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Contents
File 1 to 3
Quality Management
1.A
1.A.1
1.A.2
1.A.3
1.A.3.1
1.A.3.2
1.A.4
1.A.5
1.B
Documentation of a QM system
1.B.1
1.B.1.1
1.B.1.2
1.B.1.3
1.B.1.4
1.B.1.5
1.B.1.6
1.B.2
1.B.3
1.B.3.1
1.B.3.2
1.B.3.3
1.B.3.4
1.A (1)
1.A (3)
1.A (4)
1.A (4)
1.A (5)
1.A (7)
1.A (9)
Contents
1.B (1)
1.B (3)
1.B (4)
1.B (4)
1.B (4)
1.B (5)
1.B (6)
1.B (7)
1.B (9)
1.B (9)
1.B (11)
1.B (13)
1.B (17)
1.C
1.C.1
1.C.1.1
1.C.1.2
1.C.1.3
1.C.1.4
1.C.1.5
1.C.1.6
Management responsibility
Responsibility of key personnel
Responsibility of the management board
Definition of quality policy
Definition of quality objectives
Support of the quality management system
Deciding on resources
1.C (2)
1.C (2)
1.C (2)
1.C (5)
1.C (6)
1.C (6)
1.C (7)
(1)
Contents
Contents
1.C.1.7
1.C.2
1.C.2.1
1.C.2.2
1.C.2.3
1.C.2.4
1.C.3
1.C.3.1
1.C.3.2
1.C.3.3
1.C.3.4
1.C.3.5
1.C.3.6
1.C.4
1.C.4.1
1.C.4.2
1.C.5
1.C.5.1
1.C.6
1.C.6.1
1.C.6.2
1.C.6.3
1.C.6.4
1.C.7
1.C.7.1
1.C.7.2
1.C.7.3
1.C.7.4
1.C.8
1.C.8.1
1.C.8.2
1.C.8.3
1.C.9
1.C.9.1
1.C.9.2
1.C.10
1.C.10.1
1.C.10.2
1.C.10.3
1.C.10.4
(2)
Management review
Change management system
Definition of terms
Processing of changes and deviations
Processing of OOS results
Involvement of external companies
Complaints and recall
Definition of terms
Processing of complaints
Responsibilities
Compilation of a standard operating procedure (SOP)
Recall
Trend analysis
Corrective and Preventive Actions (CAPA)
Definitions
Quality management system for CAPA
Risk management
Aims of risk management
Qualification and validation
Tasks of the Quality Unit
Tasks of the management board
Quality management system for qualification
Quality management system for validation
Training
Compilation of a standard operating procedure (SOP)
Compilation of an annual program
Compilation of a training plan
Guaranteeing participation
Inspection
Compilation of a standard operating procedure
Contents of the audit program
Contents of an audit plan
Batch record review and annual product review
Batch record review
Annual product review
Qualification of suppliers and service providers
Responsibilities
Risk analysis for grading
Carrying out
Requalification
1.C (8)
1.C (9)
1.C (9)
1.C (10)
1.C (13)
1.C (14)
1.C (15)
1.C (15)
1.C (16)
1.C (16)
1.C (17)
1.C (21)
1.C (22)
1.C (22)
1.C (23)
1.C (23)
1.C (26)
1.C (27)
1.C (28)
1.C (29)
1.C (29)
1.C (30)
1.C (34)
1.C (35)
1.C (36)
1.C (36)
1.C (36)
1.C (37)
1.C (37)
1.C (38)
1.C (38)
1.C (39)
1.C (42)
1.C (42)
1.C (44)
1.C (45)
1.C (50)
1.C (50)
1.C (51)
1.C (54)
Contents
Personnel
2.A
2.B
2.B.1
2.B.2
Qualification requirements
Health requirements
2.C
Training
2.C.1
2.C.2
2.C.3
2.C.4
2.C.5
2.C.6
2.C.6.1
2.C.6.2
2.C.6.3
2.C.7
2.C.8
Purpose of training
Responsibility for training
Requirements profiles/learning objectives
Training contents and target groups
Training planning
Carrying out
External factors
Qualification of the trainer
Training methods
Reviewing the training and the training system
Documentation
Premises
3.A
Official requirements
3.B
General requirements
3.B.1
3.B.2
3.B.3
3.B.4
3.B.5
3.B.6
3.C
3.C.1
3.C.2
3.C.3
Material flow
Personnel flow
Layout
3.D
Room classes
3.E
Construction elements
3.E.1
3.E.2
3.E.3
3.E.4
Walls
Doors and windows
Floors
Ceilings
2.B (1)
2.B (2)
2.C (1)
2.C (1)
2.C (2)
2.C (3)
2.C (4)
2.C (4)
2.C (4)
2.C (5)
2.C (5)
2.C (8)
2.C (11)
Contents
3.B (1)
3.B (2)
3.B (3)
3.B (4)
3.B (4)
3.B (4)
3.C (1)
3.C (2)
3.C (4)
3.E (1)
3.E (5)
3.E (7)
3.E (9)
(3)
Contents
3.F
Building services
3.G
Room qualification
3.H
3.H.1
3.H.2
3.H.2.1
3.H.2.2
3.H.2.3
Introduction
Room ventilation systems
Pure (100%) external air conditioning system
Central recirculating air/mixed air conditioning system
Decentralised recirculating air/mixed air conditioning
system with central external air preparation
Pure recirculating air conditioning system
Systems for tempering and volume flow regulation
Control-systems of the air volume flows
Utilities for the operation of room ventilation systems
Filters
Particle air filter
Suspended matter filter HEPA-Filter
Principles for the design and planning
of air conditioning ventilation systems
Design criteria for the ventilation of premises
Air technology design of a sterile room with negative
pressure plenum
Pressure stages and design of the pressure differential
measurement for a sterile area
