 EU Direct

C.11.1 Council Don the apto active (90/385/E

C.11.2 Council D(93/42/EE

C.11.3 Directive27 Octob(98/79/EC

C.12 DirectiveCouncil

C.13 Guideline


f a Procedure for Co-Ordinating the Verification of the us of Manufacturers in Third Countries

on Training and Qualifications of GMP Inspectors

on the Occasions when it is Appropriate for nt Authorities to Conduct Inspections at the Premises acturers of Active Substances Used as Starting

and Update of GMP Certificates

for Risk Based Planning for Inspections of eutical Manufacturers

e for dealing with serious GMP non-compliance or uspension of CEPS thus requiring co-ordinated

rative action

ives on Medical Devices

irective of 20 June 1990 proximation of the laws of the member states relating implantable medical devices EC)

irective of 14 June 1993 concerning medical devices C)

of the European Parliament and of the Council of er 1998 on in vitro diagnostic medical devices )

2001/83/EC of the European Parliament and of the

on Real Time Release Testing

GMP MANUAL Contents

D USA: CFR and FDA Guidelines

D.1 Code of Federal Regulations

D.1.1 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

D.1.2 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmac

D.1.3 21 CFR PaElectroni

D.1.4 21 CFR PaQuality S

D.2 GuidanceProcess V

D.3 Guide to of High P

D.4 Guide to of Valida

D.5 Guide to of oral sodevelopm

D.6 Guide to of Valida

D.7 Guide to Compute

D.8 Guide to of Pharm

D.9 GuidanceInvestigaTest Resu

D.10 GuidanceSterile DrGood Ma

D.11 GuidancePAT A FDevelopm

D.12 GuidancePart 11, EApplicati

D.13 GuidanceIncorporaDosage F


Cont

ents


euticals

rt 11 c Records; Electronic Signatures

rt 820ystem Regulation

for Industry alidation: General Principles and Practices

Inspections urity Water Systems

Inspections tion of Cleaning Processes

Inspections lid dosage forms pre/post approval issues for ent and validation

Inspections tion Documentation

Inspections rized Systems in Drug Establishments (2/83)

Inspections aceutical Quality Control Laboratories

for Industry ting Out-of-Specification (OOS) lts for Pharmaceutical Production

for Industry ug Products Produced by Aseptic Processing Current nufacturing Practice

for Industry ramework for Innovative Pharmaceutical

ent, Manufacturing, and Quality Assurance

for Industry lectronic Records; Electronic Signatures Scope and on

for Industrytion of Physical-Chemical Identifiers into Solid Oral

orm Drug Products for Anticounterfeiting

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Cont

ents

D.14 Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations

D.15 Guidance for Industry cGMP for Phase 1 Investigational Drugs

D.16 Federal Food, Drug, and Cosmetic Act (FD&C Act)

D.17 Pre-Approval Inspections

E ICH-Gu

E.1.A ICH Q1A(Stability

E.1.B ICH Q1B:Stability Substanc

E.1.C ICH Q1C:Stability

E.1.D ICH Q1D:BracketinDrug Sub

E.1.E ICH Q1E: Evaluatio

E.2 ICH Q2(RValidatioText and

E.3.A ICH Q3A(Impuritie

E.3.B ICH Q3B(Impuritie

E.3.C ICH Q3C(Impuritie

E.4 ICH Q4: Pharmac

E.4.A ICH Q4A:Pharmac

E.4.B ICH Q4B:EvaluatioUse in th

E.4.B.1 ICH Q4B Evaluatioof Pharmon ResiduGeneral C


idelines

R2): Testing of New Drug Substances and Products

Testing: Photostability Testing of New Drug es and Products

Testing for New Dosage Forms

g and Matrixing Designs for Stability Testing of New stances and Products

n of Stability Data

1): n of Analytical Procedures: Methodology

R2): s in New Drug Substances

R2): s in New Drug Products

R5): s: Guideline for Residual Solvents

opoeias

opoeial Harmonisation

n and Recommendation of Pharmacopoeial Texts for

e ICH Regions

Annex 1: n and Recommendation acopoeial Texts for Use in the ICH Regions e on Ignition/Sulphated Ash hapter

GMP MANUAL Contents

E.4.B.2 ICH Q4B Annex 2: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter

E.4.B.3 ICH Q4B Annex 3: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination: Sub-Visible Particles General C

