EU GMP – Clinical manufacturing & IMP Management

Manufacturing

  • Blinding of IMP – e.g., over-encapsulation of a solid oral formulation
  • Batch release and certification by QP (QP release services)
  • Capsules Manufacturing (e.g. Placebo Capsules)
Blinding of IMP euromed pharma
Primary Packaging of solid oral formulations

Packaging

  • Primary Packaging of solid oral formulations
  • Packaging of all formulations and high potency drugs in cooperation with qualified partners
  • Secondary packaging of all formulations and packaging designs at our production sites
  • Provision of user-friendly packaging materials, controlled to fit quality specifications

Labeling

  • Preparation of label text according to regulatory requirements
  • Label design to enhance compliance of trial subjects
  • Client’s corporate identity can be integrated into the label
  • Labeling with the mono-/bi-/multi-lingual label (multi-language booklet label, wrap-around label, with or without documentation part/tear-off label)
  • Robust procedures to avoid mix-ups
  • Re-labeling in case of changes, (e.g., protocol amendments, new ‘use-by date’)
  • Compliance with 2001/20/EC, GMP and national drug laws (e.g., AMG), protocol specifications
  • Tear-off label to document subject compliance & drug accountability

Services

  • Preparation of Emergency Envelops
  • Preparation of IMP section relevant to the IMP preparation
  • Preparation of international Master Label Forms
  • Selection of qualified packaging materials
  • Tailored packaging and labeling designs to meet study needs
  • Importation of IMP from extra-EU countries in agreement with EU requirements