Checklist for Implementation of GDP Principles - Part 7: Outsourced Activities

According to Chapter 7 (Outsourced Activities) of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01) "any activity covered by the GDP guide that is outsourced should be correctly defined, agreed and controlled in order to avoid misunderstandings which could affect the integrity of the product."

The Chapter clearly defines the roles and responsibilities of the Contract Giver and the Contract Acceptor and states the need for a detailed contract to cover the outsourced activity.

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 7 of the 2013 guidelines:

• Contracts are in place for any GDP-related activity, covering all wholesale distribution activities and clearly establish the duties and responsibilities of each party
• Contract acceptor holds a distribution authorisation as relevant where activities require a Competent Authority authorisation
• Where required, the Contract Acceptor has adequate
  - Premises
  - Equipment
  - Procedures
  - Knowledge and Experience
  - Competent personnel to carry out the work ordered by the Contract Giver
• An audit of the Contract Acceptor is performed before the beginning of the outsourced activities
• A Technical Quality Agreement is established and agreed between the Contract Giver and Contract Acceptor prior to commencing the outsourced activity
• The Contract and Technical Quality Agreement lay out the requirement for the Contract Giver to notify the Contract Acceptor prior to further outsourcing any activities
• Where activities are further subcontracted the Contract Acceptor has made appropriate arrangements with their third party to ensure the wholesale distribution information is made available in the same way as between the original Contract Giver and Contract Acceptor
• After the beginning of the outsourced activities audits are performed periodically
• Audits are performed where there is a change to the outsourced activities
• The Contract Giver has provided all relevant information to the Contract Acceptor to enable the contracted activities to be carried out in accordance with the specific product requirements and any other relevant requirements

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.