In the European Union (EU), every holder of a GMP certificate, Manufacturing Importation Authorization (MIA), must have at least one permanent or contractual Qualified Person (QP). The QP has specific responsibilities and plays a significant role in companies that produce medicinal products. Each batch of medicinal products must be assessed and formally certified by a QP before being released and transferred into saleable stock for the EU and for export outside the EU. In this assessment and certification process, the QP must ensure that every aspect of manufacturing, analysis and controls meet local, GxP and Marketing Authorization (MA), or Clinical Trial Authorization (CTA) requirements.

The QP takes personal responsibility for the quality, safety, and efficacy of each batch she/he has certified. Not only will the QP monitor the compliance of each batch assessed, but the QP will also ensure that appropriate controls and safeguards are in place to ensure that the relevant batch and future batches comply with applicable regulations and guidelines, such as set out in Annex 16 Certification by a Qualified Person and Batch Release. Therefore, the QP must be aware of the current applicable GMP regulations and guidelines of the country or countries where the products are to be marketed and the requirements for marketing authorization or clinical trials. In addition, the QP must be knowledgeable about the manufacturing process, controls, and analytical methods.

How can we help you?

• We can provide a temporary contract QP (see Temporary Staffing) to guarantee timely batch release until your internal QP capacity is sufficient again.
• We can coach your internal Quality staff member(s) who are training to become a certified QP.
• We can provide contract QPs on an hourly basis in case your organization is a scale-up and the number of clinical batches produced is too small to have a permanent QP on your payroll.
  
  

Progress employs expert and experienced consultants who are registered as QP for several types of (bio-)pharmaceutical products, including developmental products and ATMPs. These consultants can be contracted to be registered as QP for your organization. They can help you maintain a continuous flow of certified batches released for sale to the market and/or your clinical trials.

Why hire contract QPs from Progress?

Our contract QPs have been deeply involved in clinical programs, process validation, regulatory submissions, GMP inspections, and in the commercial production of a wide range of products. With their broad knowledge, experience and seniority, they take on the responsibility of helping you ensure compliance of your product and processes, timely batch certification and supply chain security.

As a contracted QP, our consultants will take responsibility and continuously emphasize compliance awareness and process efficiency within your organization.