EC Guidelines on Good Distribution Practice for Active Substances, 3/15

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In March, 2015 the EU Commission published Guidelines on the Principles of Good Distribution Practice of Active Substances for Medicinal Products for Human Use. These guidelines provide stand-alone guidance on Good Distribution Practice (GDP) for importers and distributors of active substances.

Please see the following sections for computer-related details:

• Chapter 4 (Documentation) outlines requirements for both paper and electronic documents.
• Chapter 6 (Operations), points 6.3, 6.5, and 6.11 address segregation of damaged, falsified, and expired products via physical or electronic systems.
• Chapter 6 (Operations), point 6.10 notes that Electronic Warehouse Management systems require validation.
• The glossary addresses electronic signature and validation definitions.

This document went into effect in September, 2015.