Maintenance of air ventilation systems
Time intervals for carrying out inspections or servicing
Tolerances for inspection and servicing deadlines
Maintenance plan
Forms for the inspection and servicing of ventilation systems
Log book for air technology systems
Qualification of air conditioning
ventilation systems
Contents
3.H.2.4
3.H.2.5
3.H.2.6
3.H.2.7
3.H.3
3.H.3.1
3.H.3.2
3.H.4
3.H.5
3.H.5.1
3.H.5.2
3.H.6
3.H.6.1
3.H.6.2
3.H.6.3
3.H.6.4
3.H.6.5
3.H.7
(4)
4.A
Introduction
4.B
Mechanical components
4.B.1
4.B.2
4.B.3
3.H (1)
3.H (2)
3.H (3)
3.H (4)
3.H (5)
3.H (6)
3.H (6)
3.H (8)
3.H (8)
3.H (9)
3.H (11)
3.H (14)
3.H (20)
3.H (25)
3.H (26)
3.H (27)
3.H (33)
3.H (36)
3.H (36)
3.H (37)
3.H (37)
3.H (47)
3.H (49)
4.B (1)
4.B (2)
4.B (3)
Contents
Control
4.D
Facility concepts
4.D.1
4.D.2
4.D.3
4.E
4.E.1
4.E.2
4.E.3
Design qualification
Installation qualification
Operational qualification
4.F
Technical documentation
4.F.1
4.F.2
4.F.3
4.F.4
Necessity
Scope and content
Administration of the technical documentation
Log book
4.G
Calibration
4.G.1
4.G.2
4.G.3
4.G.4
Definitions
Procedure
Documentation
Administration of scheduled calibration dates/times
4.H
Maintenance
4.H.1
4.H.2
4.H.3
Types of maintenance
GMP-conform maintenance
Systems for maintenance
4.I
4.I.1
4.I.1.1
4.I.1.2
4.I.2
4.I.2.1
4.I.2.2
4.I.3
4.I.3.1
4.I.3.2
4.I.3.3
4.I.3.4
4.I.3.5
4.I.3.6
4.I.4
4.I.4.1
4.I.4.2
Introduction
Definition
Cleaning mechanisms
CIP systems
CIP facility for stack cleaning
CIP facility for lost cleaning
GMP-conform design of CIP facilities
Influences of the surfaces
Requirements for pipes and tanks
Requirements for bonding elements and seals
Requirements for pumps
Requirement for valves
Requirements for measuring instruments
Nozzle heads for container cleaning
Spray ball
Rotating nozzle head
4.D (1)
4.D (2)
4.D (3)
4.E (1)
4.E (5)
4.E (10)
4.F (1)
4.F (2)
4.F (8)
4.F (10)
Contents
4.C
4.G (1)
4.G (2)
4.G (4)
4.G (4)
4.H (1)
4.H (2)
4.H (3)
4.I (1)
4.I (1)
4.I (2)
4.I (3)
4.I (3)
4.I (4)
4.I (6)
4.I (6)
4.I (6)
4.I (7)
4.I (7)
4.I (9)
4.I (9)
4.I (10)
4.I (10)
4.I (11)
(5)
Contents
Contents
4.I.4.3
4.I.5
4.I.5.1
4.I.5.2
4.I.5.3
4.I.5.4
4.I.6
4.J
4.J.1
4.J.1.1
4.J.1.2
4.J.2
4.J.3
4.J.3.1
4.J.4
4.J.5
Significance
Use of isolators
Working in the full protection suit
Definition of terms
Containment grades of products in accordance with OEL
Measurement of the OEL values.
Containment weak points
Containment systems for filling and emptying
barrels and big bags
Barrel filling with endless liner
Barrel filling and emptying with DCS
(Drum Containment System)
Big bag emptying and filling with a protective foil system
Container systems
Container with outlet cone for emptying
Containment Transfer Unit (CTU) at the container inlet for filling
Split valve systems
Laminar flow, glove box systems (isolators)
Filter systems
Sampling
Containment on equipment
Practical example of a containment API plant
4.J.5.1
4.J.5.2
4.J.5.3
4.J.6
4.J.6.1
4.J.6.2
4.J.6.3
4.J.6.4
4.J.7
4.J.8
4.J.9
4.J.10
(6)
4.K
4.K.1
4.K.2
4.K.3
4.K.4
4.K.5
Definitions
Features of process control systems
How to use process control systems
Carrying out a process control system project
Qualification of process control systems
Pharmaceutical Water
5.A
Water types
5.A.1
5.A.2
5.A.3
Potable water
Purified water
Water for injection
4.I (11)
4.I (11)
4.I (12)
4.I (12)
4.I (13)
4.I (13)
4.I (13)
4.J (1)
4.J (2)
4.J (2)
4.J (2)
4.J (3)
4.J (5)
4.J (6)
4.J (7)
4.J (7)
4.J (9)
4.J (12)
4.J (13)
4.J (14)
4.J (15)
4.J (16)
4.J (17)
4.J (18)
4.J (19)
4.J (21)
4.J (23)
4.K (1)
4.K (2)
4.K (5)
4.K (6)
4.K (7)
5.A (1)
5.A (3)
5.A (4)
Contents
5.B
5.B.1
5.B.1.1
5.B.1.2
5.B.1.3
5.B.1.4
5.B.1.5
5.B.1.6
5.B.1.7
5.B.1.8
5.B.2
5.B.2.1
5.B.3
5.C
5.C.1
5.C.1.1
5.C.1.2
5.C.1.3
5.C.1.4
5.C.1.5
5.C.2
5.C.2.1
5.C.2.2
5.C.2.3
5.C.2.4
5.C.3
5.C.3.1
5.C.3.2
5.C.3.3
5.C.3.4
5.C.3.5
5.C.3.6
5.C.3.7
5.C.4
5.C.5
5.C.5.1
5.C.5.2
5.C.5.3
5.C.5.4
5.C.5.5
5.C.6
5.C.7
Loop
Flow rate and turbulent flow
Pipes
Requirements of welds
Dead end piping
Use of plastics (PVDF)
Fixtures
Valves
Sensors
Sterile filter
Sampling points
Measuring technique
Level measurement
Flow measurement
Conductivity measurement
Pressure measurement
Temperature measurement
Ozone measurement (online)
TOC measurement (online)
Formation of biofilms
Rouging
What is rouging?
Impact on the water quality
Handling rouging
How can you detect rouging?
