IMP Manufacturing
IMPs Manufacturing:
- Blinding of IMP (e.g., over-encapsulation of a solid oral formulation)
- Capsules Manufacturing (e.g. Placebo Capsules and API distribution in capsules by weighing)
- Batch release and certification by QP (QP release services)
IMPs Packaging
- Primary Packaging of solid oral formulations
- Secondary packaging of all formulations and packaging designs at our production site
- Provision of user-friendly packaging materials, to improve patient compliance (e.g., wallet packaging), controlled to meet quality specifications
Multilingual labelling options: adapting to global requirements
Innovative IMP labelling techniques
IMPs Labelling:
- Label design to enhance compliance of trial subjects according to Regulation EU 536/20214
- Labelling with the mono-/bi-/multi-lingual label (multi-language booklet label, wrap-around label, with or without documentation part/tear-off label)
- Re-labelling in case of changes, (e.g., protocol amendments, new ‘use-by date’)
- Compliance with Regulation EU 536/14, GMP and national drug laws (e.g., AMG), protocol specifications
- Tear-off label to document subject compliance & drug accountability
IMPs Services:
- Preparation of Emergency Envelops
- Preparation of IMPD section relevant to the IMP preparation
- Preparation of international Master Label Forms
- Selection of qualified packaging materials
- Tailored packaging and labelling designs to meet study needs.
- Importation of IMP from extra-EU countries in agreement with EU requirements and production of QP declaration
- Narcotics management for Clinical Trials
Useful links
Privacy Policy – Cookie Policy – Whistleblowing – Tenarris Mittal S.r.l. a Petrone Group Company®