GDP-Inspector: Why Supplier Qualification is important

Recommendation

23/24 February 2021

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Peter Brown, GDP Inspector at the U.K. Medicines and Health Regulatory Agency MHRA, explains in a Blog what qualification of suppliers means.

In the recent GDP inspection history, the MHRA noted several issues within the supply of products, for example "criminal attempts to sell falsified and stolen stock into the legitimate supply chain by a variety of methods".

Peter Brown reports about stealing identities of legitimate companies, persons setting up cloned or fake e-mail addresses and even fake websites. Even more difficult to detect are cases where companies and their wholesale dealer licences have been purchased and then falsified medicines was supplied to customers.

How can supplier qualification help?

The MHRA points out that it is of utmost importance not only to rely on information provided by the supplier:

• Contact details should be validated
• Types, volumes and prices of products being offered should be reasonable
• Significant changes in directorship or ownership should be considered and evaluated
• Approved and valid e-mail addresses should be used
• Licences should be checked for legitimacy

The MHRA at least expects that licence holders "have appropriate systems to safeguard the supply chain" including appropriate risk assessments and transparent documentation.

Source: MHRA Inspectorate Blog "What does qualification of suppliers mean to you? Risks to patients and to your business"