Measures against rouging
Buffering of ultra pure water
Loop with subloops
5.A (6)
5.B (2)
5.B (2)
5.B (2)
5.B (3)
5.B (4)
5.B (6)
5.B (8)
5.B (9)
5.B (9)
5.B (10)
5.B (11)
5.B (14)
5.C (1)
5.C (2)
5.C (3)
5.C (4)
5.C (5)
5.C (6)
5.C (6)
5.C (6)
5.C (7)
5.C (7)
5.C (7)
5.C (7)
5.C (8)
5.C (12)
5.C (15)
5.C (16)
5.C (18)
5.C (19)
5.C (19)
5.C (20)
5.C (22)
5.C (22)
5.C (23)
5.C (23)
5.C (24)
5.C (25)
5.C (26)
5.C (28)
Contents
5.A.4
(7)
Contents
Contents
5.C.7.1
5.C.7.2
(8)
5.D
5.D.1
5.D.2
5.D.3
5.D.3.1
5.D.3.2
5.D.3.3
5.D.3.4
5.D.4
5.D.4.1
5.D.4.2
5.D.4.3
5.D.5
5.D.5.1
5.D.5.2
5.D.6
5.D.6.1
5.D.7
5.D.7.1
5.D.7.2
5.D.7.3
5.D.8
Introduction
Risk analysis
Design qualification
User requirements
Technical specification
Test protocol
Test record
Installation qualification
Facility documentation
Test protocol
IQ test record
Operational qualification (OQ)
Test protocol (OQ)
OQ test record
Handover to the user
Handover report
Process validation/performance qualification (PQ)
Microbiological tests for pharmaceutical water
Determination of alert and action limits
Sampling
Qualification report
5.E
5.E.1
5.E.1.1
5.E.1.2
5.E.1.3
5.E.2
5.E.2.1
5.E.2.2
5.E.2.3
5.E.3
5.E.4
5.E.4.1
5.E.5
5.E.5.1
5.E.5.2
5.E.6
5.E.6.1
5.E.6.2
5.C (28)
5.C (29)
5.D (1)
5.D (3)
5.D (8)
5.D (8)
5.D (10)
5.D (13)
5.D (14)
5.D (17)
5.D (17)
5.D (20)
5.D (24)
5.D (28)
5.D (30)
5.D (33)
5.D (37)
5.D (37)
5.D (43)
5.D (43)
5.D (44)
5.D (45)
5.D (46)
5.E (1)
5.E (1)
5.E (2)
5.E (3)
5.E (4)
5.E (6)
5.E (8)
5.E (9)
5.E (10)
5.E (11)
5.E (11)
5.E (13)
5.E (13)
5.E (13)
5.E (14)
5.E (14)
5.E (14)
Contents
5.F.1
5.F.2
5.F.2.1
5.F.2.2
5.F.3
5.F.3.1
5.F.3.2
5.F.3.3
5.F.3.4
5.F.3.5
5.F.3.6
5.F.4
5.F.4.1
5.F.4.2
5.F.4.3
5.F.4.4
5.F.4.5
5.F.4.6
5.F.4.7
Physical principles
Quality requirements for pure steam
DIN EN 285 (1997-2)
DIN 58950 part 7 (April 2003)
Pure steam generation
Degassing
Natural circulation procedure
Downdraft procedure
Pure steam generator with external heat exchanger
Separation systems
Quality-relevant measuring points
Pure steam distribution system
Planning and layout
Condensate drain
Insulation
Pressure reducing valve
Safety valve
Pipe connections
Sampling cooler
Qualification
6.A
Official requirements
6.A.1
6.A.2
6.A.3
6.A.4
6.A.5
6.A.6
6.A.7
6.A.8
6.B
6.B.1
6.B.2
6.B.3
6.B.4
6.B.5
6.B.5.1
Commissioning
Sequence
Qualification team
Responsibilities
Qualification by external service providers
Integration of external capacities ("consultants")
into the qualification process
Transfer of parts of qualification activities to
consulting engineers
Transfer of qualification activities to suppliers, acquisition
of qualification packages
6.B.5.2
6.B.5.3
5.F (1)
5.F (3)
5.F (3)
5.F (4)
5.F (5)
5.F (5)
5.F (6)
5.F (7)
5.F (7)
5.F (8)
5.F (9)
5.F (9)
5.F (9)
5.F (14)
5.F (18)
5.F (18)
5.F (19)
5.F (19)
5.F (20)
Contents
5.F
6.A (1)
6.A (3)
6.A (4)
6.A (7)
6.A (8)
6.A (9)
6.A (10)
6.A (12)
6.B (1)
6.B (4)
6.B (5)
6.B (6)
6.B (6)
6.B (7)
6.B (7)
6.B (7)
(9)
Contents
Contents
6.B.6
6.B.6.1
6.B.6.2
6.B.6.3
(10)
Risk analysis
Risk analysis during the life cycle of a facility
Organisation of risk analysis
Implementation of the risk analysis
6.C
Qualification documentation
6.C.1
6.C.2
6.C.3
6.C.4
6.C.5
6.D
6.D.1
6.D.1.1
6.D.1.2
6.D.2
6.E
6.E.1
6.E.1.1
6.E.1.2
6.E.1.3
6.E.1.4
6.E.1.5
6.E.1.6
6.E.1.7
6.E.1.8
6.E.2
Examples of IQ plans
Materials and lubricants
Supply of (energy and media) utilities
Measuring and control technology points and initial calibration
Calibration records
P & I diagrams
Pipes
Technical documentation
IQ report
Example: Fluid bed equipment
6.F
Operational qualification(OQ)
6.F.1
6.F.1.1
6.F.1.2
6.F.1.3
6.F.1.4
6.F.2
Examples of OQ plans
Safety devices
Risk analysis Operating functions
Check for the presence of screw caps
OQ report
Example: Fluid bed dryer
6.G
6.H
6.H.1
6.H.2
6.H.3
6.H.4
6.H.5
Retrospective qualification
Requalification
Content of a review
Maintenance of the qualified status
Qualification of simple equipment
6.B (10)
6.B (10)
6.B (11)
6.B (12)
6.C (2)
6.C (3)
6.C (9)
6.C (10)
6.C (11)
6.D (3)
6.D (5)
6.D (8)
6.D (12)
6.E (3)
6.E (4)
6.E (7)
6.E (9)
6.E (11)
6.E (13)
6.E (16)
6.E (18)
6.E (21)
6.E (23)
6.F (3)
6.F (4)
6.F (6)
6.F (8)
6.F (11)
6.F (13)
6.H (1)
6.H (1)
6.H (3)
6.H (5)
6.H (7)
Contents
Process Validation
7.A
Official requirements
7.A.1
7.A.2
7.A.3
Legal aspects
The object of and procedure for process validation
Process validation documentation
7.B
7.C
7.C.1
7.C.2
7.C.3
