Checklist for Implementation of GDP Principles - Part 4: Documentation

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.

Checklist: Implementation of GDP Principles at Wholesale Distributors

The following checklist provides a generic overview and could be used as a minimum requirement related to Chapter 4 of the 2013 guidelines:

• Documents are retained for a period stated in national legislation but at least 5 years at a separate, secure location

SOPs

• SOPs are reviewed regularly and kept up to date
• SOPs are approved, signed and dated by appropriate authorised persons
• Version control is applied to SOPs
• Superseded SOP versions are archived
• Inadvertent use of the superseded versions is prevented
• Superseded or obsolete SOPs are removed from workstations

Records

• For any transaction in medicinal products received, supplied or brokered, records are kept either in the form of purchase/sales invoices, delivery slips, or on computer or in any other form
• Records include the following information:
  - Date
  - name of the medicinal product
  - quantity received, supplied or brokered
  - name and address of the supplier, broker or consignee, as appropriate
  - batch number where required
• Distribution records contain sufficient information on distributors and directly supplied customers (with addresses, phone and/or fax numbers inside and outside working hours, batches and quantities delivered), including those for exported products and medicinal product samples

Reference

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.