The Role of the Qualified Person (QP) in the Pharmaceutical Industry
The position of Qualified Person (QP) in life sciences comes with specific responsibilities. The QP must ensure that certain pre-requisites are fulfilled as described in Annex 16 of the EU GMP Guide. The QP is responsible for ensuring that each batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, following the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP).
Cor: As a QP, I am responsible for the release of medicinal products through batch certification. This means that I review the documentation covering the entire production and quality control process, including defects or deviations from the process or product. The objective is to deliver an effective and safe product to the patient. Before batch certification can take place, the QP should ensure that all critical manufacturing and quality control processes are validated according to the GMP guidelines.
The QP must rely on the Pharmaceutical Quality System (PQS) of the pharmaceutical company and should have an ongoing assurance that this reliance is well-founded. This requires a comprehensive understanding of the quality systems in place, such as those for handling deviations, out-of-specification (OOS) results, complaints management, and excursion management in environmental monitoring. In addition to these so-called ‘problem-solving’ processes, I should also have knowledge of the ‘compliance & oversight’ procedures in a pharmaceutical company, such as annual Product Quality Reviews (PQR), change control, and regulatory compliance. The batch is only released on the market once all products from that batch have been certified.
Recent Regulatory Updates Impacting the QP Role
In 2023, the European Medicines Agency (EMA) published Q&A’s on remote batch certification / confirmation by the QP. These Q&A’s aim to provide minimum requirements and additional interpretations for remote batch certification. These should ensure traceability and reduce human error in the release process. This shift means that QPs may increasingly rely on digital platforms for documentation review and batch certification, in line with modern trends in pharmaceutical manufacturing.
When a QP releases a statement bearing their signature, they are personally responsible for its release. Oversight of ongoing investigations—such as complaints, out-of-trend results, and recalls—is necessary to evaluate their impact on batch certification. This supervision ensures that medicinal products are manufactured according to GMP and MA guidelines, underscoring the significant responsibility of the QP. In Europe, every company should have access to a QP, and the number of QPs should correspond with the number of batches produced by the company.
With the evolving regulatory landscape, Progress Life Sciences can quickly and flexibly help organizations within life sciences needing a QP. Having a QP already registered with the Inspectorate accelerates the accreditation process, making it faster for companies to meet regulatory requirements.
Ready to ensure compliance and smooth operations in your pharmaceutical company?
Progress Life Sciences is here to support you with our experienced and registered QP services. Whether you are seeking a full-time QP or need assistance for specific batch certifications, we offer flexible, fast, and efficient solutions tailored to your needs. Contact us today to learn more about how we can help ensure your products are compliant and ready for the market.
