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Unlocking the mystery: deciphering the differences between GDP vs GMP and WDA vs MIA

GDP versus GMP

For the first topic, let’s unravel the specific activities for GDP versus GMP.

The GDP guidelines for medicinal products 2013/C 343/01 (human) and REGULATION (EU) 2021/1248 (veterinary) describe activities such as requirements for Quality Management, Personnel, Premises and Equipment, Documentation, Operations (Production in GMP), Complaints & recalls, Outsourcing and Self-inspections, which are overlapping with GMP activities. GDP specific activities are Falsification & returns, Transport, Brokerage and Supplier & customer qualification (part of “Operations” chapter).

EudraLex Volume 4 contains the GMP guidelines for medicinal products. GMP specific activities are described in chapter 5 “Production” and in chapter 1 “Pharmaceutical Quality System”, the latter mentioning specific activities as Quality Control of the products (testing and sampling), and Product Quality Review (annual as per industry standard).

WDA versus MIA

Now, for the second topic, let us explain the essential difference between a WDA and a MIA, without going too much into detail!

A Wholesale Distribution Authorization (WDA) is a regulatory approval that allows a wholesale distributor to purchase, supply, store and export pharmaceuticals (not to the public) in a country from where the pharmaceuticals will be distributed to the customers.
A WDA holder needs to comply with GDP requirements as per EU legislation.
A responsible person (RP) ensures that an organisation is compliant to the GDP requirements, translated in a wide range of tasks and responsibilities.

A Manufacturing and Importer Authorization (MIA) is a regulatory approval that allows a manufacturer or importer to produce (incl labelling, packaging, testing & release) or import pharmaceuticals into a country.
A MIA holder needs to comply with GMP requirements as per EU legislation.
A qualified person (QP) ensures that each batch of medicinal product has been manufactured according to GMP guidelines and is checked in compliance with the specifications of the Marketing Authorization.

In conclusion, MIA vs WDA, GMP vs GDP are clearly having differences, and all of it is activity related.

Now we have written down the differences above, it’s easier to keep in mind those differences when implementing GMP or GDP quality systems. So, let’s get started!