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 5 Rules of Sensor Placement in Validation/Mapping Applications
In today's global economy, drugs, biotechnology and medical devices are shipped all over the world. To ensure these temperature-sensitive products are stored correctly, new or revised regulations have been developed in many key regions, including China, Europe, and the U.S. A universal practice to satisfy the new Good Distribution Practice (GDP) regulations is to perform mapping studies to qualify storage areas. Two common questions in mapping studies are: 1) where to place sensors, and 2), how many sensors to use. This article discusses five rules to apply when creating a rationale for sensor placement in mapping studies.
Global regulators, including the Food and Drug Administration (FDA), the European Medicines Agency (EMA), China's SFDA, and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) require manufacturers to determine if environmental parameters affect product quality and perform stability testing to determine appropriate product storage specifications. It is the job of facilities managers, supply chain managers, and validation specialists (among others) to help ensure that those storage specifications are met by mapping storage areas. Unfortunately, most regulations offer little guidance on how to perform a mapping study. For example, the location and number of sensors that are needed to qualify a given space are not dictated by the regulations; it is left to manufacturers and distributors to determine adequate sensor placement as part of their quality processes.
New Good Distribution Practice explicitly assigns responsibility for compliance to the entire distribution cycle for pharmaceutical and biotechnology products. This means that a large number of previously unregulated entities must now secure their portion of the cool chain through qualification obtained from mapping studies.
This has created a demand for clear and concise guidance on how to perform mapping studies, and at the forefront of this demand are two common questions: 1) where to place sensors, and 2), how many sensors to use.
We developed the "5 Rules of Senor Placement." These rules can guide a mapping practitioner to a reasoned rationale for sensor placement in mapping studies, and supply much needed guidance in this basic and critical validation activity.
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United States of America
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