1 Quality Management Systems
1 Quality Management Systems
1.A Pharmaceutical quality system (PQS)
1.A Pharmaceutical quality system (PQS)
1.A.1 The aims and basic principles of the PQS
1.A.1 The aims and basic principles of the PQS
1.A.2 Resources
1.A.2 Resources
1.A.3 Quality policy, quality planning and quality objectives
1.A.3 Quality policy, quality planning and quality objectives
1.A.4 PQS tools
1.A.4 PQS tools
1.A.5 Knowledge management
1.A.5 Knowledge management
1.A.6 Practical implementation of the PQS
1.A.6 Practical implementation of the PQS
Summary
Summary
1.B The documentation of the pharmaceutical quality system (PQS)
1.B The documentation of the pharmaceutical quality system (PQS)
1.C Quality Assurance Duties
1.C Quality Assurance Duties
1.D Change Management
1.D Change Management
1.E Deviations
1.E Deviations
1.F Corrective and Preventive Actions (CAPA)
1.F Corrective and Preventive Actions (CAPA)
1.G Complaints and Product Recalls
1.G Complaints and Product Recalls
1.H IT Systems for the Optimisation of Quality Management Processes
1.H IT Systems for the Optimisation of Quality Management Processes
1.I Batch Record Review
1.I Batch Record Review
1.J Product Quality Review and Annual Product Review
1.J Product Quality Review and Annual Product Review
1.K Fight against counterfeit medicines
1.K Fight against counterfeit medicines
1.L Outsourced activities
1.L Outsourced activities
1.M Management review
1.M Management review
1.N References
1.N References
2 Personnel
2 Personnel
3 Premises
3 Premises
4 Facilities and Equipment
4 Facilities and Equipment
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
1.A Pharmaceutical quality system (PQS)
1.A.1 The aims and basic principles of the PQS
1.A.2 Resources
1.A.3 Quality policy, quality planning and quality objectives
1.A.3.1 How is a quality policy defined?
1.A.3.2 How are quality objectives defined?
1.A.4 PQS tools
1.A.5 Knowledge management
1.A.5.1 Change management – an example
1.A.5.2 Deviation management – an example
1.A.6 Practical implementation of the PQS
Summary
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