Seminar Nr. 9251
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Nikolaus Ferstl, University Hospital of Regensburg, Germany
Dr Johannes Krämer, CSL Behring
Dr Jean-Denis Mallet, ECA & Former Head of 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 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.
Layout, air-locks, personal and materials flow
Ceiling, walls & floor (cleanability & persistence)
- assignment of different systems to the clean room classes A-D (E)
Barrier systems vs. clean room class A
Gap Analysis, Risk Assessment, and Planning
Definition of Project Targets
Guidelines and Cleanliness classes
Approach with not-sterile dosage forms
Typical project model
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
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 personal flow during the construction time
Monitoring and documentation
Lessons learned - Practical experience with layout, HVAC systems, utilities
Initial Situation and Objectives
Definition of Requirements
Development of layout and zone concept
Concept development technical building services
Workshop: GMP upgrade at CSL Behring
In this practical workshop you are confronted with the real situation of CSL Behring. You will find the real initial layout, process and material flow and the requirements which have to be fulfilled. You will define the risks, define a project schedule and define a new layout with help from the teaching team. Your results will be discussed in the group and will be compared to the real conditions of CSL Behring after the re-modelling project.
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
Clean room interior
Specifics for renovation work during ongoing manufacture