Prospective validation
Retrospective validation
Concurrent validation
7.D
Revalidation
7.D.1
7.D.2
7.D.2.1
7.D.2.2
7.D.2.3
7.D.2.4
7.E
7.E.1
7.E.2
7.E.3
7.E.4
7.E.4.1
7.E.4.2
7.F
7.F.1
7.F.2
7.F.3
7.F.4
Validation matrix
Example of a validation master plan
Example for a validation matrix
Example for a test plan
7.G
Risk analysis
7.G.1
7.G.2
7.H
7.H.1
7.H.2
7.H.2.1
7.A (1)
7.A (2)
7.A (8)
7.C (1)
7.C (2)
7.C (5)
7.D (1)
7.D (2)
7.D (2)
7.D (4)
7.D (5)
7.D (5)
Contents
7.E (1)
7.E (4)
7.E (5)
7.E (6)
7.E (10)
7.E (11)
7.F (4)
7.F (6)
7.F (17)
7.F (24)
7.G (1)
7.G (1)
7.H (1)
7.H (9)
7.H (10)
(11)
Contents
7.H.2.2
Cleaning Validation
8.A
Official requirements
8.B
8.B.1
8.B.2
8.B.3
Contents
8.C
7.H (11)
8.B (1)
8.B (5)
8.B (7)
8.D
8.D.1
8.D.2
8.E
8.E.1
8.E.2
8.E.3
(12)
8.F
Sampling procedures
8.F.1
8.F.2
8.F.3
8.F.4
8.F.5
Swab test
Rinse test
Other procedures
Selection of the appropriate procedure
Microbiological testing of surfaces
8.G
Analytical procedures
8.G.1
8.G.2
8.H
Documentation
8.H.1
8.H.2
8.H.3
Validation protocol
Validation report
Other documents
8.I
8.I.1
8.I.2
8.I.3
8.I.3.1
8.I.3.2
8.D (1)
8.D (5)
8.E (1)
8.E (9)
8.E (10)
8.F (1)
8.F (3)
8.F (6)
8.F (7)
8.F (8)
8.G (1)
8.G (6)
8.H (1)
8.H (3)
8.H (7)
8.I (2)
8.I (2)
8.I (3)
8.I (3)
8.I (6)
Contents
8.J
Computer Validation
10
Risk Management
10.A
Principles
10.A.1
10.A.2
10.A.2.1
10.A.2.2
10.A.2.3
10.A.3
10.A.3.1
10.B
10.B.1
10.B.2
10.B.3
10.B.4
10.B.5
10.B.5.1
10.B.5.2
10.B.5.3
10.B.5.4
10.B.5.5
Risk fields
Prerequisite
Knowledge and experience
Elements of risk management
Implementation of a risk management process
Commitment of management
Project team
Analysis of current status
Standardisation of methods
Training
10.C
10.C.1
10.C.1.1
10.C.1.2
10.C.2
10.D
10.D.1
10.D.2
10.D.2.1
10.D.2.2
8.I (7)
8.I (8)
8.I (8)
8.I (10)
10.A (1)
10.A (2)
10.A (3)
10.A (4)
10.A (7)
10.A (7)
10.A (8)
Contents
8.I.4
8.I.4.1
8.I.4.2
8.I.5
10.B (1)
10.B (3)
10.B (4)
10.B (4)
10.B (5)
10.B (6)
10.B (6)
10.B (6)
10.B (7)
10.B (7)
10.C (1)
10.C (2)
10.C (4)
10.C (5)
10.C (5)
10.D (2)
10.D (3)
10.D (4)
10.D (4)
(13)
Contents
10.D.3
Informal method
10.D.3.1 Example
10.E
10.E.1
10.E.2
10.E.3
10.E.4
10.E.5
10.F
10.F.1
10.F.2
10.F.2.1
10.F.2.2
Contents
10.F.2.3
10.F.2.4
10.F.2.5
10.F.3
10.F.4
10.F.5
10.F.5.1
10.F.5.2
10.F.6
10.G
10.G.1
10.G.2
10.G.3
10.G.4
10.G.5
10.H
10.H.1
Prerequisite and result
10.H.2
Execution
10.H.2.1 Step 1: Analysis and identification of potential risks
(hazard analysis)
10.H.2.2 Step 2: Determination of the critical control points
(Critical Control Points, CCP)
10.H.2.3 Step 3: Determining the Critical Control Points (CCP)
10.H.2.4 Step 4: In-process control, monitoring of critical control points
10.H.2.5 Step 5: Determining corrective action
10.H.2.6 Step 6: Documentation of processes
10.H.2.7 Step 7: Verification of the HACCP system
(14)
10.D (6)
10.D (6)
10.E (1)
10.E (1)
10.E (2)
10.E (3)
10.E (4)
10.F (2)
10.F (2)
10.F (4)
10.F (4)
10.F (9)
10.F (14)
10.F (14)
10.F (15)
10.F (16)
10.F (16)
10.F (16)
10.F (19)
10.F (20)
10.G (1)
10.G (2)
10.G (4)
10.G (5)
10.G (8)
10.H (2)
10.H (3)
10.H (3)
10.H (4)
10.H (5)
10.H (5)
10.H (6)
10.H (6)
10.H (7)
Contents
11
Production
11.A
Sanitation
11.B
Personnel hygiene
11.B.1
11.B.2
11.B.3
11.B.4
11.B.5
11.B.6
Clothing
Personnel hygiene
Code of conduct
Hand disinfection
Health requirements
Training
11.C
Production hygiene
11.C.1
11.C.2
11.C.3
Sources of contamination
Cleaning
Disinfection
11.D
Sanitation programme
11.D.1
11.D.2
11.E
Environmental monitoring
11.E.1
11.E.2
11.E.2.1
11.E.3
11.E.4
Sampling plan
Establishment of limits and frequencies
Methods
Investigation areas
Evaluation
11.F
11.G
Weigh-in
11.G.1
11.G.2
11.G.3
11.G.4
Legal principles
Weigh-in principles
Weigh-in procedure
Weighing process sequence
11.H
Identification
11.H.1
11.H.2
11.H.3
Starting materials
Labelling in the manufacturing process
Labelling of rooms
10.H (7)
10.H (8)
10.H (8)
10.H (9)
11.B (1)
11.B (11)
11.B (11)
11.B (12)
11.B (13)
11.B (13)
Contents
10.H.3
10.H.4
10.H.4.1
10.H.4.2
11.C (3)
11.C (6)
11.C (7)
11.D (1)
11.D (6)
11.E (1)
11.E (2)
11.E (4)
11.E (6)
11.E (7)
11.G (1)
11.G (3)
11.G (4)
11.G (6)
11.H (2)
11.H (3)
11.H (6)
(15)
Contents
Contents
(16)
11.I
In-process control
11.I.1
11.I.2
11.I.3
11.I.4
11.I.5
11.I.6
Objectives
Organisation
Carrying out
Documentation
Scope of tests and limits
Responsibilities
11.J
Prevention of cross-contamination
11.J.1
11.J.2
11.J.3
11.J.4
11.J.5
11.J.6
11.K
Deviations
