Renovation & Upgrading of GMP Facilities - Online Training Recording

Course No. 21437



Nikolaus Ferstl

Nikolaus Ferstl

Facility Engineering Services

Dr Jean-Denis Mallet

Dr Jean-Denis Mallet

Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS

Dr Johannes Krämer

Dr Johannes Krämer

CSL Behring


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.

Target Group

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.

Technical Details

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation


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
  • Equipment
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
  • Risks
Measures for protecting the ongoing Manufacture
  • Protection of floor, ceiling and walls
  • Protection of bulk and finished products
  • Protection from dust
  • HVAC
  • 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
  • HVAC
  • 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
Recording from 15/16 November 2023
Duration of Recording: 8h 53min


This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager" Learn more

ECA-Member*: € 1690,-
Regular Fee*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
Further dates on-site
Not available
Further dates online
Further dates online
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0

Woman with headset

Go back

Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023


“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024


“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024



“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023