Part 1 in our series on pharmaceutical distribution outlined a big picture overview of the current (but ever-changing) model of the pharma cold chain. In this post, we dive further into the Good Distribution Practices (GDPs) recommended to guarantee supply chain safety and security of medications as they move from manufacturer to patient. Because prescription drugs have become more expensive and specialized, the federal government has passed more stringent regulations and mandated increased FDA oversight. In this climate of public scrutiny, GDP is essential at every link in the pharmaceutical supply chain.
The Drug Supply Chain Security Act (DSCSA) was a major advance in improving safety and security in pharmaceutical distribution. Establishing a single, digital, national solution, it outlines steps to identify and trace prescription medications during nationwide distribution. The DSCSA also improves detection and elimination of unsafe drugs from the supply chain to protect consumers.
The FDA plays the primary role in defining and enforcing the law’s regulations. The agency’s role is to:
Along with the federal requirements of the DSCSA, the World Health Organization (WHO) has recommended detailed Good Distribution Practices of pharmaceutical products that can be adopted and adapted by any country, including the U.S.
The goal of the GDPs is to help ensure the quality and identity of pharmaceutical products during all aspects of supply chain monitoring: procurement, purchasing, storage, distribution, transportation, repackaging, relabeling, documentation and record-keeping. The following principles of the WHO GDP apply to pharmaceutical products moving forward in the supply chain from the manufacturer to the patient, as well as moving backward as the result of a recall.
Each stakeholder in the supply chain should create and document a Quality System (QS) outlining the overall requirements of their role. The QS should include the procedures, resources and actions necessary to ensure adequate confidence that a product satisfies all given requirements for quality and safety. Inspection, auditing, risk assessments, and certification of compliance with the International Standardization Organization (ISO) by third parties is also recommended to maintain quality and to address new potential threats.
To foster a safe and secure supply chain, transparency procedures must be put in place in ensure traceability of all drugs transported and received along the supply chain. These measures require detailed, recorded documentation that can be used throughout all distribution channels to locate the point of origin responsible for supplying an unsafe drug at risk of patient administration. By increasing traceability, the recall process becomes more efficient and effective.
At every level of the supply chain, employees should be fully informed and trained in clearly defined duties to ensure product safety. A designated manager should be appointed with the authority and responsibility for implementing and maintaining a Quality System.
Methods of transportation should be selected with care. Local conditions must be accommodated, including the climate and any seasonal variations. Delivery schedules should be established and routes planned, taking local needs and conditions into account. Care should be taken to ensure that the volume of pharmaceutical products ordered does not exceed the capacity of storage facilities at the destination. Finally, procedures should be put in place to ensure that:
Next up in part 3: we’ll take a close look at vaccine distribution to understand the importance of temperature monitoring to drug safety along the pharma supply chain.
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