11.K.1
11.K.2
11.K.3
11.K.4
11.K.5
11.K.6
11.K.7
Definition
Sequence
Responsibilities
Measures
Failure investigation report
Evaluation
SOP "deviations" (example)
11.L
Reworking
11.L.1
11.L.2
11.M
11.M.1
11.M.1.1
11.M.1.2
11.M.1.3
11.M.1.4
11.M.2
11.M.2.1
11.M.2.2
11.M.2.3
11.M.2.4
11.M.2.5
11.M.2.6
11.M.3
11.M.3.1
11.M.3.2
11.M.4
11.I (1)
11.I (3)
11.I (4)
11.I (6)
11.I (7)
11.I (7)
11.J (1)
11.J (2)
11.J (3)
11.J (3)
11.J (4)
11.J (4)
11.K (1)
11.K (2)
11.K (4)
11.K (4)
11.K (5)
11.K (7)
11.K (8)
11.L (1)
11.L (4)
11.M (1)
11.M (1)
11.M (2)
11.M (2)
11.M (3)
11.M (4)
11.M (4)
11.M (4)
11.M (5)
11.M (5)
11.M (6)
11.M (7)
11.M (8)
11.M (8)
11.M (10)
11.M (11)
Contents
12
Sterile Production
12.A
Introduction
12.A.1
12.A.2
12.A.3
12.A.4
12.B
12.B.1
12.B.1.1
12.B.1.2
12.B.1.3
12.B.1.4
12.B.2
12.C
12.C.1
12.C.1.1
12.C.1.2
12.C.1.3
12.C.2
12.C.3
12.C.4
12.C.4.1
12.C.4.2
12.C.4.3
12.C.4.4
12.C.4.5
Starting materials
Rooms used for weighing
Processing instructions (manufacturing instructions)
Weighing of starting materials
Solution batch
Testing the bioburden
Sterile filtration
History
Mode of operation
Materials, designs and properties
Filter integrity test
Executing sterile filtration
12.D
Washing processes
12.D.1
12.D.1.1
12.D.1.2
12.D.2
12.D.2.1
12.D.3
12.D.3.1
12.D.3.2
12.D.3.3
12.D.3.4
Stoppers
Material
Manufacture
Particulate impurities
Stopper washing
Glass containers (ampoules, bottles)
Types of glass
Manufacture
Washing
Ready to fill
11.M (15)
11.M (16)
12.A (2)
12.A (3)
12.A (4)
12.A (7)
12.B (1)
12.B (2)
12.B (2)
12.B (3)
12.B (4)
12.B (7)
Contents
11.M.5
11.M.6
12.C (1)
12.C (2)
12.C (2)
12.C (3)
12.C (4)
12.C (8)
12.C (9)
12.C (9)
12.C (10)
12.C (10)
12.C (11)
12.C (12)
12.D (1)
12.D (1)
12.D (2)
12.D (3)
12.D (4)
12.D (5)
12.D (5)
12.D (6)
12.D (6)
12.D (8)
(17)
Contents
12.D.4
Transport
12.E
Filling
Contents
12.E.1
12.E.1.1
12.E.2
12.E.3
(18)
12.F
Steam sterilisation
12.F.1
12.F.2
12.F.2.1
12.F.2.2
12.F.2.3
12.F.3
12.F.3.1
12.F.3.2
12.F.4
12.F.4.1
12.F.4.2
12.F.4.3
12.F.4.4
12.F.4.5
Sterilisers
Description of the procedure
Sterilisation
Drying
Sterilisation kinetics
Qualification of a steam steriliser
Installation qualification
Operational qualification
Validation of the steam sterilisation process
Description of equipment and process
Loading configurations
Bioindicators
Determining the sterilisation time
Executing the validation
12.G
Microbiological monitoring
12.G.1
12.G.2
12.G.3
12.G.3.1
12.G.3.2
12.G.3.3
12.G.4
12.G.4.1
12.G.5
12.G.6
12.G.7
Sources of contamination
Room classification
Monitoring program
Limits (level)
Methods and equipment
Microbiological testing of surfaces and personnel
Sampling
Frequencies
Sampling points
Measure if levels are exceeded
Organism identification
12.H
12.H.1
Parametric release
12.D (8)
12.E (1)
12.E (1)
12.E (5)
12.E (8)
12.E (8)
12.E (8)
12.E (13)
12.E (13)
12.E (14)
12.F (1)
12.F (2)
12.F (3)
12.F (4)
12.F (4)
12.F (6)
12.F (7)
12.F (9)
12.F (11)
12.F (12)
12.F (16)
12.F (19)
12.F (19)
12.F (20)
12.G (1)
12.G (2)
12.G (4)
12.G (4)
12.G (10)
12.G (12)
12.G (17)
12.G (18)
12.G (20)
12.G (22)
12.G (24)
12.H (1)
Contents
Sterility test
Environmental conditions
Environmental monitoring
Method description
Incubation
Number of samples
Sample quantity
Reading and evaluating
Procedure in the event of culture medium turbidity
Culture media
Culture media controls
Method validation
12.I
12.I.1
12.I.1.1
12.I.1.2
12.I.1.3
12.I.1.4
12.I.1.5
12.I.2
12.I.2.1
12.I.2.2
12.I.2.3
12.I.3
12.J
Freeze drying
12.J.1
12.J.1.1
12.J.2
12.J.2.1
12.J.2.2
12.J.3
12.J.3.1
12.J.3.2
12.K
12.K.1
12.K.2
12.K.3
12.K.3.1
12.K.3.2
12.K.4
12.K.4.1
12.K.4.2
12.H (3)
12.H (6)
12.H (6)
12.H (10)
12.H (11)
12.H (11)
12.H (12)
12.H (12)
12.H (15)
12.H (16)
12.H (17)
12.H (18)
12.I (1)
12.I (1)
12.I (3)
12.I (3)
12.I (3)
12.I (5)
12.I (5)
12.I (6)
12.I (8)
12.I (9)
12.I (12)
Contents
12.H.2
12.H.2.1
12.H.2.2
12.H.3
12.H.3.1
12.H.4
12.H.5
12.H.6
12.H.7
12.H.8
12.H.9
12.H.10
12.J (1)
12.J (4)
12.J (6)
12.J (7)
12.J (8)
12.J (9)
12.J (9)
12.J (10)
12.K (2)
12.K (3)
12.K (5)
12.K (5)
12.K (6)
12.K (8)
12.K (8)
12.K (9)
(19)
Contents
12.K.4.3
12.K.4.4
12.K.4.5
12.K.4.6
Contents
13
(20)
12.K (10)
12.K (10)
12.K (10)
12.K (11)
Packaging
13.A
Packaging material
13.A.1
13.A.2
13.A.3
13.A.4
13.A.5
13.A.5.1
13.A.5.2
13.A.5.3
13.A.5.4
13.A.5.5
Responsibilities
Contents
Materials
Protection against counterfeit medicinal products
Packaging material testing
Control tests carried out at the supplier
