08 November 2023
The position of the QP within the organization of the manufacturing authorization holder
The Qualified Person function has been defined in the EU Directives for around 50 years (since 1968 in the UK, since 1975 for EU).
The EQPA would like to understand to what extent the role and function of the Qualified Person has evolved, in response to the changes and evolution of the pharmaceutical companies that are manufac-turing authorization holders. Specifically, we would like to get a better understanding of
1) the position of the QPs within the organization of the manufacturing authorization holder
2) the position of the QPs among other fellow QPs working for the same manufacturing authorization holder
3) the differences between the organization of QPs responsible for commercial or investigational me-dicinal products
4) how the manufacturing authorization holder enables the QPs to carry out their duties and fulfil 2001/83/EC Article 46 (e)
We would therefore appreciate it if you as a QP with past and present experience completed this survey as well as forwarded the survey link up the hierarchy to the Heads of QA/Quality Unit/Heads of Quality Control and Production in your companies.
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