Logo NANOPILOT PROJECT

Work Packages

The project will last 48 months, and the work plan has been divided in 8 Work Packages

 

Work Package structure

WORK PACKAGE 1

Definition of nanopharmaceuticals and design of their GMP production process.

LEADER: NATIONAL UNIVERSITY OF IRELAND, GALWAY

This WP includes the definition of requirements and specifications for: each nanopharmaceutical and scaling-up and manufacturing plans. Gaps for implementation will be identified

WORK PACKAGE 2

Adaptation of the facilities to a nanopharmaceuticals production pilot plant working in compliance with GMP.

LEADER: IK4-CIDETEC

WP2 will include the design and adaptation of actual facilities. A LIMS will be implemented and validated. A manually controlled continuous flow microfluidic system will be designed and adapted for GMP operation.

WORK PACKAGE 3

Training System implemetation.

LEADER: MEJORAN

WP3 will develop a training system in concordance with WP4. It will be developed in concordance, also, with WP2 in order to obtain a trained staff capable to administer and use the system as the pilot plant and GMP conditions require.

WORK PACKAGE 4

Quality System (QS) implementation.

LEADER: ADERA-UT2A

The implementation of the QS will be based on the scheme proposed on the ICH (International Conference of Harmmonization) guidelines. Specifically following the ICH Q10 (Vol 4).

WORK PACKAGE 5

Validation of manufacturing processes and production of nanopharmaceuticals in compliance with GMP.

LEADER: IK4-CIDETEC

The production procedures and in-process controls for each nanopharmaceutical will be validated during this WP. These processes will be carried out and recorded according to GMP guidelines.

WORK PACKAGE 6

Shipping and Batch release.

LEADER: SYLENTIS

WP6 will be focused on nanopharmaceuticals batch release starting from establishing the procedures to obtain authorization for their manufacturing until shipping them to its sponsor.

WORK PACKAGE 7

Development of a Business and Dissemination Plan.

LEADER: SPINVERSE

WP7 will lay the foundation for economical sustainability of the future plant. A strategy to make NanoPilot known will be created. Plans for exploitation of the outcomes, including IPR-strategy, will be established to finally deliver a business plan.

WORK PACKAGE 8

Management.

LEADER:IK4-CIDETEC

WP8 will guarantee optimal administrative, financial, contractual as well as scientific consortium management and enable efficient communication between all partners.