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This course aims at showing GMP-compliant layout and state of the art clean room technology for GMP production areas, which have to be built in existing manufacturing premises. Next to project management, the securing of the GMP status of the ongoing manufacture during the construction work is a main topic of this course.
The number of new factory buildings in the pharmaceutical industry in Europe decreases while upgrading and renovation of existing manufacturing sites is getting more and more relevant. Regardless of whether the upgrade is done in order to extend the facilities’ capacity or if whether it was necessary due to GMP issues: upgrading is much more challenging than construction in the Greenfield. For example, the existing infrastructure of the building has to be taken into account, although the existing documentation is most often not complete. Nevertheless the users’ requirements for layout and process flow have to be fulfilled as well as the demands from authorities with regard to the cGMP requirements.
Anther common issue is that the actual state is differing from the documented status. And, also quite frequent, the available space is restricted, and bringing in new equipment is sometimes tricky.
But one of the biggest issues and most important differences to construction on the Greenfield is the ongoing manufacture in the existing building. It is unavoidable to take measures to secure the manufacturing area from the parallel construction work and dust and from the uncontrolled access through foreign workers. Moreover, it has to be proven that construction work had no influence on the quality of the batches.
The existing personnel and material flow also has to be considered. For example, bringing in raw materials can possibly be a problem during the construction phase.
This course is targeting professionals responsible for the planning and realisation of upgrading and refurbishment projects. It further addresses engineers and project mangers from pharmaceutical companies as well as from engineering companies.
Basic requirements for pharmaceutical facilities
Before starting renovation of an existing facility or doing a GMP upgrade, it is important to know what today’s cGMP requirements for sterile and non-sterile facilities are.