In the European Union (EU), each holder of a GMP certificate, Manufacturing Importation Authorisation (MIA), must have at least one permanent or contract Qualified Person (QP). The QP has specific responsibilities and plays an important role in medicinal product manufacturing companies. Each batch of medicinal product must be evaluated and formally certified by a QP prior to release and transfer to saleable stock for the EU and for export outside the EU. In this review and certification process, the QP must ensure that every aspect of manufacturing, analysis and checks meet the local-, GMP- and Marketing Authorisation (MA) requirements. Moreover, the QP takes personal responsibility for the quality, safety and efficacy of each batch she/he has certified.
The QP will not only control the compliance of each reviewed batch, but the QP will also ensure there are suitable controls and safeguards to ensure that the relevant batch and future batches are compliant with the applicable regulations and guidelines. Therefore, the QP should know the current GMP regulations and guidelines, the requirements from the MA or clinical trial authorisation, and be well informed about the production process, its controls and analytical methods.
How can we help you?
- We can provide a temporary contract QP to assure timely batch release until your internal QP capacity is sufficient again.
- We can coach your internal Quality staff member(s) who are in training to become a certified QP
- We can provide contract QP’s on an hourly basis in case your company is a scale-up and the number of produced clinical batches are too small to have a permanent QP on your payroll.
Progress has Knowledgeable and experienced consultants under employment that are registered as QP for different types of (bio-)pharmaceutical products, including developmental products and ATMPs. These consultants can be contracted to be registered as QP for your company. They can help you to maintain a continuous flow of certified batches to be released for sale to the market and/or your clinical trials.
Why hire contract QP’s from Progress
Our contract QPs have been highly involved in clinical programs, process validation, regulatory submission and GMP inspections and in commercial manufacturing of a wide range of products. With their broad knowledge, experience and seniority, they will take responsibility to help you to ensure compliance of your product and processes, timely batch certification and supply chain assurance.
As contracted QP, our consultants shall take ownership and continuously emphasise awareness for compliance and process efficiency within your organization.