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ISPE Good Practice Guide: Clinical Supply Systems cover image

ISPE Good Practice Guide: Clinical Supply Systems

Published:March 2014

Pages:118

Currently there are no standards or guidelines for system functionality that manage Investigational Medicinal Products (IMPs). Lack of standards for data and functionality has resulted in varying terminology, data formats, and controls which can often make the selection, use, or interfacing of systems challenging.

The ISPE Good Practice Guide: Clinical Supply Systems provides a detailed discussion of important areas of clinical supply system functionality, touching on key business requirements to assist interested parties with developing customized clinical supply applications or assessing commercial off the shelf systems for implementation. Examples and requirements for interfacing clinical supply systems involved in the management of IMPs with other internal or external systems are provided.

The Guide also contains a list of proposed standard data terminology, along with frequently used equivalent terms, definitions of the data terms, and data formatting standards.

This Guide is intended to be useful for persons with a foundational background in clinical supplies, who are involved in evaluating or designing clinical supply systems which meet operational, quality and regulatory requirements.

This Guide may also be useful to personnel in smaller biopharmaceutical organizations to assess the systems that their suppliers use to support the clinical supply services they provide.

This Guide also aims to help companies adopt common data standards to make working across company boundaries more seamless.

  • 1 Introduction
  • 1.1 Background
  • 1.2 Scope
  • 1.3 Key Concepts/Terms
  • 2 Data Standards
  • 2.1 Introduction
  • 2.2 Metadata
  • 3 Functionality and Design Considerations
  • 3.1 Material Requirements Planning
  • 3.1.1 Independent Demand and Dependent Demand
  • 3.1.2 Demand Forecasting for Kits
  • 3.1.3 Planning for Kits at a Distribution Center
  • 3.1.4 Planning for Kits at the Packaging Facility
  • 3.1.5 Planning for Drug Products at the Drug Products Manufacturing Facility
  • 3.2 Drug Product BOMs/Material Masters
  • 3.2.1 Drug Product Material Masters
  • 3.2.2 Bill of Materials
  • 3.2.3 Single Level BOM
  • 3.2.4 Multi-Level BOM
  • 3.2.5 Equivalent Materials
  • 3.3 Packaging BOMs/Material Masters
  • 3.3.1 Packaging Material Masters
  • 3.3.2 Bill of Materials
  • 3.3.3 Single Level BOM
  • 3.3.4 Multi-Level BOM
  • 3.3.5 Equivalent Materials
  • 3.3.6 How BOMs Are Used
  • 3.4 Inventory Management
  • 3.4.1 Receiving
  • 3.4.2 Fulfillment of a Drug Product Manufacturing Execution or Packaging Execution
  • 3.4.3 Material Movement
  • 3.4.4 Adjustment
  • 3.4.5 Restock/Reorder Point Notification
  • 3.4.6 Retest Notification
  • 3.4.7 Material Allocation
  • 3.4.8 Material Reservation
  • 3.4.9 Viewing Material
  • 3.5 Drug Product Manufacturing Execution
  • 3.5.1 Request for Manufacture
  • 3.5.2 Fulfillment
  • 3.6 Lot Genealogy
  • 3.7 Kit Identification
  • 3.7.1 Description on Label: Blind or Open
  • 3.7.2 Serialization on Label: Unique Kit ID, Subject ID/Visit ID, or No ID
  • 3.7.3 System Requirements for Kit Identifiers
  • 3.8 Subject Randomization
  • 3.8.1 Static Subject Randomization
  • 3.8.2 Adaptive (Dynamic) Subject Randomization
  • 3.8.3 System Requirements for Packaging and Labeling Systems
  • 3.8.4 System Requirements for IRT Systems
  • 3.9 Kit Lists (Randomized or Sequential)
  • 3.10 Blinding Controls
  • 3.10.1 Data Elements to Mask (Blinded Users)
  • 3.10.2 Protocol Access
  • 3.11 Labels (Translations, Design, and Printing)
  • 3.11.1 Introduction
  • 3.12 Label Phrase Translations (Including Approval and Controls)
  • 3.12.1 Label Design (Including Approval)
  • 3.12.2 Label Printing
  • 3.13 Packaging Request
  • 3.14 Packaging Work Orders and Execution
  • 3.14.1 Creating Packaging Work Orders
  • 3.14.2 Executing Packaging Work Orders
  • 3.15 Drug Product and Finished Goods Dating
  • 3.16 Regulatory and Quality Controls for Investigational Medicinal Products