E.4.B.4.1 ICH Q4B Evaluatioof PharmMicrobioof Non-StMicrobiaGeneral C

E.4.B.4.2 ICH Q4B Evaluatiofor Use inMicrobioTest for S

E.4.B.4.3 ICH Q4B Evaluatioof Pharmon Microof Non-StAcceptanSubstanc

E.4.B.5 ICH Q4B Evaluatioof Pharmon Disint

E.4.B.6 ICH Q4B Evaluatioof Pharmon Unifor

E.4.B.7 ICH Q4B Evaluatioof Pharmon Dissol

E.4.B.8 ICH Q4B Evaluatioof Pharmon Sterili

E.4.B.9 ICH Q4B Evaluatioof Pharmon Table


Cont

ents


hapter

Annex 4A: n and Recommendation acopoeial Texts for Use in the ICH Regions logical Examination erile Products:

l Enumerations Tests hapter

Annex 4B : n and Recommendation of Pharmacopoeial Texts the ICH Regions on

logical Examination of Non-Sterile Products: pecified Micro-Organisms General Chapter

Annex 4C: n and Recommendation acopoeial Texts for Use in the ICH Regions biological Examination erile Products: ce Criteria For Pharmaceutical Preparations and es for Pharmaceutical Use General Chapter

Annex 5: n and Recommendation acopoeial Texts for Use in the ICH Regions egration Test General Chapter

Annex 6: n and Recommendation acopoeial Texts for Use in the ICH Regions mity of Dosage Units General Chapter

Annex 7: n and Recommendation acopoeial Texts for Use in the ICH Regions ution Test General Chapter

Annex 8: n and Recommendation acopoeial Texts for Use in the ICH Regions ty Test General Chapter

Annex 9: n and Recommendation acopoeial Texts for Use in the ICH Regions

t Friability General Chapter

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GMP MANUAL Contents

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Cont

ents

E.4.B.10 ICH Q4B Annex 10: Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter

E.5.A ICH Q5A(R1): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin

E.5.B ICH Q5B: Quality of Biotechnological Products: Analysis of the Expression ConstrucProtein P

E.5.C ICH Q5C:Quality oBiotechn

E.5.D ICH Q5D:DerivatioProductio

E.5.E ICH Q5E: Comparato Chang

E.6.A ICH Q6A:SpecificaDrug Sub

E.6.B ICH Q6B:SpecificaBiotechn

E.7 ICH Q7:Good MaIngrediencombineGMPs forby Cefic/AInterpret

E.7.1 Chapter 1Introduct

E.7.2 Chapter 2Quality M

E.7.3 Chapter 3Personne

E.7.4 Chapter 4Buildings

E.7.5 Chapter 5Process E

E.7.6 Chapter 6Documen


t in Cells Used for Production of R-DNA Derived roducts

f Biotechnological Products: Stability Testing of ological/Biological Products

n and Characterisation of Cell Substrates used for n of Biotechnological/Biological Products

bility of Biotechnological/Biological Products Subject es in their Manufacturing Process

tions: Test Procedures and Acceptance Criteria for New stances and New Drug Products: Chemical Substances

tions: Test Procedures and Acceptance Criteria for ological/Biological Products

nufacturing Practice Guide for Active Pharmaceutical ts

d with APIs: How to do Document

PIC ation of the ICH Q7 Guide

:ion

:anagement

:l

: and Facilities

quipment

:tation and Records

GMP MANUAL Contents

E.7.7 Chapter 7:Materials Management

E.7.8 Chapter 8:Production and In-Process Controls

E.7.9 Chapter 9:Packaging and Identification Labelling of APIs and Intermediates

E.7.10 Chapter 10:Storage a

E.7.11 Chapter 1Laborato

E.7.12 Chapter 1Validatio

E.7.13 Chapter 1Change C

E.7.14 Chapter 1Rejection

E.7.15 Chapter 1Complain

E.7.16 Chapter 1Contract(includin

E.7.17 Chapter 1Agents, BRelabelle

E.7.18 Chapter 1Specific GFermenta

E.7.19 Chapter 1APIs for U

E.7.20 Chapter 2Glossary

E.8 ICH Q8 (RPharmac

E.9 ICH Q9: Quality R

E.10 ICH Q10:Pharmac

E.10.1 Quality Imon Q8, Q9Question


Cont

ents


nd Distribution

1:ry Controls

2:n

3:ontrol

4: and Re-use of Materials

5:ts and Recalls

6: Manufacturers g Laboratories)

7:rokers, Traders, Distributors, Repackers, and rs

8:uidance for APIs Manufactured by Cell Culture/tion

9:se in Clinical Trials

0:

2): eutical Development

isk Management

eutical Quality System

plementation Working Group and Q10

s & Answers

(34)

GMP MANUAL Contents

GMP Manual (Up14) M

Cont

ents

F PIC/S Guidelines

F.1 PIC/S PI 006-3: Recommendations on Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation

