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The Impact of the GDP Guidelines on Design, Qualification and Validation of Packaging Systems

Drugs can be damaged by adverse external exposures and thus lose efficacy or become toxic, even deadly. A key area that affects drugs is temperature exposure. Temperature-related damage to drugs is not readily visible and can occur at any point in the supply chain.  David Walsh of Intelsius reviews the new European Union (EU) Guidelines for Good Distribution Practices (GDP) and explains why they are designed so that a product not just makes it to the doctor’s office or pharmacy but is maintained at the appropriate temperature throughout its journey to ensure its safety and efficacy when it reaches the patient.