The Intercompany Protocol constitutes the basis of agreement between the affiliates. It is the charter for the organization, realization and distribution of audits and audit reports.
The Intercompany Protocol includes topics such as:
- Terms and conditions necessary to support the regulation (confidentiality, auditors (profile and qualification program), absence of conflict of interest, criteria for sharing audits, audit planning and organization, access to available audits, validity of audit reports).
- Methodology to carry out audits (acceptance criteria, criticality, observation classification, audit execution and follow-up).
- Description of the audit report.
The Intercompany Protocol constitutes the Asociación Fórum Auditorías (AFA) regulations to develop joint programmes for the validation of suppliers, which is one of the key activities to guarantee the quality of pharmaceutical products and therefore of Good Manufacturing and Distribution Practices compliance.
The first version of this document was created, reviewed and ratified by a group of 16 pharmaceutical manufacturing companies. Due to their interest in conducting audits to suppliers, a framework agreement called Intercompany Protocol was developed to perform audits to suppliers in a collaborative manner as well as to put in common information related to suppliers.
The development and co-ordination of the document and meetings leading to the Intercompany Protocol issuance were done by the company TDV S.L.
The document has been reviewed several times in order to totally adapt it to what is established by the Health Authorities and the agreements made in the Assembly for the continuous improvement of audit management and execution. The current document (5th revision) is effective since June 2018.