Tuesday, 30 April 2024 9 .30 - 16.45 h
Chapter 4 (Documentation) of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01) points out that "good documentation constitutes an essential part of the quality system."
Documentation comprises all written procedures, instructions, contracts, records and data, i.e. all information required to demonstrate the what, by who, when, how and why should be documented in the Quality Management System paying attention to compliance to Data Integrity, Data Management and Data Retention.
The following checklist provides a generic overview and could be used as a minimum requirement related to Chapter 4 of the 2013 guidelines:
SOPs
Records
The points listed above are an excerpt from the "ECA Roadmap to Good Distribution Practice (GDP)", which includes checklists to verify the minimum implementation of GDP, based on the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01). The European GDP Association (GDPA) has compiled this document to support pharmaceutical and wholesaler businesses in implementing regulatory requirements and expectations in their quality systems. The PDF is available for download free of charge in the GDPA members' area.