Qualification of Suppliers - What needs to be considered?

Recommendation

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Wholesale distributors must verify their suppliers are authorised to supply medicinal products.

Legal Background

According to chapter 5.2. of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01), the following applies:

Wholesale distributors must obtain their supplies of medicinal products only from persons who are themselves in possession of a wholesale distribution authorisation, or who are in possession of a manufacturing authorisation which covers the product in question.

Wholesale distributors receiving medicinal products from third countries for the purpose of importation, i.e. for the purpose of placing these products on the EU market, must hold a manufacturing authorisation.

Where medicinal products are obtained from another wholesale distributor, the receiving wholesale distributor, must verify that the supplier complies with the principles and guidelines of good distribution practices and that they hold an authorisation for example by using the Union database. If the medicinal product is obtained through brokering, the wholesale distributor must verify that the broker is registered and complies with the requirements in Chapter 10.

Appropriate qualification and approval of suppliers, should be performed prior to any procurement of medicinal products. This should be controlled by a procedure and the results documented and periodically rechecked.

When entering into a new contract with new suppliers, the wholesale distributor should carry out ‘due diligence’ checks in order to assess the suitability, competence and reliability of the other party. Attention should be paid to:
(i) the reputation or reliability of the supplier;
(ii) offers of medicinal products more likely to be falsified;
(iii) large offers of medicinal products which are generally only available in limited quantities; and
(iv) out-of-range prices.

Rationale for this point

One of the main reasons for the requirements mentioned above is preventing falsified medicine being supplied through authorised channels.

It is also intended to minimise the risks of products not being stored and transported to appropriate GDP standards. This is to protect patients, as incorrect storage and transport may have negative impacting on the quality of medicinal products.

Implementation

The following points should be considered:

• The qualification should be performed prior to any procurement activities;
• The selection, qualification and approval of suppliers should be defined in a Standard Operating Procedure (SOP);
• The initial supplier approval should include appropriate ‘due diligence’ checks;
• Appropriate technical/quality agreements should be put in place;
• There should be periodic rechecks because authorisations may change over time;
• Requalification should be performed according to a risk based approach;
• The whole process should be documented;
• Documents should be kept and should be easily available in case of regulatory inspections or audits.

How to Check if a Supplier has a Wholesale Distributor Authorisations (WDA)

The use of the EudraGMDP database is recommended. Within the European Union, Wholesale Distribution Authorisations (WDA) are issued by the national competent authority of the member state in which the wholesale distributor operates. The member states shall enter the certificates of good distribution practices which they issue in the EudraGMDP. This database is maintained and operated by the European Medicines Agency (EMA). If an inspection shows that the wholesaler's GDP compliance cannot be confirmed, a so-called GDP non-compliance report is issued.

In addition to using the EudraGMDP database, the supplier should be asked to send a copy of their authorisation.