  • 3.16.1 cGMP (QA) Approvals and Controls for Investigational Medicinal Products
  • 3.16.2 Country Specific Regulatory Release of IMP
  • 3.16.3 Qualified Person (QP) Certification and Release of IMP
  • 3.16.4 Summary of Quality (cGMP, QP) and Regulatory Controls
  • 3.17 Samples
  • 3.18 Investigator Ethical Approval and Controls
  • 3.19 Distribution Network Configuration
  • 3.19.1 Transactions between Facilities
  • 3.19.2 Distribution Transaction Types
  • 3.19.3 Network Location Properties/Settings
  • 3.19.4 Network Configuration Business Rules
  • 3.19.5 Distribution Channels
  • 3.20 Shipment Requests and Orders
  • 3.20.1 Purpose
  • 3.20.2 Order Numbering
  • 3.20.3 Header Information
  • 3.20.4 Order Details Numbered Material
  • 3.20.5 Order Details Non-Numbered Material
  • 3.20.6 Integrating with Other Systems
  • 3.21 Shipment Pick/Pack/Ship
  • 3.21.1 Documentation
  • 3.21.2 Barcode Scanning
  • 3.21.3 Shipping Container identification
  • 3.21.4 Interfaces with Courier Systems
  • 3.21.5 Interfaces with Warehouse Management Systems
  • 3.21.6 Pick/Pack/Ship System Requirements
  • 3.22 Controlled Temperature Management of Clinical Supplies
  • 3.22.1 History
  • 3.22.2 Importance of Temperature Control Effectiveness
  • 3.22.3 Considerations for Managing Temperature Sensitive Operations
  • 3.23 Shipment Invoice/Content
  • 3.24 Shipment Tracking
  • 3.25 Alignment with GAMP
  • 3.26 Managing Non-IRT Studies
  • 3.26.1 Creating the Shipment Request
  • 3.26.2 Tracking the Proof of Receipt
  • 3.26.3 Replenishment at the Clinical Site
  • 4 System Interfaces and Considerations
  • 4.1 Clinical Supply System and Clinical Trial Management Systems
  • 4.1.1 Demand Forecasting for Kits
  • 4.1.2 Distribution and IRT Systems
  • 4.2 Clinical Supply System and Supplier IRT System
  • 4.3 Clinical Supply System and Courier Systems
  • 4.4 IRT System and External Distribution System
  • 4.4.1 Shipment to Distribution Centers
  • 4.4.2 Shipment from Distribution Centers to Sites
  • 4.4.3 Inventory Adjustments
  • 4.5 Clinical Supply System and Laboratory Information Management System
  • 5 Appendix 1 – Data Standards Information
  • 6 Appendix 2 – Common EDI Data Elements
  • 7 Appendix 3 – References
  • 8 Appendix 4 – Glossary
  • 8.1 Acronyms
  • 8.2 Definitions
  • Petra Bielmeier, F. Hoffmann-La Roche AG, Switzerland
  • Anurag Gautam, Eli Lilly & Co., USA
  • Matthew Gilson, GlaxoSmithKline, USA
  • Henryk Junker, Allergan Ltd., United Kingdom
  • Douglas Meyer, Biogen Idec, USA
  • Greg Minogue, Fisher Clinical Systems, USA
  • Eddie Montoya, Fisher Clinical Systems, USA
  • David Riege (Lead), Pfizer Inc., USA
  • Sandee Schroeder, AbbVie Inc., USA
  • Andrew Scott, Almac Clinical Services, United Kingdom
  • Jeff Young, AbbVie Inc., USA

Many biopharmaceutical organizations have numerous internal systems that are used to manage and control clinical studies and investigational medicinal products, or use third party providers to perform at least some of their investigational medicinal product management activities. Currently, there are no standards or guidelines for system functionality that manage investigational medicinal products.

Lack of standards for data and functionality has resulted in varying terminology, data formats, and controls which can often make the selection, use, and/or interfacing of systems challenging. This Guide, the ISPE Good Practice Guide (GPG): Clinical Supply Systems, contains a list of proposed standard data terminology along with frequently used equivalent terms, definitions of the data terms, and data formatting standards.

The Guide also provides a detailed discussion of important areas of clinical supply system functionality touching on key business requirements to assist interested parties in developing customized clinical supply applications or assessing commercial off the shelf systems for implementation. The Guide provides examples and requirements for interfacing clinical supply systems involved in the management of investigational medicinal products with other internal or external systems.