Examples
Defect evaluation lists
Storage
Labelling
13.B
Packaging process
13.B.1
13.B.2
13.B.3
13.B.4
13.B.5
13.B.6
13.B.6.1
13.B.6.2
13.B.6.3
13.B.7
13.B.8
13.B.9
13.B.10
13.B.11
13.B.12
13.B.13
13.C
13.C.1
13.C.2
13.C.2.1
13.C.2.2
13.C.3
13.C.3.1
13.C.3.2
13.A (2)
13.A (2)
13.A (2)
13.A (6)
13.A (7)
13.A (7)
13.A (8)
13.A (9)
13.A (11)
13.A (12)
13.B (2)
13.B (3)
13.B (6)
13.B (6)
13.B (8)
13.B (15)
13.B (15)
13.B (18)
13.B (20)
13.B (21)
13.B (21)
13.B (22)
13.B (23)
13.B (24)
13.B (26)
13.B (26)
13.C (2)
13.C (11)
13.C (11)
13.C (14)
13.C (28)
13.C (28)
13.C (33)
Contents
14
Quality Control
14.A
Sampling
14.A.1
14.A.1.1
14.A.1.2
14.A.1.3
14.A.1.4
14.A.2
14.A.3
14.A.3.1
14.A.3.2
14.A.3.3
Requirements
Personnel
Equipment
Containers
Premises
Sampling plan (instructions)
Notes for the sampling process
Containers and identification labelling
Sampling report
Reference samples
14.B
Reagents
14.B.1
14.B.2
14.B.3
Labelling
Usage and stability
Documentation
13.C (41)
13.C (41)
13.C (47)
13.C (55)
13.C (55)
13.C (59)
14.A (2)
14.A (2)
14.A (2)
14.A (2)
14.A (3)
14.A (3)
14.A (5)
14.A (5)
14.A (5)
14.A (8)
Contents
13.C.4
13.C.4.1
13.C.4.2
13.C.5
13.C.5.1
13.C.5.2
14.B (2)
14.B (2)
14.B (3)
14.C
14.C.1
14.C.2
14.D
14.D.1
14.D.1.1
14.D.1.2
14.D.1.3
14.D.1.4
14.D.2
14.E
14.E.1
14.E.1.1
14.E.1.2
14.E.1.3
14.E.2
14.E.2.1
14.E.3
Definitions
Persons
Instruments
Working
Calibration instructions and record
Test intervals, test points, test instructions
Examples
14.C (1)
14.C (4)
14.D (2)
14.D (2)
14.D (3)
14.D (4)
14.D (4)
14.D (5)
14.E (1)
14.E (1)
14.E (1)
14.E (2)
14.E (2)
14.E (3)
14.E (3)
(21)
Contents
Contents
14.E.3.1
14.E.3.2
14.E.3.3
14.E.3.4
14.E.4
14.E.4.1
14.E.4.2
14.E.4.3
14.F
14.F.1
14.F.2
14.F.2.1
14.F.2.2
14.F.2.3
14.F.2.4
14.F.2.5
14.F.2.6
14.F.2.7
14.F.3
14.F.4
Principles
Definitions of the parameters
Precision
Accuracy
LOD = Limit of Detection
LOQ = Limit of Quantitation
Selectivity
Linearity, Range
Robustness
Documentation
Revalidation
14.G
Stability testing
14.G.1
14.G.2
14.G.2.1
14.G.2.2
14.G.2.3
14.G.2.4
14.G.2.5
14.G.2.6
14.G.2.7
14.G.2.8
14.G.3
14.G.3.1
14.G.3.2
14.G.3.3
14.G.3.4
14.G.3.5
14.G.3.6
14.G.3.7
14.G.3.8
14.G.3.9
14.G.4
(22)
Balance
Volume measuring instruments
Photometer
HPLC system
Decision
Requirements, tolerances, specifications
Equipment release
Out of calibration
14.E (3)
14.E (5)
14.E (7)
14.E (9)
14.E (18)
14.E (18)
14.E (18)
14.E (18)
14.F (1)
14.F (2)
14.F (2)
14.F (3)
14.F (3)
14.F (4)
14.F (4)
14.F (4)
14.F (4)
14.F (5)
14.F (5)
14.G (2)
14.G (3)
14.G (3)
14.G (6)
14.G (7)
14.G (7)
14.G (8)
14.G (9)
14.G (9)
14.G (11)
14.G (12)
14.G (13)
14.G (14)
14.G (14)
14.G (14)
14.G (14)
14.G (15)
14.G (17)
14.G (18)
14.G (18)
14.G (19)
Contents
14.G.6.1
14.G.6.2
14.G.6.3
14.G.7
14.G.8
14.G.9
14.G.9.1
14.G.9.2
14.G.9.3
Bracketing
14.G (19)
Matrixing
14.G (20)
Stability testing in the marketing phase
14.G (23)
Follow-up stability testing (FuST)
14.G (23)
Stability commitment (SC)
14.G (24)
Defining the retest period for an active
pharmaceutical ingredient and the shelf life for a
drug product through evaluation of stability data
(ICH Q1E)
14.G (35)
Data evaluation for the retest period for APIs and shelf life
for drug products that are intended for storage at room
temperature
14.G (35)
Data evaluation for period for APIs and shelf life
for drug products intended for storage
in refrigerator (28 C)
14.G (37)
Date evaluation for retest period for APIs and shelf life
for drug products for intended storage
in a freezer (20 C)
14.G (37)
Decision tree for data evaluation for retest period
or for APIs or drug products (excluding frozen products) 14.G (38)
Procedure for statistical analysis
14.G (38)
Examples of the statistical evaluation of stability data
14.G (38)
Data analysis for a single batch
14.G (38)
Data analysis of one attribute in each batch for several batches
of the same product (known as One-Factor, Full-Design Studies) 14.G (41)
Data analysis of all attributes for several batches
(Multi-Factor, Full-Design Studies)
14.G (41)
14.H
Out-of-specification results
14.H.1
14.H.1.1
14.H.1.2
14.H.2
14.H.3
14.H.4
14.H.5
Significance
The BARR Laboratories case
The consequences
Definitions
FDA Draft Guidance and Comments
Example for handling of an OOS result
Trend tracking
14.I
14.I.1
14.I.2
14.I.2.1
14.I.2.2
14.I.2.3
Principles
Single sheet documentation system
Cover sheet
Data sheet
Index sheet
Contents
14.G.4.1
14.G.4.2
14.G.5
14.G.5.1
14.G.5.2
