Responsibilities of a qualified person
QP – Qualified person for batch release of medical products for human or veterinary use. The position of Qualified Person (QP) in a pharmaceutical company is a specific responsibility. It is the QP’s duty to ensure that certain pre-requisites are fulfilled as described in Annex 16 to the EU GMP Guide: ‘The QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP)’.
“As a QP, I am responsible for releasing medicinal products by batch certification.
Chantal: “This means that I review the documentation covering the entire production and quality control process, including defects or deviations from the process and/or product. The objective is to ultimately deliver an effective and safe product to the patient.”
Before batch certification becomes applicable the QP should ensure him/herself that all critical manufacturing and quality control processes are validated according to the GMP guidelines.
Chantal:” As a QP I must rely on the Pharmaceutical Quality System (PQS) of the pharmaceutical company and should have a ongoing assurance that this reliance is well founded. Therefore an understanding of the quality systems is required as for example (but not limited) deviation, out of specification (OOS), complaints management procedures as well as the procedures of excursions on environmental monitoring and recall. Besides these so called ‘problem solving’ procedures I should have also knowledge of the ‘compliance & oversight’ procedures in a pharmaceutical company as for example annual Product Quality Review (PQR), change control and regulatory compliance. The batch is only released onto the market once the products from that batch have been certified.
Chantal: “When a QP releases a statement bearing the QP’s signature, he or she is personally responsible for its release. The oversight regarding ongoing investigations (complaints, out of trends, recalls) is required to evaluate if those are not impacting the batch certification of any medical product.” This supervision by a QP is necessary to verify that a medicinal product was manufactured according to the GMP and MA guidelines and makes the responsibility of the QP significant. In Europe, every company must have access to a QP. Furthermore, the number of QPs in a company must correspond with the number of batches that company produces.
How can Progress-PME help you with this? Progress-PME has enough experienced Qualified Persons to be able to quickly and flexibly help companies needing a QP; accreditation by the Inspectorate is faster for QPs who have been registered as such before.