Radiopharmaceuticals are also covered under the laws and regulations of pharmaceutical products. In addition to complying with GMP, these products must also meet specific nuclear regulations and safety requirements. In the design and qualification of a facility for radiotherapeutic products, knowledge of both GMP and nuclear regulations and safety aspects is essential. Progress possesses this combined knowledge. For GMP facilities within the radiopharmaceutical world, our consultants bring together two of Progress’s core strengths: Engineering and Quality. These forces are deployed together to achieve the desired solution.

Through close collaboration with the client and Progress colleagues, our consultants assist in mapping out and presenting the optimal setup for the facility to be realized, taking into account the apparent contradictions between nuclear safety principles (where the goal is to keep contaminated air inside the facility) and the cGMP requirements (where the goal is to keep the product clean through overpressure areas). The focus here is to arrive at the most efficient and safest possible solution.

From Concept Design to Full Project Delivery

At an early stage, layout drawings can be produced to make all decisions clear and to add various layers to them. This includes personnel flows, product flows, waste flows, utilities, and air pressures. In consultation with the client the existing process is mirrored against the new facility.

Alternatively, Progress can advise on new processes that fit the new facility. In the design phase, the design is optimized as much as possible. Progress has strong relationships with various market parties, enabling the flexible team to be expanded during the subsequent steps towards realization to ensure a quick and reliable delivery.

Once the design is ready, Progress can take on the complete project management or be part of the construction team to achieve a successful project.

We can also support you with implementation and/or upgrading your Quality Management System (QMS) and or implement a “GMP way of working” by educating your staff on GMP regulations and explaining why these rules are neccessary and applicable for radiopharmaceuticals. For all our quality services, see “Quality”

Progress has extensive knowledge and experience in all areas of GMP. This ranges from setting up a state-of-the-art facility, where the client is supported from the initial sketches to the qualification of the building and process. But also conducting inspection readiness programs and pre-inspection audits, project management of construction and/or compliance projects, and providing specific expertise. Progress is deployed for facilities ranging from laboratories producing clinical batches to production sites delivering pharmaceuticals to the market.