Artanes

Packaging & Repackaging

GMP-Compliant Solutions for Secondary Packaging

Artanes Ltd. offers integrated solutions for the secondary packaging and/or repackaging of medicinal products, in full compliance with Good Manufacturing Practice (GMP) and applicable European regulations. Regardless of batch volume, packaging type, or specific storage conditions, we guarantee traceability, control, and full transparency at every stage of the process.

Scope of Activities:

Repackaging

The repackaging process includes:

  • Verification of medicinal products (in accordance with anti-falsification safety requirements).
  • De-packaging under controlled conditions.
  • Secondary packaging (re-boxing).
  • Sealing.
  • Serialization.
  • Batch release by a Qualified Person (QP).

Packaging

The packaging process includes all the activities listed above, except verification and de-packaging.

Packaging Materials

We work with both client-provided materials and packaging developed and/or manufactured in-house.

When developed by us:

  • Designs are created in accordance with regulatory requirements.
  • A physical sample is provided for client approval.
  • Production commences only after written confirmation.

All packaging materials undergo rigorous incoming quality control and are handled in accordance with approved procedures.

Serialization and Data Management

We offer flexible serialization management:

  • ​​​​​Capability to generate serial numbers or utilise those provided by the client.
  • Reporting of serial numbers for manufactured products to the EMVO (European Medicines Verification Organisation) or providing them to the client in the required format for independent serialisation.

Control, Documentation, and Traceability

With every processed batch, the client receives:

  • A comprehensive Batch Record (Batch Documentation).
  • Temperature data logs covering the entire storage and processing period.

All activities are performed in accordance with validated procedures, ensuring full traceability and regulatory compliance.

Quality Assurance

Our processes are built upon:

  • Strict adherence to GMP requirements.
  • Highly trained and qualified personnel.
  • A controlled environment and validated processes.
  • Full transparency for the client.

Contact

If you have any questions, please feel free to submit an inquiry HERE.