Sourcing and distribution of pharmaceutical materials and products are critical activities in any integrated supply chain. In the pharmaceutical arena, this involves packaging materials, active pharmaceutical ingredients, excipients, and final products such as pharmaceuticals, medical devices, and combination products.
With the globalization of the pharmaceutical industry, various individuals and organizations from locations around the world are responsible for the handling, storage, and distribution of these products. Thus, it is critical to have adequate control over the entire supply chain—ranging from material procurement to manufacturing to delivery of a final product to the patient.
To maintain the quality of materials or products, every party involved in the supply chain should understand and comply with the applicable requirements. Each activity in the distribution of a material or product should be carried out according to the principle of Good Distribution Practices (GDP).
In 2015, five new general chapter standards related to GDP are scheduled to become official in the United States Pharmacopeia—National Formulary (USP–NF).
The U.S. Pharmacopeial Convention (USP) develops standards related to the quality of drugs and their ingredients. Its compendia—USP–NF—includes monographs, general chapters, and General Notices. While USP develops standards, enforcement of these standards is the responsibility of the U.S. FDA and other government authorities in the U.S. and elsewhere.
USP general chapters are numbered either below or above 1000. Chapters designated above 1000 are intended to be informational, and contain no mandatory requirements unless specifically referenced in a monograph, General Notices or a general chapter numbered below 1000.
The first of USP’s GDP-related general chapters—all of which are designated above 1000 and not called out for application in any monographs—is General Chapter <1083> Good Distribution Practices, which provides an overarching view of GDP concepts and lays the foundation for the subsequent chapters in this series.
The remaining four general chapters cover material flow beginning with initial procurement, continuing throughout the supply chain to delivery to the end user for pharmaceutical components and products, medical devices, and dietary supplements. These chapters are <1083.1> Quality Management Systems, <1083.2> Environmental Conditions Management, <1083.3> Good Importation and Exportation Practices, and <1083.4> Supply Chain Integrity and Security. USP is receiving comments to these chapters and is open to discussion of these proposals in a continuous manner.
In 2015, USP will propose three more general chapters as part of its series on GDP standards. These will cover clinical trial drugs, excipients, and final drug products. The proposed chapters will be posted on Pharmacopeial Forum for public comment, and USP encourages all stakeholders interested in GDP standards—including those involved in packaging, storage, and distribution of products—to provide feedback.