EC Guidelines on Good Distribution Practice of Medicinal Products for Human Use 2013 v2, 11/13
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In November, 2013 the EU Commission published Guidelines on Good Distribution Practice of Medicinal Products for Human Use. This replaces the GDP directive from March, 2013.
Please see the following sections for computer-related details:
- Section 3.2 (Premises) requires validation and security for computer systems used to segregate product
- Section 3.3.1 (Computerised Systems) requires system validation or verification prior to use, up-to-date system documentation, security, back-ups, data retention, and procedures for addressing system failures.
| Issuing Body | European Commission |
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