as of 2019 - 12 - 10
16 Storage and Transportation
Summary:
16.A.2 Personnel
16.A.3 Controlling material handling
16.A.4 Storage organisation
16.A.4.1 Controlling the release status
16.A.4.2 Controlling expiry dates
Summary:
16.B.6.2 Printed packaging materials
Summary:
16.C.2 Hygiene
16.C.3 Pest control
Summary:
Summary
16.E.2 What is the significance of humidity for cold-storage medicinal products?
16.E.3 Regulatory requirements for the qualification of storage facilities
16.E.4 Case study: Qualification of a new cold-storage facility
16.E.5 Organisational requirements for a successful qualification
16.E.6 Documenting the qualification
16.E.7 Qualification in accordance with the V-Model
16.E.7.1 Risk analysis (RA)
16.E.7.2 User Requirements Specification (URS)
16.E.7.3 Functional Design Specification (FDS)
16.E.7.4 Design qualification (DQ)
16.E.7.5 Site Acceptance Test (SAT)
16.E.7.6 Installation qualification (IQ)
16.E.7.7 Operational qualification (OQ)
16.E.7.8 Performance qualification (PQ)
16.E.8 Maintaining the qualified state
16.E.8.1 Maintenance
16.E.8.2 Change management
16.E.8.3 Deviation management
16.E.8.4 Requalification
16.E.9 Qualification of an existing cold-storage facility
16.E.9.1 Qualification stages and their content
16.E.9.2 Risk analysis
16.E.9.3 Temperature mapping
16.E.9.4 Requalification
16.E.10 Tests that are relevant to the qualification
16.E.10.1 Testing redundancy and the alarm system
16.E.10.2 Temperature mapping
16.E.11 Monitoring system
Summary:
16.F.2 Short description of the storage facility for standard storage at 15–25 °C
16.F.3 Storage conditions for standard medicinal products: what do the regulations say?
16.F.3.1 ICH, EMA and WHO guidelines
16.F.3.2 GDP guidelines
16.F.3.3 European Pharmacopoeia
16.F.4 What is the point of "heating" medicinal products to 15–25 °C?
16.F.5 Risk assessment
16.F.5.1 What are the risks of storage at xx °C–25 °C instead of 15–25 °C?
16.F.5.2 The purpose and nature of the risk assessment
16.F.5.3 Implementation and the results
16.F.6 Monitoring the temperature and humidity
16.F.6.1 Evaluation of previous data
16.F.6.2 Dropping the lower temperature limit
16.F.6.3 Carrying out mapping to determine the coldest/hottest spots
16.F.7 Conclusion
16.F.8 Storage at 9–25 °C: Practical implementation
16.F.9 Conclusion and outlook
Summary:
16.H.1 Germany and Austria
16.H.1.1 AMWHV and AMBO
16.H.1.2 Ordinance on the Trade with Medicinal Products (AM-HandelsV)
16.H.2 Europe
16.H.2.1 Guidelines on Good Distribution Practice of Medicinal Products for Human Use (EU GDP Guideline for Medicinal Products)
16.H.2.2 Guidelines on Principles of Good Distribution Practice of Active Substances for Medicinal Products for Human Use (EU GDP Guidelines for active substances)
16.H.2.3 EU GMP Guidelines
16.H.3 USA and Canada
16.H.3.1 USP Monograph <1079> Good Storage and Distribution Practices for Drug Products
16.H.3.2 USP-Monograph <659> Packaging and Storage Requirements
16.H.3.3 Health Canada Guideline
16.H.4 WHO Guidelines
16.H.4.1 Good Distribution Practice (GDP)
16.H.4.2 Good Storage Practice (GSP)
16.H.5 PDA Documents
16.H.5.1 PDA – Technical Report No. 39
16.H.5.2 PDA Technical Report No. 46
16.H.5.3 PDA Technical Report No. 58
16.H.5.4 PDA Technical Report No. 72
16.H.6 Outlook
16.I Transport conditions
Summary:
16.I.1 Transport as mobile storage
16.I.2 Storage conditions
16.I.3 Transport at ambient temperature
16.I.4 Refrigerated transport of cold-storage products and the cold chain