F.2 PIC/S PI 007-6: RecommValidatio

F.3 PIC/S PI 0PIC/S GuiGood PraCompute

F.4 PIC/S PI 0Aide-mmInspectio

F.4.1 Annex toAide-Memfor Inspe

F.5 PIC/S PE Explanatpreparat

F.6 PIC/S PI 0Aide-mmInspectio

F.7 PIC/S PI 0Aide-mmGMP Insp

F.8 PIC/S PI 0RecommGMP AnnInterpretof Sterile

F.9 PIC/S PE Guide to Intro

F.10 PIC/S PE Guide to Part I

F.11 PIC/S PE Guide to Part II

F.12 PIC/S PE Guide to Annexe


endation on the n of Aseptic Processes

11-3: dance ctices for rised Systems in Regulated GXP Environments

23-2: oire

n of Pharmaceutical Quality Control Laboratories

PIC/S PI 023-1 oire

ctions of Pharmaceutical Quality Control Laboratories

008-4: ory notes for pharmaceutical manufacturers on the ion of a Site Master File

09-3: oire

n of Utilities

28-1: oire

ection Related to Packaging

32-2: endationex 1 Revision 2008,ation of Most Important Changes for the Manufacture Medicinal Products

009-9: Good Manufacturing Practice for Medicinal Products



009-9: Good Manufacturing Practice for Medicinal Productss

GMP MANUAL Contents

G GMP of other Regions

G.1 WHO Guidelines

G.1.1 Quality assurance of pharmaceuticals

G.1.1.1 1. WHO good manufacturing practices: main principles for pharmaceutical products

G.1.1.2 2. WHO good manufacturing practices: starting materials

G.1.1.3 3. WHO specific p

G.1.1.4 4. Inspe

G.1.1.5 5. Hazar

G.1.1.6 6. Samp

G.1.2 WHO TRSGuide to

G.1.3 WHO TRSGood dis

G.1.4 WHO TRSModel gutemperat

G.2 Canadian

G.2.1 Good Ma2009 Edit

G.2.2 Canada: Good Ma

G.2.2.1 Annex 1 to the CuGuideline(GUI-006

G.2.2.2 Annex 2 to the CuGuideline



G.2.2.5 Annex 5 to the CuGuideline(GUI-007


Cont

ents


good manufacturing practices: harmaceutical products

ction

d and risk analysis in pharmaceutical products

ling operations

908 (2003), Annex 9: good storage practices for pharmaceuticals

957 (2010), Annex 5: tribution practices for pharmaceutical products

961 (2011), Annex 9: idance for the storage and transport of time- and ure-sensitive pharmaceutical products )

Regulations

nufacturing Practices (GMP) Guidelines ion, Version 2 (GUI-0001)

nufacturing Practices (GMP) Guidelines Annexes

rrent Edition of the Good Manufacturing Practices s Selected Category IV Monograph Drugs

6)

rrent Edition of the Good Manufacturing Practices s Schedule D Drugs, (Biological Drugs) (GUI-0027)

rrent Edition of the Good Manufacturing Practices s Schedule C Drugs (GUI-0026)

rrent Edition of the Good Manufacturing Practices s Veterinary Drugs (GUI-0012)

rrent Edition of the Good Manufacturing Practices s Positron Emitting Radiopharmaceuticals (PERs)

1)

(36)

GMP MANUAL Contents

GMP Manual (Up14) M

Cont

ents

G.2.2.6 Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials (GUI-0036)

G.2.2.7 Annex 14 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule D Drugs, Human Blood and Blood Components (GUI-0032)

G.3 Japanese Regulations

G.3.1 MHW MinRegulatio

G.3.2 MHLW MStandardCosmetic

G.3.3 MHLW MStandardDrugs an

G.4 Chinese R

G.4.1 China Good Ma

G.4.2 China: Good MaAnnex 1 tTechnica

G.4.2.1 Annex 1:Sterile M

G.4.2.2 Annex 2:Active Su

G.4.2.3 Annex 3:Biologica

G.4.2.4 Annex 4:Blood Pro

G.4.2.5 Annex 5:Chinese M

H Inform

H.1 GMP Abb

H.2 GMP Glos

H.3 Adresses

H.4 Referenc


isterial Ordinance No. 2,1961: ns for Buildings and Facilities of Pharmacies, etc.

inisterial Ordinance No. 136,2004 : s for Quality Assurance for Drugs, Quasi-drugs, s and Medical Devices

inisterial Ordinance No. 179, 2004: s for Manufacturing Control and Quality Control for d Quasi-drugs

egulations

nufacturing Practice for Drugs (2010 Revision)

nufacturing Practice (2010 revision)o Annex 5

l Reviewed by ISPE

edicinal Products

bstances Used As Starting Materials

l Medicinal

ducts

edicine Preparations

ation

reviations

sary

es