gmp manual
TRANSCRIPT
-
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
-
(2)
GMP MANUAL Contents
GMP Manual (Up14) M
Cont
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
GMPIVZ-Druck.fm Seite 3 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(3)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
-
(4)
GMP MANUAL Contents
GMP Manual (Up14) M
Cont
ents
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
GMPIVZ-Druck.fm Seite 4 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 5 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(5)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
-
(6)
GMP MANUAL Contents
GMP Manual (Up14) M
Cont
ents
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
GMPIVZ-Druck.fm Seite 6 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 7 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(7)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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?
-
(8)
GMP MANUAL Contents
GMP Manual (Up14) M
Cont
ents
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
GMPIVZ-Druck.fm Seite 8 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 9 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(9)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
-
(10)
GMP MANUAL Contents
GMP Manual (Up14) M
Cont
ents
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
GMPIVZ-Druck.fm Seite 10 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 11 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(11)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
-
(12)
GMP MANUAL Contents
GMP Manual (Up14) M
Cont
ents
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
GMPIVZ-Druck.fm Seite 12 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 13 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(13)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
-
(14)
GMP MANUAL Contents
GMP Manual (Up14) M
Cont
ents
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
GMPIVZ-Druck.fm Seite 14 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 15 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(15)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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)
-
(16)
GMP MANUAL Contents
GMP Manual (Up14) M
Cont
ents
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
GMPIVZ-Druck.fm Seite 16 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 17 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(17)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
-
(18)
GMP MANUAL Contents
GMP Manual (Up14) M
Cont
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
GMPIVZ-Druck.fm Seite 18 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 19 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(19)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 20 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 21 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(21)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
-
(22)
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
GMPIVZ-Druck.fm Seite 22 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 23 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(23)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 24 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 25 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(25)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
-
(26)
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.6.3 Annex 3 Manufac
C.6.4 Annex 4 ManufacImmunol
GMPIVZ-Druck.fm Seite 26 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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.6.9 Annex 9 Manufac
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
GMPIVZ-Druck.fm Seite 27 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(27)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
-
(28)
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
GMPIVZ-Druck.fm Seite 28 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 29 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(29)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
-
(30)
GMP MANUAL Contents
GMP Manual (Up14) M
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
GMPIVZ-Druck.fm Seite 30 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 31 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(31)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
-
(32)
GMP MANUAL Contents
GMP Manual (Up14) M
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
GMPIVZ-Druck.fm Seite 32 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 33 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(33)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 34 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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 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.2.2.3 Annex 3 to the CuGuideline
G.2.2.4 Annex 4 to the CuGuideline
G.2.2.5 Annex 5 to the CuGuideline(GUI-007
GMPIVZ-Druck.fm Seite 35 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstore
Cont
ents
(35)GMP Manual (Up14) Maas & Peither AG GMP Publishing
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
GMPIVZ-Druck.fm Seite 36 Mittwoch, 26. September 2012 1:00 13www.pda.org/bookstoreaas & Peither AG GMP Publishing
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