14.G.6
14.H (1)
14.H (1)
14.H (2)
14.H (3)
14.H (5)
14.H (9)
14.H (16)
14.I (1)
14.I (3)
14.I (3)
14.I (3)
14.I (7)
(23)
Contents
14.J
Batch release
14.J.1
15
Official requirements
15.A.1
Contents
15.B
GMP-conforming documentation
15.B.1
15.B.2
15.B.3
Handwritten entries
Archiving
Master-SOP "GMP-conforming documentation"
15.C
Batch documentation
15.C.1
15.C.1.1
15.C.1.2
15.C.1.3
15.C.2
15.C.2.1
15.C.2.2
15.C.3
15.C.3.1
Manufacturing instructions/record
Manufacturing instructions
Batch processing record
Master of manufacturing instructions/batch processing record
Packaging instruction and batch packaging record
Packaging instruction
Batch packaging record
Electronic batch recording
Strategic objectives of an Electronic Batch Recording System
(EBRS)
GMP aspects
Testing procedures and test protocol
Testing procedures
Test protocol
Batch record review
Regulatory requirements
Benefits of an independent batch record review
Responsibility and competencies
Scope of a batch record review
15.C.3.2
15.C.4
15.C.4.1
15.C.4.2
15.C.5
15.C.5.1
15.C.5.2
15.C.5.3
15.C.5.4
(24)
Documentation
15.A
15.A.2
15.A.3
15.A.4
14.J (1)
14.J (2)
14.J (3)
14.J (5)
14.J (6)
14.J (7)
14.J (8)
15.A (1)
15.A (4)
15.A (8)
15.A (12)
15.B (1)
15.B (2)
15.B (3)
15.C (3)
15.C (3)
15.C (4)
15.C (5)
15.C (25)
15.C (25)
15.C (26)
15.C (26)
15.C (27)
15.C (28)
15.C (29)
15.C (29)
15.C (31)
15.C (33)
15.C (33)
15.C (33)
15.C (34)
15.C (34)
Contents
15.D
15.D.1
15.D.1.1
15.D.1.2
15.D.2
15.D.3
15.D.4
15.D.5
15.D.6
15.D.7
15.D.8
15.D.8.1
15.D.8.2
15.D.8.3
15.D.8.4
15.D.9
15.D.10
Compilation
Design and format
Identification
Approval and implementation
Training
Usage
Review
Changes
Withdrawing an operating procedure
Administration
Status identification
Distribution
Integration
Use of computerised systems
Archiving
Example of an SOP "Compilation and
administration of operating procedures"
15.E
15.E.1
15.E.2
15.E.2.1
15.E.2.2
15.E.2.3
15.E.2.4
15.E.2.5
15.E.2.6
15.E.2.7
15.E.2.8
15.E.2.9
15.E.2.10
Introduction
Design
General information
Personnel
Premises and equipment
Documentation
Production
Quality control
Contract manufacturing and contract qualitiy control
Distribution, complaints and product recalls
Self-inspection
Appendix
15.F
15.F.1
15.F.2
15.F.3
15.F.4
15.F.5
15.C (36)
15.D (2)
15.D (4)
15.D (6)
15.D (7)
15.D (7)
15.D (8)
15.D (8)
15.D (9)
15.D (9)
15.D (10)
15.D (10)
15.D (10)
15.D (10)
15.D (11)
15.D (11)
Contents
15.D (12)
15.E (1)
15.E (1)
15.E (2)
15.E (3)
15.E (3)
15.E (5)
15.E (7)
15.E (8)
15.E (8)
15.E (9)
15.E (9)
15.E (10)
15.F (3)
15.F (4)
15.F (6)
15.F (7)
15.F (12)
(25)
Contents
Contents
16
17
Contract Manufacturing
and Analysis
17.A
Contract manufacture
17.A.1
17.A.2
17.A.3
17.A.3.1
17.A.3.2
17.A.3.3
17.A.3.4
17.A.3.5
17.A.4
17.A.4.1
17.A.4.2
17.A.4.3
17.A.4.4
17.A.4.5
17.A.4.6
17.A.4.7
17.A.5
17.A.5.1
17.A.5.2
17.A.5.3
17.A.5.4
17.A.5.5
17.A.6
17.A.6.1
17.A.6.2
17.A.6.3
17.A.6.4
17.A.6.5
17.A.6.6
17.A.6.7
17.A.7
17.A.8
(26)
17.B
Contract Analysis
17.B.1
17.B.2
Introduction
Legal basis
17.A (1)
17.A (3)
17.A (8)
17.A (9)
17.A (10)
17.A (11)
17.A (11)
17.A (11)
17.A (11)
17.A (12)
17.A (12)
17.A (12)
17.A (13)
17.A (15)
17.A (15)
17.A (16)
17.A (16)
17.A (17)
17.A (17)
17.A (19)
17.A (19)
17.A (19)
17.A (20)
17.A (20)
17.A (21)
17.A (22)
17.A (22)
17.A (27)
17.A (27)
17.A (27)
17.A (28)
17.A (34)
17.B (1)
17.B (1)
Contents
17.B.3
17.B.4
17.B.5
17.B.5.1
17.B.6
17.B.6.1
17.B.6.2
17.B.6.3
17.B.6.4
18
Inspections
18.A
Principles
18.B
Inspection procedures
18.B.1
18.B.2
18.B.3
18.B.4
System-based
Product-based
Procedure-based
Area-based
17.B (3)
17.B (3)
17.B (4)
17.B (6)
17.B (9)
17.B (9)
17.B (9)
17.B (10)
17.B (11)
18.C
Inspectors
18.C.1
18.C.2
18.D
Organisation of inspections
18.D.1
18.D.2
18.D.3
18.D.3.1
18.D.3.2
18.D.3.3
18.D.3.4
18.D.4
Inspection planning
Inspection preparation
Carrying out the inspections
Opening discussion
Site inspection
Documentation check
Concluding discussion
Evaluation and documentation
18.E
Self-inspection
18.E.1
18.E.2
18.E.3
18.E.4
18.E.5
Purpose of self-inspection
Carrying out the self-inspection
Self-inspection documentation
Errors and remedial action
Follow-up activities
18.F
18.F.1
18.F.2
18.F.3
Contents
18.B (1)
18.B (2)
18.B (2)
18.B (3)
18.C (1)
18.C (3)
18.D (1)
18.D (3)
18.D (4)
18.D (4)
18.D (5)
18.D (6)
18.D (7)
18.D (8)
18.E (1)
18.E (1)
18.E (3)
18.E (9)
18.E (12)
18.F (1)
18.F (1)
18.F (3)
(27)
Contents
Contents
(28)
18.G
Inspection of suppliers
18.G.1
18.G.2