16.I.5 Frozen transport
16.J Transport vehicles and shipping containers
Summary
16.J.1 Transport vehicles with active temperature control
16.J.2 Shipping containers with active temperature control
16.J.2.1 Conventional air-freight containers
16.J.2.2 Active-cooling containers
16.J.2.3 Active heat & cool container
16.J.3 Passive transport packaging
16.J.3.1 Boxes with cool packs
16.J.3.2 Thermal boxes
16.J.3.3 Insulated boxes
16.K Modes of transportation
Summary
16.K.1 Guidelines and quality standards for road transport
16.K.1.1 HACCP
16.K.1.2 ATP
16.K.2 Guidelines and quality standards for air transportation
16.K.2.1 IATA Guidelines
16.L Monitoring
Summary:
16.L.1 Temperature monitoring during transport
16.L.2 Temperature loggers
16.L.3 RFID technology
16.L.4 Telematics
16.L.4.1 Locating function
16.L.4.2 Vehicle data
16.L.4.3 Temperature data
16.L.4.4 Personnel management
16.L.4.5 Communications management
16.L.4.6 Other features
16.L.4.7 Trends
16.L.5 Alarm system
16.M Risk management in transportation
Summary:
16.M.1 Risk-based approach
16.M.2 Risk assessment
16.M.2.1 What risks occur during transport?
16.M.2.2 Analysis and evaluation of risks in the transport chain
16.M.3 Risk control
16.M.4 Risk review
16.N Qualification of large-scale active systems (trailers)
Summary:
16.N.1 Regulatory requirements
16.N.2 The PDA qualification concept
16.N.2.1 Step 1: Requirements profile
16.N.2.2 Step 2: Qualification plan
16.N.2.3 Step 3: Implementation
16.N.3 Qualification acc. to DIN Spec 91323
16.N.3.1 Purpose
16.N.3.2 Field of application
16.N.3.3 Vehicle categories
16.N.3.4 Test conditions
16.N.3.5 Test schedule and acceptance criteria
16.N.4 Special case: 2-temp vehicles
16.O Qualification of passive insulation boxes
Summary:
16.O.1 Process of qualification
16.O.2 Evaluation and performance criteria
16.O.2.1 Insulating material
16.O.2.2 Positioning of cooling elements
16.O.2.3 Quantity of cooling energy
16.O.2.4 Pre-conditioning of cold packs
16.O.2.5 External dimensions
16.O.2.6 Test records and inspection protocols
16.O.2.7 Green Logistics
16.O.2.8 Unit price
16.O.3 Temperature profiles and testing scenarios
16.O.3.1 Basic test of temperature holding capacity acc. to DIN 55545
16.O.3.2 A classic case: WHO Cold Life und Warm Life Test
16.O.3.3 ISTA profiles
16.O.3.4 Association Française de Normalisation (AFNOR)
16.O.3.5 Evaluating the different profiles
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
16.Q Transport validation
Summary:
16.Q.1 Validation or verification?
16.Q.2 Verification of refrigerated transport
16.Q.2.1 Shipping by vehicles with active cooling
16.Q.2.2 Shipment with passive cooling (insulated boxes)
16.Q.2.3 Suitability of shipment types and their aptness for verification
16.Q.3 Verification of a global transport chain
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
Summary
16.S.1 Introduction
16.S.2 Frequent deficiencies in the qualification of logistics service providers and how to avoid them
16.S.2.1 Underdeveloped risk management
16.S.2.2 Inadequate SOP for qualification
16.S.2.3 Incomplete initial qualification
16.S.2.4 Inadequate qualification of commissioned third parties
16.S.2.5 Inadequate consideration of transport
16.S.2.6 Inappropriate interval for requalification
16.S.2.7 Insufficient transparency
16.S.2.8 Inadequate SOP for auditing
16.S.2.9 Unfounded partial audits
16.S.2.10 Inadequate action taken
16.T References
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