1 Quality Management Systems
1 Quality Management Systems
2 Personnel
2 Personnel
3 Premises
3 Premises
4 Facilities and Equipment
4 Facilities and Equipment
4.A Facility Planning
4.A Facility Planning
4.B Materials
4.B Materials
4.C Hygienic design in solids handling
4.C Hygienic design in solids handling
4.D System controllers and process control systems
4.D System controllers and process control systems
4.E Technical documentation
4.E Technical documentation
4.F Calibration
4.F Calibration
4.G Maintenance
4.G Maintenance
4.G.1 Key points at a glance
4.G.1 Key points at a glance
4.G.2 Maintenance strategies
4.G.2 Maintenance strategies
4.G.3 Implementation of a GMP-compliant maintenance system
4.G.3 Implementation of a GMP-compliant maintenance system
4.G.4 Implementation of IT systems for supporting maintenance management
4.G.4 Implementation of IT systems for supporting maintenance management
4.G.5 Maintenance requirements of the future
4.G.5 Maintenance requirements of the future
Summary
Summary
4.H Cleaning of facilities
4.H Cleaning of facilities
4.I Containment (personnel protection) in solids handling
4.I Containment (personnel protection) in solids handling
4.J References
4.J References
5 Pharmaceutical Water
5 Pharmaceutical Water
6 Qualification
6 Qualification
7 Process Validation
7 Process Validation
8 Cleaning Validation
8 Cleaning Validation
9 Computer System Validation
9 Computer System Validation
10 Hygiene
10 Hygiene
11 Production
11 Production
12 Sterile Production
12 Sterile Production
13 Packaging
13 Packaging
14 Laboratory Controls
14 Laboratory Controls
15 Documentation
15 Documentation
16 Research and Development
16 Research and Development
17 Contractors and Suppliers
17 Contractors and Suppliers
18 Inspections
18 Inspections
19 Quality Risk Management
19 Quality Risk Management
20 Continual Improvement
20 Continual Improvement
21 Active Pharmaceutical Ingredients
21 Active Pharmaceutical Ingredients
22 Excipients
22 Excipients
23 Medical Devices
23 Medical Devices
24 Storage and Transportation
24 Storage and Transportation
as of 2019 - 01 - 24

4.G Maintenance

4.G Maintenance
Here you will find answers to the following questions:
●

What does maintenance have to do with GMP?
●

How are the most important terms regarding maintenance defined?
●

What strategies for maintenance exist?
●

Can preventive maintenance improve product quality and be cost effective at the same time?
●

How can maintenance be implemented optimally?
●

How do you implement a GMP-compliant maintenance concept?
●

What do you need to consider when introducing an electronic maintenance management system?
●

Does maintenance management software have to be validated?
●

What does the future of maintenance look like?
4.G Maintenance
Summary
4.G.1 Key points at a glance
4.G.2 Maintenance strategies
4.G.2.1 Run-to-failure
4.G.2.2 Time-based periodic maintenance
4.G.2.3 Condition-based maintenance
4.G.2.4 Predictive maintenance
4.G.2.5 Risk-based maintenance
4.G.3 Implementation of a GMP-compliant maintenance system
4.G.3.1 Level 1: Improvisation
4.G.3.2 Level 2: Orientation
4.G.3.3 Level 3: Definition
4.G.3.4 Level 4: Implementation
4.G.3.5 Level 5: Optimisation
4.G.4 Implementation of IT systems for supporting maintenance management
4.G.4.1 Phase 1: Formation of a project team
4.G.4.2 Phase 2: Current state analysis
4.G.4.3 Phase 3: Target concept
4.G.4.4 Phase 4: Selection of hardware and software
4.G.4.5 Phase 5: Introduction of hardware and software
4.G.5 Maintenance requirements of the future

A paid subscription is needed to login into the GMP Compliance Adviser. Click here for more information.

Username
Password
enlarge font size by using the short cut 'ctrl' and '+' (from IE 7, Firefox)