The Asociación Fórum Auditorías (AFA) coordinates working groups to be able to address the challenges related to the constantly changing regulatory environment and to improve the operating procedures related to the supply chain qualification.

Currently, AFA is leading the following Working Group:

Chain Control Framework (SCCF) Project

The mail goal of the project is the definition of a methodology for the supply chain control of raw materials for the pharmaceutical industry and according to the 2011/62/EC Directives.

In today’s global environment, the characterization and control for each link of the supply chain, including change control, is very complex for the pharmaceutical industry.

The Qualified Person (QP) is responsible to guarantee the quality of the products to be released to the market. This responsibility includes the overall supply chain and its control. The documentation derived from the control actions of the supply chain will be subjected to inspection. In addition, this point will be included in the Qualified Person declaration when a new dossier, an update or a variation is submitted to the relevant Health Authorities.

During the last years, the distribution companies have evolved from material buying/selling to companies assuming control on the quality and the “pedigree” of the commercialized products. They have resources, infrastructure, knowledge and a quality system to manage successfully the supply chain control. The only point not covered occasionally is the transportation from the manufacturing plant to the airport or port from which the material is shipped.

Although the ultimate responsibility of the supply chain control lies with the Qualified Person, the associated control tasks can be delegated, provided that, the working and acceptance criteria, methodology and documentation to be generated to maintain traceability have been established.

The SCCF Project is intended to establish the basis for the mentioned delegating process in such a way that it is feasible and acceptable for both pharmaceutical companies and Health Authorities. Besides, it should be feasible for the distribution companies. An agreement between companies can even solve the characterization of the transport operators covering the transportation from the manufacturing plant to the airport or port. This step could be inspected as part of the audits performed to manufacturers.

An interdisciplinary working group has been created, including representatives from:

Pharmaceutical Companies receiving raw materials and ultimate responsible for the absence of risk for the patient in the final pharmaceutical product.

Distributors. Companies specialized in Chemical substances distribution with supply chain expertise. The supply chain knowledge provides value to its clients

Health Authorities having the responsibility for establishing the minimum requirements to be met for public health protection while monitoring its compliance

Forum Auditorías. Association of Pharmaceutical companies specialized in the organization, execution and follow-up of GMP audits for raw materials manufacturers.

This group is working in the elaboration of a document allowing:

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.

The reviewed document is expected to be available to all the interested companies and Health Authorities during January 2012.