Checklist for Implementation of GDP Principles - Part 6: Complaints, Returns, suspected falsified Medicinal Products and Medicinal Product Recalls

According to Chapter 6 (Complaints, Returns, suspected falsified Medicinal Products and Medicinal Product Recalls) of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01) "all complaints, returns, suspected falsified medicinal products and recalls must be recorded and handled carefully according to written procedures. [...] A consistent approach by all partners in the supply chain is required in order to be successful in the fight against falsified medicinal products."

A major requirement is to immediately inform the competent authority and the marketing authorisation holder of any medicinal products identified as falsified or suspected to be falsified. A procedure should be in place to cover this activity, including the recording of the relevant investigation.

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 6 of the 2013 guidelines:

Complaints

• A written procedure is in place for the handling of complaints
• Distinction is made between complaints about the quality of a medicinal product and those relating to distribution
• In the case of a complaint about the quality of a medicinal product, the manufacturer and/or marketing authorisation holder is informed without delay.
• A person is appointed for handling the complaints with sufficient supporting personnel
• Any complaint concerning a potential product defect or a potential falsified product is recorded with all the original details and investigated
• The national competent authority is notified without delay in case of a potential product defect or a potential falsified product
• Any product distribution complaint is thoroughly investigated
• Appropriate followup actions are taken after investigation and evaluation of the complaint

Returned Medicinal Products

• Written procedures are in place for the handling and acceptance of returned medicinal products
• Medicinal products which have left the premises of the distributor are only returned to saleable stock if:
  - the medicinal products are in their unopened and undamaged secondary packaging and in good condition
  - medicinal products returns from a customer not holding a wholesale distribution are returned within five days, or as specified in national legislation, of original dispatch
  - it is demonstrated that the medicinal products have been transported, stored and handled under proper specified/predefined conditions
  - they have been examined and assessed by a sufficiently trained and competent person authorised to do so
  - the distributor has reasonable evidence that the product was supplied to that customer
  - the batch number of the dispatched product is known
  - a copy of the original delivery note is attached
  - there is no reason to believe that the product has been falsified
  - there is evidence that the product has been stored within the authorised storage conditions throughout the entire time
• A Risk Assessment is performed taking into account
  - the product concerned
  - any specific storage requirements
  - the time elapsed since the medicinal product was originally dispatched
• Returned medicinal products are kept segregated from saleable stock until a decision is taken regarding their disposition by the RP
• Returned medicinal products requiring specific temperature storage conditions such as low temperature are accompanied by documented evidence that the product has been stored under the authorised storage conditions throughout the entire time
• Products returned to saleable stock are placed that the "first expired first out" (FEFO) system operates effectively
• All handling of returned medicinal products including their return to saleable stock or disposal are approved by the Responsible Person and recorded

Suspected falsified Medicinal Products

• The staff are aware of the risks of falsified medicinal products entering the supply chain
• A procedure is in place describing immediate information of the competent authority (and, where applicable, the marketing authorisation holder of the medicinal products they identify as falsified or suspect to be falsified
• Any suspected falsified medicinal products found in the supply chain is immediately physically and securely segregated from legitimate medicinal products
• All relevant activities are recorded
• All documents and all records are retained and retrievable

Medicinal Product Recalls

• There is a written procedure for the management of recalls
• The management of recalls and its effectiveness is periodically tested and evaluated (Mock Recall)
• Any recall operation is recorded at the time it is carried out
• The distribution records are readily available to the person(s) responsible for the recall
• The records contain information on
  - Distributors and Directly Supplied Customers, with
     Addresses
     Phone and/or fax numbers during inside and outside of working hours
     Email addresses
     Batch numbers at least for products bearing safety features as required by legislation
     Quantities
  - The records include those for
     Exported Products
     Medicinal Product Samples
• The progress of a recall process is recorded and a final report issued (including reconciliation between the delivered and recovered quantities of the medicinal products)

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.