18.H
18.I
Supplier qualification
18.I.1
18.I.2
18.I.3
18.I.3.1
18.I.3.2
18.I.3.3
18.I.3.4
18.I.3.5
18.I.3.6
18.I.3.7
19
19.A
Project management
19.A.1
19.A.2
19.A.2.1
19.A.2.2
19.A.2.3
19.A.3
19.A.3.1
19.A.3.2
19.A.3.3
19.A.4
19.A.4.1
19.A.4.2
19.A.4.3
19.A.5
19.A.6
19.A.6.1
19.A.6.2
19.A.6.3
19.A.7
19.B
Risk analysis
19.B.1
18.G (1)
18.G (2)
18.I (1)
18.I (3)
18.I (4)
18.I (5)
18.I (14)
18.I (15)
18.I (16)
18.I (16)
18.I (27)
18.I (28)
19.A (1)
19.A (2)
19.A (2)
19.A (2)
19.A (2)
19.A (3)
19.A (4)
19.A (4)
19.A (5)
19.A (5)
19.A (5)
19.A (5)
19.A (6)
19.A (6)
19.A (9)
19.A (9)
19.A (9)
19.A (9)
19.A (10)
19.B (1)
Contents
19.B.3.1
19.B.3.2
19.B.4
19.B.4.1
19.B.4.2
19.B.4.3
19.B.4.4
19.B.5
19.B.5.1
19.B.5.2
19.B.5.3
19.B.5.4
19.B.5.5
19.C
Change control
19.C.1
19.C.2
19.C.3
20
21
References
19.B (4)
19.B (4)
19.B (4)
19.B (5)
19.B (9)
19.B (11)
19.B (13)
19.B (13)
19.B (16)
19.B (26)
19.B (26)
19.B (27)
19.B (28)
19.B (28)
19.B (37)
19.B (39)
19.B (40)
19.B (40)
19.B (41)
19.B (42)
Contents
19.B.2
19.B.2.1
19.B.2.2
19.B.2.3
19.B.2.4
19.B.2.5
19.B.3
19.C (1)
19.C (4)
19.C (9)
(29)
Contents
Contents
(30)
Contents
Contents file 4 to 5
Index file 4 to 5
Information
B.1
B.2
B.3
List of Abbreviations
Glossary
Adress-Register
EU GMP Guide
C.1
C.2
C.3
C.4
Introduction
Commission Directive 2003/94/EC
Directive 91/412/EEC
Part I
Basic Requirements for Medicinal Products
Part II
Basic Requirements for Active Substances used as Starting
Materials
Annex 1
Manufacture of Sterile Medicinal Products
Annex 2
Manufacture of Biological Medicinal Products for Human
Use
Annex 3
Manufacture of Radiopharmaceuticals
Annex 4
Manufacture of Veterinary Medicinal Products other than
Immunological Veterinary Medicinal Products
Annex 5
Manufacture of Immunological Veterinary Medicinal
Products
Annex 6
Manufacture of medicinal gases
Annex 7
Manufacture of Herbal Medicinal Products
Annex 8
Sampling of Starting and Packaging Materials
C.5
C.6.1
C.6.2
C.6.3
C.6.4
C.6.5
C.6.6
C.6.7
C.6.8
Contents
(31)
Contents
C.6.9
C.6.10
C.6.11
C.6.12
C.6.13
C.6.14
Contents
C.6.15
C.6.16
C.6.17
C.6.18
C.6.19
C.7
C.8
C.9
C.9
D.1
D.1
(32)
Annex 9
Manufacture of Liquids, Creams and Ointments
Annex 10
Manufacture of Pressurised Metered Dose Aerosol
Preparations for Inhalation
Annex 11
Computerised Systems
Annex 12
Use of Ionising Radiation in the Manufacture of Medicinal
Products
Annex 13 Revision 1
Manufacture of Investigational Medicinal Products
Annex 14 Revision
Manufacture of medicinal Products derived from human
Blood or Plasma
Annex 15
Final Version Qualification and validation
Annex 16
Final Version: Certification by a Qualified Person and Batch
Release
Annex 17
Final version Parametric Release
Annex 18
Final version Good Manufacturing Practice for Active
Pharmaceutical Ingredients
Annex 19
Reference Samples and Retention Samples
Glossary
Index EU GMP Guide
C.1 to C.6.19
Note For Guidance on Quality of Water for Pharmaceutical
Use
Index C.9
D.1
D.12
21 CFR Part 11
Electronic records; electronic signature
Index chapter D.1
Guideline on General Principles of Process Validation
Index chapter D.2
Guide to Inspections of High Purity Water Systems
Index chapter D.3
Guide to Inspections of Validation of Cleaning Processes
Index chapter D.4
Guide to inspections of oral solid dosage forms pre/post
approval issues for development and validation
Index chapter D.5
Guide to Inspections of Validation Documentation
Index chapter D.6
Guide to Inspection of Computerized Systems in Drug
Processing
Index chapter D.7
Guide to Inspections of Pharmaceutical Quality Control
Laboratories
Index chapter D.8
Guidance for Industry
Investigating out of specification (OOS) test results for
pharmaceutical production
Index chapter D.9
Guidance for Industry
Sterile Drug Products Produced by Aseptic Processing
Current Good Manufacturing Practice
Index chapter D.10
Guidance for Industry
PAT A Framework for Innovative Pharmaceutical
Development, Manufacturing, and Quality Assurance
Index chapter D.11
Guidance for Industry
Part 11, Electronic Records; Electronic Signatures Scope
and Application
Index chapter D.12
ICH-Guidelines
E.1
D.1
D.2
D.2
D.3
D.3
D.4
D.4
D.5
D.5
D.6
D.6
D.7
D.7
D.8
D.8
D.9
D.9
D.10
D.10
D.11
D.11
D.12
E.1
Contents
Contents
(33)
Contents
E.2
E.2
E.3
E.4
E.4
E.5
E.5
E.6
Contents
E.6
E.7
E.7
E.8
E.8
PIC/S Guidelines
F.1
F.1
F.2
F.2
F.3
F.3
F.4
F.4
F.4
(34)
Contents
WHO Guidelines
G.1
G.1
Empty Register
Contents
(35)
Contents
Contents
(36)