GDP: MHRA concerned about Supplier Qualification

Recommendation

28/29 September 2021

Live Online Training: The GDP Compliance Manager

In a recent blog, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) reminds companies to assure their supply chain integrity. The reason for sharing this is that MHRA recently had a number of situations where companies have not understood the respective obligations. There are three steps described to properly qualify suppliers:

• Authorised supplier holds a manufacturing or wholesale dealers licence
• Supplier complies with GDP (GDP certificate available)
• Due diligence checks (including evaluation of on-site audits)

In the first step, it should be verified that supplies of medicinal products only come from entities that are in possession of a wholesale distribution authorisation or a manufacturing authorisation which covers the product in question. The information can also be verified by using the EudraGMDP website. But currently the EudraGMDP database does not contain complete information. The best way to demonstrate possession of a license could be an official copy of the appropriate pages.

The next step requires a verification that the supplier complies with the principles and guidelines of good distribution practices. Here, the EudraGMDP website can be used to check the GDP certificate. If there is no GDP certificate available, other evidence should be obtained.

The third step is (periodic) rechecking of the information obtained. The MHRA recommends performing documented checks at least twice a month of MHRA's list of suspended licence holders and regular checks on EudraGMDP website for issued GMP and GDP statements of non-compliance.

For new suppliers, it is recommended to carry out 'due diligence' checks. The suitability, competence and reliability of the other party should be thoroughly assessed including on-site audits and the check of the financial status.

Here you will get to the recent MHRA blog.