Checklist for Implementation of GDP Principles - Part 5: Operations

According to Chapter 5 (Operations) 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 actions taken by wholesale distributors should ensure that the identity of the medicinal product is not lost and that the wholesale distribution of medicinal products is performed according to the information on the outer packaging. The wholesale distributor should use all means available to minimise the risk of falsified medicinal products entering the legal supply chain."

In this regard, the chapter sets out, among other things, requirements for the qualification of suppliers, the qualification of customers as well as for the receipt and storage of medicinal products and the destruction of obsolete goods.

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 5 of the 2013 guidelines:

• All medicinal products distributed in the EU have a marketing authorisation granted by the EU or by a Member State
• For distributors, not being the marketing authorisation holder: the marketing authorisation holder and the competent authority in the Member State to which the medicinal product is imported of his intention is notified of importation
• For products being exported: a wholesale distribution authorisation or a manufacturing authorisation is in place. This is also the case if the exporting wholesale distributor is operation from a free zone.

Supplier Qualification

• All supplies of medicinal products are obtained only from persons/organisations who are in possession of a wholesale distribution authorisation, or who are in possession of a manufacturing authorisation which covers the product in question
• When medicinal product is obtained from another wholesale distributor: compliance with the principles and guidelines of good distribution practices of the supplying wholesale distributor is verified
• When medicinal product is obtained from manufacturer or importer: manufacturer or importer holds a manufacturing authorisation
• When medicinal product is obtained from a broker: broker is registered and complies with the requirements in Chapter 10 of the Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use
• The purchase of medicinal products is controlled by written procedures
• The supply chain of medicinal products is known and documented
• Appropriate qualification is performed prior to any procurement
• Qualification and approval of suppliers is controlled by a standard operating procedure
• The results of qualification and approval of suppliers are documented
• The results of qualification and approval of suppliers are periodically rechecked
• Qualification and approval of new suppliers: A risk based approach is used considering
  - searches for the new supplier’s reputation or reliability and its authorised activities
  - possible target of falsification
  - large offers of medicinal product which are generally only available in limited quantities
  - out of range prices

Qualification of Customers

• Medicinal products are only supplied to persons/organisations who are themselves in possession of a distribution authorisation or who are authorized or entitled to supply medicinal products to the public
• Qualification of customers and periodic rechecks include:
  - requesting copies of customer's authorisations
  - verifying status on an authority website
  - requesting evidence of qualifications or entitlement according to national legislation.
• Qualification of customers are appropriately documented

Receipt of Goods

• When receiving medicinal products from third countries for the purpose of importation: manufacturing/import authorisation is in place
• It is ensured that that the arriving consignment is correct, the medicinal products originate from approved suppliers and have not been damaged or altered during transportation
• Medicinal products which require special storage or security measures, are transferred to appropriate storage facilities immediately after appropriate checks have been conducted
• In the event of any suspicion of falsified medicinal product, the batch is immediately segregated
• In the event of any suspicion of falsified medicinal product, the batch is immediately reported to the national competent authority
• In the event of any suspicion of falsified medicinal product, the batch is immediately reported to the marketing authorisation holder (where applicable)
• Batches of medicinal products intended for the Union market are only transferred to saleable stock before assurance has been obtained that they are authorised and released for sale for the market in question
• Incoming containers of medicinal products are cleaned, if necessary, before storage

Storage

• Medicinal products are stored separately from other products
• Medicinal products are protected from harmful effects of light, temperature, moisture or other external factors.
• Particular attention is paid to products where specific storage conditions are required
• Stock rotation according to the expiry dates of batches of medicinal products is performed ("first expired first out" FEFO basis.)
• Medicinal products beyond their expiry date or shelf life are withdrawn immediately from saleable stock either physically or through other equivalent electronic segregation
• Physical removal of unsuitable stock is performed regularly
• Medicinal products are not stored directly on the floor
• Stock inventories are performed regularly (timings are defined using a risk based approach)
• Inventory irregularities are investigated and documented

Segregation of Goods

• Segregation is provided for the storage of rejected, expired, recalled or returned products and suspected falsified medicinal products
• Any system replacing physical segregation such as electronic segregation based on a computerised system provides equivalent security and is validated

Destruction of obsolete Goods

• Medicinal products intended to be destroyed are kept separately and handled in accordance with a written procedure
• Destruction of medicinal products is in accordance with national or international requirements for disposal of such products
• Records of all destroyed medicinal products are maintained

Picking and packing

• Controls are in place to ensure the correct product is picked
• Products have an appropriate remaining shelf life when picked
• Products are picked on a "first expired first out" (FEFO) basis
• Packing is adequate to maintain the storage conditions of the product during transport

Export (exceptions)

• The rules for wholesale distribution apply in their entirety in the case of export of medicinal products, with the following exceptions:
  - a. The medicinal product does not have to be covered by a marketing authorisation of the EU or a Member State;
  - b. The customer does not have to be holder of a distribution authorisation;
  - c. Moreover, where the medicinal product intended for exportation has been obtained directly from another third country, without the product being prior to that placed on the market (i.e. without prior import), the supplier does not have to bear a wholesale distribution authorisation

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.