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A Qualified Person (QP) is essential to the safe control of medicines.
European Union pharmaceutical regulations state that no batch of medicinal product can be released for sale or supply without certification issued by a QP stating that the batch has been manufactured in accordance with the relevant requirements and legislation.
Therefore the primary legal responsibility of the QP is to certify batches of:
- Medicinal products prior to use in a clinical trial (human medicines products only)
- Medicinal products prior to release for sale and placing on the market (human and veterinary medicinal products)
A QP needs to have extensive training, experience and in-depth critical understanding of all the aspects associated with pharmaceutical manufacturing.
