GMP – Green or Good Manufacturing Practice?

Objectives

This conference track will take a closer look at and discuss the possibilities of sustainability, environmental thinking and energy saving also under GMP conditions. The extent to which regulatory requirements, quality demands and modern sustainability requirements fit together will also be a topic of discussion. Case studies will be used to present practical implementations and highlight improvement measures.

Background

In the past, compliance with quality requirements and safety aspects in the manufacture of drugs, active ingredients, etc. was often the primary focus. Environmental aspects, energy costs, water consumption and the like were usually not at the top of the priority list. This has changed in recent years - under the influence of climate change, rising energy prices, increased transport costs and scarcity of raw materials. Buzzwords like Sustainability or Green GMP are heard more and more often. On the one hand because of the increasing environmental problems and on the other hand because of the rapidly rising costs for energy, water and raw materials. The challenge is often how to combine the requirements of GMP and sustainability.


GMP – Green or Good Manufacturing Practice?

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Target Audience

This conference track is aimed at all persons in the field of manufacturing, facility management, quality assurance and quality control who have to deal with the problems of suatainability aspects under the regulation of GMP.

Registration

Detailed Programme

Tuesday, 19 March 2024

Sustainability and GMP – Contradictive or supportive? How can Sustainability Aspects been built in GMP Requirements
Dr Andrea Bauer, ABC&Q

  • Expectations of stakeholders
  • Embedding sustainability in entire product life cycle
  • Supporting and contradicting expectations and requirements

Reading the EU-GMP Guide with green Glasses
Dr Jean-Denis Mallet, Former head of the French Inspection Department AFSSAPS, Pharmaplan

  • The Green target
  • Type of actions that really be deemed Green
  • Reading the guide with Green Glasses : the main promising points
  • How much Green actions will be impacting the marketing authorization dossier ?
  • Conclusion

Does Sustainability stand only for Green GMP?
Ana Cláudia Pinho, Bial Portela
Susana Lima, Bial Portela

  • What does Sustainability mean – Environment Saving? Green?
  • Other Aspects
  • Social responsibility
  • Economic viability
  • Ethical considerations

Sustainable and Energy-Efficient Planning and Construction of a Laboratory and Production Facility
Dr Johannes Reich, Microcoat Biotechnologie

  • Planning of a new Laboratory and Manufacturing Complex
  • Solar and water - energy generation and storage
  • Heating and cooling - modern possibility of sustainability
  • Pros, cons and pitfalls
  • Costs and ROI

Sustainability – HVAC Optimization Program at Merck Healthcare KGaA with significant Energy Savings
Lenz Kunath, Merck Healthcare

  • Challenge “regulated” air change rates, use other criteria to determine room cleanliness
  • Reduce permanent air change rates
  • Reduce air change rates during non-productive times
  • Challenges executing the program

How to reduce Carbon & Water Footprint in clean Utility Systems
Alistair Wotherspoon, CRB

  • Reducing the carbon burden of aseptic products is an uphill battle for manufacturers still latching on to WFI by distillation
  • In 2017, the European Pharmacopeia joined the majority of pharmacopeias around the world allowing for alternative methods of generating WFI—methods far less demanding on energy and water than that of distillation
  • It’s time to reevaluate the WFI systems
  • Industry is poised to make the move to benefit the environment and find resiliency against energy uncertainty
  • User case from an ongoing project at Lonza

Sustainability in Pharma – how a Company can achieve CO2 net zero Goal
Henning Austermann, Siegfried
Markus Burkert, Syntegon

  • Siegfried's goal of climate neutrality
  • Projects and activities - from green electricity to district steam and heating
  • CO2 analysis and optimization of machine park
  • Further prospects and potentials, e.g. sustainable raw materials
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