QP: qualified person

Articles 48 to 52 of Directive 2001/83/EC require every holder of a manufacturing and importation authorisation to have permanently and continuously at its disposal at least one qualified person. Article 49 sets the qualifications: a university course in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology or biology, covering a defined syllabus, plus at least two years of practical experience in qualitative and quantitative analysis of medicinal products in an authorised manufacturer. Article 51 sets the duties: for batches manufactured in the EU, to certify that each batch was produced and checked in accordance with the marketing authorisation and the law; for batches imported from third countries, to certify that each batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all other tests needed to ensure quality, unless a mutual recognition agreement removes the need for retesting.

Annex 16 of EudraLex Volume 4 explains how certification works in practice. The QP signs a register or equivalent for each batch before release, may rely on the quality systems of other sites and on confirmations from other QPs for partial manufacturing steps, and remains personally responsible for the certification. The QP also signs the declaration, included in Module 1 of marketing authorisation applications and variations, that the active substance used was manufactured in compliance with GMP for active substances.

The role is personal and national. A QP is named on the MIA, must be available to the site continuously, and can be removed by the authority for failing in their duties. Member States run their own eligibility assessments and, in some cases, professional registers.

What goes wrong: a QP certifies a batch whose manufacturing site is not yet approved in the marketing authorisation; the QP declaration on an active substance manufacturer is signed without an audit the QP can stand behind; a single QP is listed for several sites with no deputy, so releases stop when they are absent; and imported batches are released on the basis of third-country test results without the EU retesting Article 51 requires or an MRA that covers that product. Each of these is a GMP inspection finding and can be a ground for suspending the authorisation.