Eltronic's Qualified Person ServicesDownload PDF
Qualified Person (QP)
Flexible QP service for release of medicinal products
To be able to release medinical products for commercial use or use in clinical trials, the products must be approved by a Qualified Person (QP).
Eltronic Pharma Engineering offers a flexible QP service giving you the option of hiring a Qualified Person for a specific task or period of time.
The QP will be named on your authorisation and take over the legal responsibility for release of the product in question
When to consider the flexible QP service?
You only release a few batches each year and the review load is low
You need to have medicinal products from a country outside the EU released for sale on the European market or for clinical trials in the EU
You are in need of a QP resource for a limited period of time
How it works
Full responsibility for the product release and the requirements for Good Manufacturing Practice
Case: Device to medicine
For a product release to a south pacific market, Contura International needed to change the status of a medical device to veterinary medicine. Reduced costs, increased speed to market and a project plan based on GAP analysis and former reports were some of the major requirements. Based on Eltronic’s experience with QMS, LEAN and project management, Contura turned to Eltronic for the GMP transformation of the project.
Eltronic has been appointed qualified person (QP) for the ongoing drug release.