The Qualified Person function has been defined in the EU Directives for around 50 years (since 1968 in the UK, since 1975 for EU).
When Directive 2001/83/EC was published repealing Directive 75/319/EEC, the articles regarding the Qualified Person were retained.
In the last 50 years, pharmaceutical companies have changed and their organisations have evolved, while the requirements and obligations of the Qualified Person have remained largely unchanged in the Directives.
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 manufacturing authorization holders.
The goals of this survey are as follows:
1) Understand the position of the QPs within the organization of the manufacturing authorization holder
2) Understand the position of the QPs among other fellow QPs working for the same manufacturing authorization holder
3) Understand the differences between the organisation of QPs responsible for commercial or investigational medicinal products.
4) Understand how the manufacturing authorization holder enables the QPs to carry out their duties and fulfil 2001/83/EC Article 46 (e).
We would appreciate it if all our EQPA members with past and present experience as QPs would complete this survey, as well as forward the survey link up the hierarchy to the Heads of QA/Quality Unit/Heads of Quality Control and Production in their companies, to obtain not just the QP’s view of their position in the organization, but also the view of the manufacturing authorization holder (as represented by the Managers and Heads of QA) on the position of the QPs they have at their disposal.
Your EQPA Team