In the European Union (EU), the release of medicinal products for commercial supply is a highly regulated activity. Central to this release process is the Qualified Person (QP), a legally defined role under EU pharmaceutical legislation. The QP is responsible for ensuring that every batch supplied to the market meets the required standards of quality, safety, and compliance.
What Is a Qualified Person?
A Qualified Person is an individual named on a Manufacturer’s / Importer’s Authorisation (MIA) who meets specific education, training, and experience requirements to fulfil the role. The QP acts as the final accountable authority for batch certification prior to commercial distribution within the EU.
Key Responsibilities in Commercial Batch Release
Prior to certifying batches for market supply, the QP has to ensure:
- The medicinal product has been manufactured and tested in accordance with EU GMP and the approved Marketing Authorisation (MA).
- All manufacturing, testing, and packaging steps have been completed and documented in line with GMP requirements.
- Any deviations, changes, or out-of-specification results have been appropriately investigated and resolved.
- For imported products, manufacturing and quality controls conducted outside the EU are equivalent to EU GMP requirements.
Why the QP Role Matters?
The QP function is a critical component of the EU pharmaceutical regulatory system. It provides regulators and patients with assurance that medicinal products released to the market consistently meet EU standards, regardless of where they are manufactured. The role of the QP carries legal responsibility, with individual accountability to EU competent authorities for each certified batch. This responsibility underpins the assurance that product quality and patient safety consistently meet the highest regulatory standards.
For companies supplying medicinal products in the EU, access to an experienced QP team will help ensure timely and uninterrupted commercial supply. HiTech Health is a leading provider of QP services in the EU and also the UK. Our QP team have extensive knowledge of pharmaceuticals, biologics and Advanced Therapeutic Medicinal Products (ATMPs) including cell and gene therapies. We can help with all quality and compliance activities from your overall quality management system through quality audits and QMS remediation support.
Contact our team today and schedule a call to learn more about our QP services for the EU and UK markets.