EMA: Q&A on the Implementation of 3DP Technology for Solid Oral Dosage Forms
EMA added a new GMP/Q&A section on its website and published a dedicated Q&A document on 3D printing (3DP) for solid oral dosage forms.
The document frames 3DP as an emerging manufacturing technology and sets out quality and GMP expectations for development, control strategy, process validation, equipment qualification, software/computerised systems, cartridge or syringe intermediates, and batch certification/release.
For manufacturers exploring decentralised, personalised, or small-batch production, this is a meaningful signal that EU regulators now expect formal pharmaceutical-development and GMP control strategies around 3DP rather than treating it as a purely novel technology discussion.
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