WORKING GROUP OBJECTIVES AND MILESTONES
Objectives
The main Objectives of the
Supply Chain Control Framework (SCCF) Project Working Group are summarized as follows:
Practical solution in joint agreement, as simple as possible
The main objective of the Working Group is finding a solution with the
highest rigor, as simple as possible, from a practical approach that could be feasible for both distribution and pharmaceutical companies, and accepted by the Health Authorities.
Establishing a document (Framework agreement)
The document to be elaborated will take into consideration quality, efficiency and feasibility aspects. It will allow the following among others:
Harmonizing the naming convention used in the identification of the supply chain agents.
Establishing the risk analysis methodology for each agent
Establishing the Quality System required for agents and distributors, the specific acceptance criteria as well as the audit needs. This will allow distributors offering an added value for its services.
Establishing which activities can be delegated to the distribution companies and who retains the related documentation, which should be made available for the Health Authorities as required.
Creation of a Quality Agreement template between the pharmaceutical and distribution companies.
Review by the Health Authorities
The resulting document from the SCCF Project will be reviewed by the Health Authorities.
Milestones
Supply Chain Control Framework (SCCF) Project Initial Meeting. September 15th, 2011.
On September 15th 2011 the first meeting for the
Supply Chain Control Framework (SCCF) Project was held at the Hesperia Presidente Hotel in Barcelona. The meeting was organized by Forum Auditorías. The event was a high attendance success including representatives from pharmaceutical and distribution companies. It should be highlighted that Mr. Sr. Salvador Cassany (Pharmaceutical and Medical Devices Control Service Officer from the Health Department of the Generalitat) participated in the meeting as Health Authorities representative.
See meeting minutes for further details.
Creation of the Working Group for the Supply Chain Control Framework (SCCF) Project. September 28th, 2011
Draft document presentation from Forum Auditorías. The Draft will be used as the initial working document for the group. Beginning of October, 2011.
Working Group meeting. October 28th, 2011.
First version of the document for the interested companies’ consultation. November 2011
Working Group discussion based on the received comments. December 2011
Final Edition of the document. January 2012
Supply Chain Control Framework (SCCF) conference, which will be held in Barcelona on May 4th, 2012.