Microplastics (10667)

The description, assessment and documentation of impurities in drug substance, excipients, drug product and packaging material are an essential part of the quality and safety of a drug during its life cycle. The main frame and rules are documented in official guidelines and pharmacopoeias; however, not all relevant aspects are covered by the regulatory documents. One of these emerging but often neglected topics is the burden of microplastics in medicinal products and the environment and its proper handling and documentation.

In September 2022 the European Commission published a draft regulation to amend Annex XVII to Regulation (EC) No 1907/2006 regarding the use of synthetic polymer microparticles after publication in 2020 of the Annex XV Restriction proposal on intentionally added microplastics by European Chemicals Agency (ECHA).

The following aspects will be presented and discussed: 

• Sources, fate and effects of microplastics in the marine environment – a global assessment 
• Microplastics regulation – an overview of regulations 
• Proposed EU rules on small particles 
• EFPIA position on the ECHA microplastics restrictions 
• How to document according to the ECHA's proposal for an EU-wide restriction on intentionally added microplastics. Implications for pharmaceutical excipients, medicinal products and food additives  
• Presence of microplastics and nanoplastics in food and pharmaceuticals 
• Recommendations for quantifying synthetic particles in pharmaceutical drug substances and products 
• Interaction between microplastics and pharmaceuticals, depending on the composition of theaquatic environment 
• Physicochemical properties of microplastics, specific adsorption modeling and their interaction with pharmaceuticals and other emerging contaminants 

• Future regulatory landscape for pharmaceutical excipients: nanoparticles and microplastics 

Duration: 90 minutes
Lecture language: English | Slides: English

...your speaker Dr. Helmut Buschmann...
...your speaker Dr. Norbert Handler...

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Note on quota call-off: When booking this single part described here, one part per participant will be deducted.