1 Quality Management Systems 1 Quality Management Systems
1 Quality Management Systems
2 Personnel 2 Personnel
2 Personnel
3 Premises 3 Premises
3 Premises
4 Facilities and Equipment 4 Facilities and Equipment
4 Facilities and Equipment
5 Pharmaceutical Water 5 Pharmaceutical Water
5 Pharmaceutical Water
6 Qualification 6 Qualification
6 Qualification
7 Process Validation 7 Process Validation
7 Process Validation
8 Cleaning Validation 8 Cleaning Validation
8 Cleaning Validation
9 Computer System Validation 9 Computer System Validation
9 Computer System Validation
10 Hygiene 10 Hygiene
10 Hygiene
11 Production 11 Production
11 Production
12 Sterile Production 12 Sterile Production
12 Sterile Production
13 Packaging 13 Packaging
13 Packaging
14 Laboratory Controls 14 Laboratory Controls
14 Laboratory Controls
15 Documentation 15 Documentation
15 Documentation
16 Storage and Transportation 16 Storage and Transportation
16 Storage and Transportation
16.A Storage 16.A Storage
16.A Storage
16.B Storage areas 16.B Storage areas
16.B Storage areas
16.C Storage conditions 16.C Storage conditions
16.C Storage conditions
16.D Incoming goods 16.D Incoming goods
16.D Incoming goods
16.E Qualification of a cold-storage facility 16.E Qualification of a cold-storage facility
16.E Qualification of a cold-storage facility
16.F Standard storage at 15–25 °C? A case study challenging conventional limits 16.F Standard storage at 15–25 °C? A case study challenging conventional limits
16.F Standard storage at 15–25 °C? A case study challenging conventional limits
16.G The role of transport in ensuring the safety and quality of medicines 16.G The role of transport in ensuring the safety and quality of medicines
16.G The role of transport in ensuring the safety and quality of medicines
16.H Regulatory requirements for the transport of pharmaceuticals 16.H Regulatory requirements for the transport of pharmaceuticals
16.H Regulatory requirements for the transport of pharmaceuticals
16.I Transport conditions 16.I Transport conditions
16.I Transport conditions
16.J Transport vehicles and shipping containers 16.J Transport vehicles and shipping containers
16.J Transport vehicles and shipping containers
16.K Modes of transportation 16.K Modes of transportation
16.K Modes of transportation
16.L Monitoring 16.L Monitoring
16.L Monitoring
16.M Risk management in transportation 16.M Risk management in transportation
16.M Risk management in transportation
16.N Qualification of large-scale active systems (trailers) 16.N Qualification of large-scale active systems (trailers)
16.N Qualification of large-scale active systems (trailers)
16.O Qualification of passive insulation boxes 16.O Qualification of passive insulation boxes
16.O Qualification of passive insulation boxes
16.P Logistics service providers 16.P Logistics service providers
16.P Logistics service providers
16.P.1 Responsibilities of a logistics service provider
16.P.1 Responsibilities of a logistics service provider
16.P.2 Requirements profile of a logistics service provider 16.P.2 Requirements profile of a logistics service provider
16.P.2 Requirements profile of a logistics service provider
16.P.3 Different distribution routes and methods: Critical points, taking cold chain logistics as an example 16.P.3 Different distribution routes and methods: Critical points, taking cold chain logistics as an example
16.P.3 Different distribution routes and methods: Critical points, taking cold chain logistics as an example
16.P.4 Qualification of carriers 16.P.4 Qualification of carriers
16.P.4 Qualification of carriers
16.P.5 Carrier qualification/audit questionnaire
16.P.5 Carrier qualification/audit questionnaire
Summary:
Summary:
16.Q Transport validation 16.Q Transport validation
16.Q Transport validation
16.R GDP Audit Questionnaire for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices
16.R GDP Audit Questionnaire for the Transport and Storage of Medicinal Products for Human Use, Active Substances and Medical Devices
16.S GDP inspections: Frequent deficiencies in the qualification of logistics service providers and how to avoid them 16.S GDP inspections: Frequent deficiencies in the qualification of logistics service providers and how to avoid them
16.S GDP inspections: Frequent deficiencies in the qualification of logistics service providers and how to avoid them
16.T References
16.T References
17 Contractors and Suppliers 17 Contractors and Suppliers
17 Contractors and Suppliers
18 Inspections 18 Inspections
18 Inspections
19 Quality Risk Management 19 Quality Risk Management
19 Quality Risk Management
20 Continual Improvement 20 Continual Improvement
20 Continual Improvement
21 Active Pharmaceutical Ingredients 21 Active Pharmaceutical Ingredients
21 Active Pharmaceutical Ingredients
as of 2019 - 10 - 24

16.P Logistics service providers

16.P Logistics service providers
Here you will find answers to the following questions:
●

What are the responsibilities of a logistics service provider?
●

What requirements profile do these result in?
●

What special concerns must be accounted for in distribution overland by truck, detailed distribution logistics and courier service?
●

How can transport service providers be qualified?
16.P Logistics service providers
Summary:
16.P.1 Responsibilities of a logistics service provider
16.P.2 Requirements profile of a logistics service provider
16.P.2.1 Interfaces
16.P.2.2 Quality management
16.P.2.3 Personnel & training
16.P.2.4 Subcontractors
16.P.2.5 Information management
16.P.3 Different distribution routes and methods: Critical points, taking cold chain logistics as an example
16.P.3.1 Overland by truck
16.P.3.2 Distribution logistics (transport from pharmaceutical wholesaler to pharmacy)
16.P.3.3 Courier service providers
16.P.4 Qualification of carriers
16.P.4.1 Requirements for carriers
16.P.4.2 Truck design and loading requirements
16.P.5 Carrier qualification/audit questionnaire

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