For companies manufacturing or importing medicinal products into the EU or UK, the role of the Qualified Person (QP) is a mandatory regulatory requirement. What exactly is a QP, and why is this role so important?
What is the Role of a Qualified Person?
A Qualified Person (QP) is a highly trained and experienced professional who is legally responsible for ensuring that medicinal products meet all required quality, safety, and regulatory standards before they are released to the market or for use in clinical trials.
The QP must certify that each batch of a medicinal product has been manufactured and tested in accordance with Good Manufacturing Practice (GMP), the product’s Marketing Authorisation/Clinical Trial Authorisation, and all applicable regulations.
Why is a QP Required?
The QP requirement was established to protect patients and maintain confidence in the supply chain of medicinal products. Before any medicinal product can be distributed in the EU or UK, a QP must formally certify that the batch complies with regulatory requirements.
This independent oversight helps to:
- Ensure patient safety
- Verify compliance with GMP regulations
- Confirm product quality and consistency
- Support regulatory inspections and audits
- Reduce the risk of defective or non-compliant products reaching the market
When is QP Certification Needed?
QP certification is required for:
- Commercial (‘to-market’) batch release of medicinal products:
- Manufactured within the EU or UK
- Imported from countries outside the EU or UK
- Investigational Medicinal Products (IMPs) used in clinical trials
Without QP certification, medicinal products cannot legally be released for sale or supply within the relevant market or for use in clinical trials.
Can I Outsource the QP requirement?
Many pharmaceutical and biotechnology companies choose to outsource QP responsibilities to experienced consultants or specialist service providers like HiTech Health. External organisations can support organisations with batch certification, GMP compliance, quality oversight, regulatory inspections, and supply chain management. However, it is important to do a thorough due diligence and select an experienced and trusted provider.
By partnering with an experienced company like HiTech Health, companies can ensure compliance with complex regulatory requirements while maintaining efficient product release timelines. The Qualified Person plays a vital role in safeguarding the quality and safety of medicinal products across the EU and UK. Whether for routine batch release, product importation, or clinical trial supply, QP certification is a legal requirement that helps ensure patients receive medicines that meet the highest standards of quality and compliance. 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.