Nikolaus Ferstl, University Hospital of Regensburg
Dr Johannes Krämer, CSL Behring
Dr Jean-Denis Mallet, Former Head of the French Pharmaceutical Inspection Dpt. AFSSAPS
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 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.
Another 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.
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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.
- Layout, air-locks, personnel and materials flow
- HVAC Systems
- Ceiling, walls & floor (cleanability & persistence) – assignment of different systems to the clean room classes A-D (E)
- Barrier systems vs. clean room class A
- Clean media
Gap Analysis, Risk Assessment, and Planning
- Definition of Project Targets
- Guidelines and Cleanliness classes
- Approach with non-sterile dosage forms
- Typical project model
- Project Management
How Authorities consider Facility Modifications?
- What are the regulatory expectations before starting construction work?
- How to document the change file from a technical and regulatory point of view ?
- Communication with the authority in charge
- Implementing the changes & modifications
The real World – Dealing with poorly documented Facilities/Systems
- Clarify the feasibility of a rebuild
- Preparation and processing of missing documentation
- Involvement of authorities and Consultants
- Authority documentation
Measures for protecting the ongoing Manufacture
- Protection of floor, ceiling and walls
- Protection of bulk and finished products
- Protection from dust
- Handling external workers, access control, Training
- Material and personnel flow during the construction time
- Monitoring and documentation
Case Study: GMP-Upgrade at CSL Behring: Upgrading of a Manufacturing Area to Clean Room class C
The premises of CSL Behring in Marburg did not meet the actual GMP requirements. Therefore process equipment, HVAC System and the clean rooms themselves underwent a GMP upgrade. Another aim was to optimise the whole flow of the process. All was done during ongoing manufacture under GMP conditions.
- Starting situation and objective
- Project plan, milestones, timelines
- GMP requirements
- Clean room interior
- Specifics for renovation work during ongoing manufacture
- Lessons learned
Lessons learned – Practical Experience with Layout, HVAC Systems, Utilities
- Initial Situation and Objectives
- Definition of Requirements
- Development of layout and zone Concept
- Structural Measures
- Concept development technical building services